Teriparatide

updated

Teriparatide is an FDA-approved PTH 1-34 injection (FORTEO, 2002) for osteoporosis at high fracture risk, with a 1,637-woman fracture trial and a 1,360-woman active-comparator trial behind it. The height use has no human trial: PubMed and ClinicalTrials.gov searches on 9 October 2026 found none in healthy children or children with short stature, the label says to avoid use with open epiphyses, and the only growth-plate stimulation found was in young rats.

Parathyroid hormone analog (PTH 1-34)

  • FDA approved FORTEO under NDA 021318 on 26 November 2002; the label's initial US approval year of 1987 refers to an earlier teriparatide product.
  • In 1,637 postmenopausal women with prior vertebral fractures, new vertebral fractures occurred in 14% on placebo versus 5% and 4% on teriparatide over a median 21 months.
  • In VERO (1,360 women, 24 months), new vertebral fractures occurred in 5.4% on teriparatide versus 12.0% on risedronate, and nonvertebral fractures did not differ significantly.
  • A PubMed search on 9 October 2026 returned 3 records on teriparatide with height or growth terms in children; none tested height in healthy children or children with short stature.
  • The label says to avoid use with open epiphyses and says FORTEO is not approved in pediatric patients.
  • The osteosarcoma boxed warning was removed under a labeling change dated 16 November 2020; surveillance estimates are close to no increase but imprecise, with 3 observed cases in each analysis.

What is teriparatide approved to do?

FDA approved FORTEO (teriparatide) on 26 November 2002 for osteoporosis at high fracture risk in postmenopausal women, in men with primary or hypogonadal osteoporosis, and in glucocorticoid-associated osteoporosis. FORTEO is not approved in pediatric patients.

FORTEO, a PTH 1-34 analog, is labeled for postmenopausal women with osteoporosis at high fracture risk, where it reduces vertebral and nonvertebral fractures. It is also labeled to increase bone mass in men with primary or hypogonadal osteoporosis at high fracture risk, and for glucocorticoid-associated osteoporosis at high fracture risk. FORTEO is not approved in pediatric patients. The label version used here took effect on 3 August 2026.

FDA approved FORTEO under NDA 021318 on 26 November 2002. Later teriparatide products include BONSITY (NDA 211939, 4 October 2019), a Teva generic (ANDA 208569, 16 November 2023), an Almaject product (NDA 218771, 4 June 2024) and an Amphastar generic (ANDA 213641, 12 December 2025). openFDA also lists PARATHAR, a discontinued teriparatide acetate injectable (NDA 019498), without an approval date. The label's initial US approval year of 1987 refers to an earlier teriparatide product, not FORTEO.

Teriparatide is recombinant or synthetic human PTH 1-34 (C181H291N55O51S2, 4118 g/mol, CAS 52232-67-4). Products differ in how the peptide is made: FORTEO uses a modified strain of Escherichia coli, BONSITY uses Pseudomonas fluorescens, and the Teva product is made by chemical synthesis. Research-grade teriparatide acetate also appears in DailyMed as a bulk powder listing from Bachem, which is not a finished drug product.

FORTEO label, version effective 3 August 2026: indications, osteosarcoma warning, PK

FDA prescribing information

DailyMed, U.S. National Library of Medicine. FORTEO (teriparatide injection) prefilled pen, subcutaneous, prescribing information, label version effective 3 August 2026. Set ID aae667c5-381f-4f92-93df-2ed6158d07b0.

FORTEO, a PTH 1-34 analog, is labeled for postmenopausal women with osteoporosis at high fracture risk (where it reduces vertebral and nonvertebral fractures), to increase bone mass in men with primary or hypogonadal osteoporosis at high fracture risk, and for glucocorticoid-associated osteoporosis at high fracture risk. The osteosarcoma warning describes increased osteosarcoma in rats (incidence reached 40% to 50% in high-dose groups), postmarketing human reports, no increased risk in observational studies, and limited long-term data, and says to avoid use with open epiphyses (pediatric and young adult patients), Paget's disease, bone metastases or skeletal malignancy, prior skeletal radiation, or hereditary osteosarcoma risk. FORTEO is not approved in pediatric patients. Bioavailability is about 95%, serum levels peak about 30 minutes after a 20 mcg dose and become non-quantifiable within 3 hours, and serum half-life is about 1 hour. The label's initial US approval year of 1987 refers to an earlier teriparatide product, not FORTEO.

Participants / model
Adults with osteoporosis at high fracture risk; label PK participants; rats for carcinogenicity
Treatment
FORTEO prefilled pen, subcutaneous
Follow-up
Label version effective 3 August 2026
Study design
FDA prescribing information
Funding
not stated in the source

The page gives no label dosing or duration-of-use details. FORTEO is not approved in pediatric patients.

Read the original source
Drugs@FDA: FORTEO approved 26 November 2002, later teriparatide products to 2025

Regulatory record

U.S. Food and Drug Administration. Drugs@FDA application record for NDA 021318 (FORTEO), with related teriparatide applications NDA 211939, ANDA 208569, NDA 218771, ANDA 213641 and NDA 019498. Dates read from the openFDA Drugs@FDA records.

FDA approved FORTEO under NDA 021318 on 26 November 2002. Later teriparatide products include BONSITY (NDA 211939, 4 October 2019), a Teva generic (ANDA 208569, 16 November 2023), an Almaject product (NDA 218771, 4 June 2024) and an Amphastar generic (ANDA 213641, 12 December 2025). openFDA also lists PARATHAR, a discontinued teriparatide acetate injectable (NDA 019498), without an approval date.

Participants / model
Not a clinical population
Treatment
Drug applications
Follow-up
Approvals from 2002 to 2025
Study design
FDA application records
Funding
not stated in the source

These records give approval dates. The openFDA record for PARATHAR carries no dates, so no approval date is given for it.

Read the original source
PubChem CID 16133850: C181H291N55O51S2, about 4118 g/mol

Chemical identity record

National Center for Biotechnology Information. PubChem Compound Summary for CID 16133850, teriparatide.

Teriparatide is recombinant or synthetic human PTH 1-34: PubChem CID 16133850, C181H291N55O51S2, 4118 g/mol, CAS 52232-67-4. The FORTEO label gives the same formula and a molecular weight of 4117.8 daltons. Products differ in how the peptide is made: FORTEO uses a modified strain of Escherichia coli, BONSITY uses Pseudomonas fluorescens, and the Teva product is made by chemical synthesis. A discontinued product, PARATHAR, was teriparatide acetate. Research-grade teriparatide acetate also appears in DailyMed as a bulk powder listing from Bachem, which is not a finished drug product.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined peptide; multiple manufacturing routes and one salt form
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

Identity record only; it says nothing about efficacy or safety.

Read the original source

What did the fracture trials find?

In 1,637 postmenopausal women with prior vertebral fractures, new vertebral fractures occurred in 14% on placebo versus 5% and 4% on teriparatide. In VERO, 1,360 women with severe osteoporosis had fewer new vertebral fractures on teriparatide than on risedronate, 5.4% versus 12.0%.

In 1,637 postmenopausal women with osteoporosis and prior vertebral fractures, randomized to daily subcutaneous PTH 1-34 at 20 or 40 mcg or placebo for a median observation of 21 months, new vertebral fractures occurred in 14% on placebo versus 5% and 4% (RR 0.35, 95% CI 0.22 to 0.55; RR 0.31, 95% CI 0.19 to 0.50). New nonvertebral fragility fractures occurred in 6% versus 3% in each active group (RR 0.47, 95% CI 0.25 to 0.88; RR 0.46, 95% CI 0.25 to 0.86). Lumbar spine BMD rose 9 and 13 percentage points more than placebo. The higher dose added side effects without more fracture benefit.

VERO randomized 1,360 postmenopausal women with severe osteoporosis to teriparatide 20 mcg daily or oral risedronate 35 mg weekly (double-dummy) for 24 months. New vertebral fractures occurred in 28 (5.4%) versus 64 (12.0%) of 680 per group (RR 0.44, 95% CI 0.29 to 0.68), and clinical fractures in 30 (4.8%) versus 61 (9.8%) (HR 0.48, 95% CI 0.32 to 0.74). Nonvertebral fragility fractures did not differ significantly (4.0% versus 6.1%; HR 0.66, 95% CI 0.39 to 1.10). Lilly funded VERO, which is registered as NCT01709110.

Both trials enrolled postmenopausal women with osteoporosis. The results do not apply to children or to people without osteoporosis.

Fracture trial: 1,637 women, vertebral fractures 14% versus 5% and 4%

Randomized controlled trial

Neer RM et al. N Engl J Med. 2001;344(19):1434-41. PMID 11346808.

New vertebral fractures occurred in 14% on placebo versus 5% and 4% on teriparatide (RR 0.35, 95% CI 0.22 to 0.55; RR 0.31, 95% CI 0.19 to 0.50). New nonvertebral fragility fractures occurred in 6% versus 3% in each active group (RR 0.47, 95% CI 0.25 to 0.88; RR 0.46, 95% CI 0.25 to 0.86). Lumbar spine BMD rose 9 and 13 percentage points more than placebo. The higher dose added side effects without more fracture benefit.

Participants / model
1,637 postmenopausal women with osteoporosis and prior vertebral fractures
Treatment
Daily subcutaneous PTH 1-34 (teriparatide) 20 or 40 mcg, or placebo
Follow-up
Median observation 21 months
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Endpoints were new vertebral and nonvertebral fractures and BMD. The result applies to postmenopausal women with prior vertebral fractures.

Read the original source
VERO: 1,360 women, vertebral fractures 5.4% versus 12.0%

Randomized controlled trial

Kendler DL et al. Lancet. 2018;391(10117):230-240. PMID 29129436.

New vertebral fractures occurred in 28 (5.4%) versus 64 (12.0%) of 680 per group (RR 0.44, 95% CI 0.29 to 0.68), and clinical fractures in 30 (4.8%) versus 61 (9.8%) (HR 0.48, 95% CI 0.32 to 0.74). Nonvertebral fragility fractures did not differ significantly (4.0% versus 6.1%; HR 0.66, 95% CI 0.39 to 1.10).

Participants / model
1,360 postmenopausal women with severe osteoporosis
Treatment
Subcutaneous teriparatide 20 mcg daily versus oral risedronate 35 mg weekly (double-dummy)
Follow-up
24 months
Study design
Randomized double-dummy active-comparator trial
Funding
Funded by Lilly

Endpoints were new vertebral, clinical and nonvertebral fractures.

Read the original source

Does teriparatide increase height in people with open growth plates?

No human study supports it. A PubMed search on 9 October 2026 returned 3 records and none tested teriparatide to increase height in healthy children or children with short stature, a registry query returned 0 studies, and the label says to avoid use with open epiphyses.

Supplier material notes the osteoporosis approval and describes off-label exploration of teriparatide in performance settings to increase height in people with open growth plates, with serious ethical and safety concerns.

A PubMed search on 9 October 2026 for teriparatide with child or adolescent and height, linear growth, short stature, growth plate or epiphysis terms returned 3 records: a hypophosphatasia review, a hypoparathyroidism replacement study and a study of PTH resistance in GNAS mutation carriers. None tested teriparatide to increase height in healthy children or children with short stature. A ClinicalTrials.gov query the same day for teriparatide as the intervention with short stature as the condition returned 0 studies.

The height use has no human trial behind it. Open epiphyses are the first item on the label's avoid-use list, so the claimed use targets the population the label singles out to exclude. FORTEO is not approved in pediatric patients.

PubMed search, 9 October 2026: 3 records, none testing height; registry search: 0 studies

PubMed search record

PubMed search run on 9 October 2026: teriparatide[tiab] AND (child[mh] OR adolescent[mh]) AND (height[tiab] OR linear growth[tiab] OR short stature[tiab] OR growth plate[tiab] OR epiphyses[tiab]). 3 records returned. A ClinicalTrials.gov query the same day for teriparatide as intervention with short stature as condition returned 0 studies.

The PubMed search returned 3 records: a hypophosphatasia review, the hypoparathyroidism replacement study, and a study of PTH resistance in GNAS mutation carriers. None tested teriparatide to increase height in healthy children or children with short stature. The ClinicalTrials.gov query returned 0 studies. The height use has no human trial behind it, and the label says to avoid open epiphyses.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Searches run on 9 October 2026
Study design
Literature and registry search
Funding
not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study exists.

Read the original source
FORTEO label, version effective 3 August 2026: indications, osteosarcoma warning, PK

FDA prescribing information

DailyMed, U.S. National Library of Medicine. FORTEO (teriparatide injection) prefilled pen, subcutaneous, prescribing information, label version effective 3 August 2026. Set ID aae667c5-381f-4f92-93df-2ed6158d07b0.

FORTEO, a PTH 1-34 analog, is labeled for postmenopausal women with osteoporosis at high fracture risk (where it reduces vertebral and nonvertebral fractures), to increase bone mass in men with primary or hypogonadal osteoporosis at high fracture risk, and for glucocorticoid-associated osteoporosis at high fracture risk. The osteosarcoma warning describes increased osteosarcoma in rats (incidence reached 40% to 50% in high-dose groups), postmarketing human reports, no increased risk in observational studies, and limited long-term data, and says to avoid use with open epiphyses (pediatric and young adult patients), Paget's disease, bone metastases or skeletal malignancy, prior skeletal radiation, or hereditary osteosarcoma risk. FORTEO is not approved in pediatric patients. Bioavailability is about 95%, serum levels peak about 30 minutes after a 20 mcg dose and become non-quantifiable within 3 hours, and serum half-life is about 1 hour. The label's initial US approval year of 1987 refers to an earlier teriparatide product, not FORTEO.

Participants / model
Adults with osteoporosis at high fracture risk; label PK participants; rats for carcinogenicity
Treatment
FORTEO prefilled pen, subcutaneous
Follow-up
Label version effective 3 August 2026
Study design
FDA prescribing information
Funding
not stated in the source

The page gives no label dosing or duration-of-use details. FORTEO is not approved in pediatric patients.

Read the original source
FORTEO 2002 label: boxed osteosarcoma warning and rat carcinogenicity studies

FDA prescribing information

U.S. Food and Drug Administration. FORTEO (teriparatide injection) prescribing information, 2002 version, NDA 021318. Drugs@FDA label file 21318_forteo_lbl.pdf.

The original label carried a boxed warning that teriparatide increased osteosarcoma in male and female rats in a dose- and duration-dependent way at systemic exposures 3 to 60 times the human exposure, that relevance to humans was uncertain, and that it should not be prescribed for patients at increased baseline osteosarcoma risk, including those with open epiphyses. It also limited the duration of use. The rat studies dosed Fischer 344 rats with 5, 30 or 75 mcg/kg/day for 24 months from 2 months of age; tumors were not detected in mature rats started at 6 months on 5 mcg/kg/day for 6 or 20 months.

Participants / model
Fischer 344 rats; human prescribing population
Treatment
FORTEO subcutaneous injection; daily subcutaneous dosing in rats
Follow-up
2002 label version; rat studies of 24 months, 6 months and 20 months
Study design
FDA prescribing information (2002 version)
Funding
not stated in the source

This is the historical label. The boxed warning was removed in 2020.

Read the original source

What do the rat and pediatric studies show about growth?

The only growth-plate stimulation found is in young rats at a dose far above the human dose. In 14 children with hypoparathyroidism given PTH 1-34 for years, height velocity was normal, not increased.

In young (6-week-old) male Sprague-Dawley rats, human PTH 1-34 at 80 mcg/kg/day, 5 days a week for 3 weeks, increased tibial growth plate thickness, chondrocyte number and longitudinal growth rate. The effect was not seen in adult (15-week-old) rats. There were 6 rats per group. This is the only growth-plate stimulation study located, and it is rat data at a dose far above the human daily dose.

In 14 children with hypoparathyroidism from APS1 or a calcium-receptor mutation (ages 7 to 16 at entry), treated with twice- or thrice-daily subcutaneous PTH 1-34 at a mean 0.75 (SD 0.15) mcg/kg/day for a mean 6.9 (SD 3.1) years, mean height velocity was normal throughout, not increased. Nephrocalcinosis progressed in 5 of 12 children with repeat imaging.

That series is hormone replacement in a deficiency state, not height enhancement, so it does not show an effect in healthy children.

Rat growth plate: thicker in 6-week-old rats, no effect in 15-week-old rats

Animal study

Ogawa T et al. J Bone Miner Metab. 2002;20(2):83-90. PMID 11862529.

Human PTH 1-34 increased tibial growth plate thickness, chondrocyte number and longitudinal growth rate in young (6-week-old) male rats; the effect was not seen in adult (15-week-old) rats.

Participants / model
Male Sprague-Dawley rats, 6 and 15 weeks old, n = 6 per group
Treatment
Systemic PTH 1-34 injections at 80 mcg/kg/day, 5 days a week
Follow-up
3 weeks
Study design
Original animal study
Funding
not stated in the source

This is the only growth-plate stimulation study located. It is rat data at a dose far above the human daily dose.

Read the original source
14 children with hypoparathyroidism: normal height velocity, not increased

Human study

Winer KK et al. J Pediatr. 2018;203:391-399.e1. PMID 30470382.

Mean height velocity was normal throughout, not increased. Nephrocalcinosis progressed in 5 of 12 children with repeat imaging.

Participants / model
14 children with hypoparathyroidism from APS1 or calcium-receptor mutation, ages 7 to 16 at entry
Treatment
Subcutaneous PTH 1-34, twice or thrice daily, mean 0.75 (SD 0.15) mcg/kg/day
Follow-up
Mean 6.9 (SD 3.1) years
Study design
Original long-term observational study
Funding
not stated in the source

This is hormone replacement in a deficiency state, not height enhancement. Endpoints were height velocity, bone accrual, and renal and mineral measures.

Read the original source

How does teriparatide work, and what does the body do with it?

Teriparatide is a PTH 1-34 analog. After a 20 mcg subcutaneous dose, serum levels peak about 30 minutes later and become non-quantifiable within 3 hours, and the serum half-life is about 1 hour.

The FORTEO label describes teriparatide as a PTH 1-34 analog. Bioavailability is about 95%. After a 20 mcg subcutaneous dose, serum levels peak about 30 minutes later and become non-quantifiable within 3 hours, and serum half-life is about 1 hour.

The sources reviewed do not describe the mechanism of bone effect in more detail. The only mechanistic growth finding is the young-rat growth-plate study, which does not transfer to people.

FORTEO label, version effective 3 August 2026: indications, osteosarcoma warning, PK

FDA prescribing information

DailyMed, U.S. National Library of Medicine. FORTEO (teriparatide injection) prefilled pen, subcutaneous, prescribing information, label version effective 3 August 2026. Set ID aae667c5-381f-4f92-93df-2ed6158d07b0.

FORTEO, a PTH 1-34 analog, is labeled for postmenopausal women with osteoporosis at high fracture risk (where it reduces vertebral and nonvertebral fractures), to increase bone mass in men with primary or hypogonadal osteoporosis at high fracture risk, and for glucocorticoid-associated osteoporosis at high fracture risk. The osteosarcoma warning describes increased osteosarcoma in rats (incidence reached 40% to 50% in high-dose groups), postmarketing human reports, no increased risk in observational studies, and limited long-term data, and says to avoid use with open epiphyses (pediatric and young adult patients), Paget's disease, bone metastases or skeletal malignancy, prior skeletal radiation, or hereditary osteosarcoma risk. FORTEO is not approved in pediatric patients. Bioavailability is about 95%, serum levels peak about 30 minutes after a 20 mcg dose and become non-quantifiable within 3 hours, and serum half-life is about 1 hour. The label's initial US approval year of 1987 refers to an earlier teriparatide product, not FORTEO.

Participants / model
Adults with osteoporosis at high fracture risk; label PK participants; rats for carcinogenicity
Treatment
FORTEO prefilled pen, subcutaneous
Follow-up
Label version effective 3 August 2026
Study design
FDA prescribing information
Funding
not stated in the source

The page gives no label dosing or duration-of-use details. FORTEO is not approved in pediatric patients.

Read the original source
PubChem CID 16133850: C181H291N55O51S2, about 4118 g/mol

Chemical identity record

National Center for Biotechnology Information. PubChem Compound Summary for CID 16133850, teriparatide.

Teriparatide is recombinant or synthetic human PTH 1-34: PubChem CID 16133850, C181H291N55O51S2, 4118 g/mol, CAS 52232-67-4. The FORTEO label gives the same formula and a molecular weight of 4117.8 daltons. Products differ in how the peptide is made: FORTEO uses a modified strain of Escherichia coli, BONSITY uses Pseudomonas fluorescens, and the Teva product is made by chemical synthesis. A discontinued product, PARATHAR, was teriparatide acetate. Research-grade teriparatide acetate also appears in DailyMed as a bulk powder listing from Bachem, which is not a finished drug product.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined peptide; multiple manufacturing routes and one salt form
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

Identity record only; it says nothing about efficacy or safety.

Read the original source
Rat growth plate: thicker in 6-week-old rats, no effect in 15-week-old rats

Animal study

Ogawa T et al. J Bone Miner Metab. 2002;20(2):83-90. PMID 11862529.

Human PTH 1-34 increased tibial growth plate thickness, chondrocyte number and longitudinal growth rate in young (6-week-old) male rats; the effect was not seen in adult (15-week-old) rats.

Participants / model
Male Sprague-Dawley rats, 6 and 15 weeks old, n = 6 per group
Treatment
Systemic PTH 1-34 injections at 80 mcg/kg/day, 5 days a week
Follow-up
3 weeks
Study design
Original animal study
Funding
not stated in the source

This is the only growth-plate stimulation study located. It is rat data at a dose far above the human daily dose.

Read the original source

What risks and warnings does the label carry?

The label warns about osteosarcoma, seen in rats at high doses, and says to avoid use with open epiphyses, Paget's disease, bone metastases or skeletal malignancy, prior skeletal radiation, or hereditary osteosarcoma risk. A hypercalcemia warning includes cutaneous calcification and calciphylaxis.

The FORTEO osteosarcoma warning describes increased osteosarcoma in rats (incidence reached 40% to 50% in high-dose groups), postmarketing human reports, no increased risk in observational studies, and limited long-term data. It says to avoid use with open epiphyses (pediatric and young adult patients), Paget's disease, bone metastases or skeletal malignancy, prior skeletal radiation, or hereditary osteosarcoma risk.

The 2020 labeling change also added cutaneous calcification, including calciphylaxis, to the hypercalcemia warning. In the 1,637-woman fracture trial, the higher dose added side effects without more fracture benefit. In the pediatric hypoparathyroidism series, nephrocalcinosis progressed in 5 of 12 children with repeat imaging.

FORTEO is not approved in pediatric patients. Incidence figures for other label adverse reactions are not given here.

FORTEO label, version effective 3 August 2026: indications, osteosarcoma warning, PK

FDA prescribing information

DailyMed, U.S. National Library of Medicine. FORTEO (teriparatide injection) prefilled pen, subcutaneous, prescribing information, label version effective 3 August 2026. Set ID aae667c5-381f-4f92-93df-2ed6158d07b0.

FORTEO, a PTH 1-34 analog, is labeled for postmenopausal women with osteoporosis at high fracture risk (where it reduces vertebral and nonvertebral fractures), to increase bone mass in men with primary or hypogonadal osteoporosis at high fracture risk, and for glucocorticoid-associated osteoporosis at high fracture risk. The osteosarcoma warning describes increased osteosarcoma in rats (incidence reached 40% to 50% in high-dose groups), postmarketing human reports, no increased risk in observational studies, and limited long-term data, and says to avoid use with open epiphyses (pediatric and young adult patients), Paget's disease, bone metastases or skeletal malignancy, prior skeletal radiation, or hereditary osteosarcoma risk. FORTEO is not approved in pediatric patients. Bioavailability is about 95%, serum levels peak about 30 minutes after a 20 mcg dose and become non-quantifiable within 3 hours, and serum half-life is about 1 hour. The label's initial US approval year of 1987 refers to an earlier teriparatide product, not FORTEO.

Participants / model
Adults with osteoporosis at high fracture risk; label PK participants; rats for carcinogenicity
Treatment
FORTEO prefilled pen, subcutaneous
Follow-up
Label version effective 3 August 2026
Study design
FDA prescribing information
Funding
not stated in the source

The page gives no label dosing or duration-of-use details. FORTEO is not approved in pediatric patients.

Read the original source
FDA letter, 16 November 2020: osteosarcoma boxed warning removed

Regulatory record

U.S. Food and Drug Administration. Approval letter for NDA 021318/S-054, dated 16 November 2020 in the openFDA record. Drugs@FDA letter file 021318Orig1s054ltr.pdf.

The approval letter, dated 16 November 2020 in the openFDA record, approved removal of the boxed warning on osteosarcoma, a change to the duration-of-treatment section allowing longer treatment in patients who remain at or return to high fracture risk, addition of cutaneous calcification including calciphylaxis to the hypercalcemia warning, and postmarketing labeling reflecting the long-term osteosarcoma surveillance studies.

Participants / model
Not a clinical population
Treatment
FORTEO subcutaneous injection
Follow-up
Labeling change dated 16 November 2020
Study design
FDA approval letter
Funding
not stated in the source

The letter records the labeling change. Safety evidence comes from the surveillance studies it cites.

Read the original source
Fracture trial: 1,637 women, vertebral fractures 14% versus 5% and 4%

Randomized controlled trial

Neer RM et al. N Engl J Med. 2001;344(19):1434-41. PMID 11346808.

New vertebral fractures occurred in 14% on placebo versus 5% and 4% on teriparatide (RR 0.35, 95% CI 0.22 to 0.55; RR 0.31, 95% CI 0.19 to 0.50). New nonvertebral fragility fractures occurred in 6% versus 3% in each active group (RR 0.47, 95% CI 0.25 to 0.88; RR 0.46, 95% CI 0.25 to 0.86). Lumbar spine BMD rose 9 and 13 percentage points more than placebo. The higher dose added side effects without more fracture benefit.

Participants / model
1,637 postmenopausal women with osteoporosis and prior vertebral fractures
Treatment
Daily subcutaneous PTH 1-34 (teriparatide) 20 or 40 mcg, or placebo
Follow-up
Median observation 21 months
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Endpoints were new vertebral and nonvertebral fractures and BMD. The result applies to postmenopausal women with prior vertebral fractures.

Read the original source
14 children with hypoparathyroidism: normal height velocity, not increased

Human study

Winer KK et al. J Pediatr. 2018;203:391-399.e1. PMID 30470382.

Mean height velocity was normal throughout, not increased. Nephrocalcinosis progressed in 5 of 12 children with repeat imaging.

Participants / model
14 children with hypoparathyroidism from APS1 or calcium-receptor mutation, ages 7 to 16 at entry
Treatment
Subcutaneous PTH 1-34, twice or thrice daily, mean 0.75 (SD 0.15) mcg/kg/day
Follow-up
Mean 6.9 (SD 3.1) years
Study design
Original long-term observational study
Funding
not stated in the source

This is hormone replacement in a deficiency state, not height enhancement. Endpoints were height velocity, bone accrual, and renal and mineral measures.

Read the original source

What is the osteosarcoma record for teriparatide?

Rats developed osteosarcoma at high exposures, and FORTEO carried a boxed warning from 2002 until FDA approved its removal in a letter dated 16 November 2020. Human surveillance estimates are close to no increase but imprecise, with 3 observed cases in each analysis.

The original 2002 FORTEO label carried a boxed warning that teriparatide increased osteosarcoma in male and female rats in a dose- and duration-dependent way at systemic exposures 3 to 60 times the human exposure. The label said relevance to humans was uncertain, that it should not be prescribed for patients at increased baseline osteosarcoma risk, including those with open epiphyses, and it limited the duration of use. The rat studies dosed Fischer 344 rats with 5, 30 or 75 mcg/kg/day for 24 months from 2 months of age. Tumors were not detected in mature rats started at 6 months on 5 mcg/kg/day for 6 or 20 months.

FDA's approval letter for NDA 021318/S-054, dated 16 November 2020 in the openFDA record, approved removal of the boxed warning, a change allowing longer treatment in patients who remain at or return to high fracture risk, and postmarketing labeling reflecting the long-term osteosarcoma surveillance studies.

A US surveillance study of osteosarcoma cases diagnosed from 2003 to 2016 completed interviews with 1,173 patients (24% of cases) and found three with prior teriparatide use against 4.17 expected, a standardized incidence ratio of 0.72 (90% CI 0.20 to 1.86). Background osteosarcoma incidence in US adults 40 and older is about 2.5 cases per million per year, so the estimate is imprecise. Lilly funded the study.

A pharmacy and state cancer registry linkage study found 18 osteosarcoma cases across four cohorts, the same 3 cases in the two teriparatide cohorts. Incidence rate ratios against unexposed osteoporosis and general-population cohorts were 1.0 (95% CI 0.2 to 4.5) and 1.3 (95% CI 0.2 to 5.1), or 0.6 (95% CI 0.1 to 3.6) and 0.8 (95% CI 0.1 to 4.0) when restricted to states with participating registries. The authors call the estimates imprecise. Lilly and IQVIA conducted the study, and it supported the 2020 label change.

FORTEO 2002 label: boxed osteosarcoma warning and rat carcinogenicity studies

FDA prescribing information

U.S. Food and Drug Administration. FORTEO (teriparatide injection) prescribing information, 2002 version, NDA 021318. Drugs@FDA label file 21318_forteo_lbl.pdf.

The original label carried a boxed warning that teriparatide increased osteosarcoma in male and female rats in a dose- and duration-dependent way at systemic exposures 3 to 60 times the human exposure, that relevance to humans was uncertain, and that it should not be prescribed for patients at increased baseline osteosarcoma risk, including those with open epiphyses. It also limited the duration of use. The rat studies dosed Fischer 344 rats with 5, 30 or 75 mcg/kg/day for 24 months from 2 months of age; tumors were not detected in mature rats started at 6 months on 5 mcg/kg/day for 6 or 20 months.

Participants / model
Fischer 344 rats; human prescribing population
Treatment
FORTEO subcutaneous injection; daily subcutaneous dosing in rats
Follow-up
2002 label version; rat studies of 24 months, 6 months and 20 months
Study design
FDA prescribing information (2002 version)
Funding
not stated in the source

This is the historical label. The boxed warning was removed in 2020.

Read the original source
FDA letter, 16 November 2020: osteosarcoma boxed warning removed

Regulatory record

U.S. Food and Drug Administration. Approval letter for NDA 021318/S-054, dated 16 November 2020 in the openFDA record. Drugs@FDA letter file 021318Orig1s054ltr.pdf.

The approval letter, dated 16 November 2020 in the openFDA record, approved removal of the boxed warning on osteosarcoma, a change to the duration-of-treatment section allowing longer treatment in patients who remain at or return to high fracture risk, addition of cutaneous calcification including calciphylaxis to the hypercalcemia warning, and postmarketing labeling reflecting the long-term osteosarcoma surveillance studies.

Participants / model
Not a clinical population
Treatment
FORTEO subcutaneous injection
Follow-up
Labeling change dated 16 November 2020
Study design
FDA approval letter
Funding
not stated in the source

The letter records the labeling change. Safety evidence comes from the surveillance studies it cites.

Read the original source
Surveillance: 1,173 interviewed patients, 3 with teriparatide use, SIR 0.72

Human study

Gilsenan A et al. J Bone Miner Res. 2021;36(2):244-251. PMID 32990990.

The study completed interviews with 1,173 patients (24% of cases) and found three with prior teriparatide use against 4.17 expected, a standardized incidence ratio of 0.72 (90% CI 0.20 to 1.86). Background osteosarcoma incidence in US adults 40 and older is about 2.5 cases per million per year, so the estimate is imprecise.

Participants / model
Adults with osteosarcoma identified through US cancer registries
Treatment
Prior teriparatide use, self- or proxy-reported
Follow-up
Cases diagnosed 2003 to 2016
Study design
Original postmarketing surveillance study
Funding
Lilly-funded

The estimate is imprecise: three observed cases.

Read the original source
Registry linkage: 18 osteosarcoma cases in four cohorts, rate ratios near 1

Human study

Kellier-Steele N et al. Bone. 2022;160:116394. PMID 35318162.

The study found 18 osteosarcoma cases across four cohorts, the same 3 cases in the two teriparatide cohorts. Incidence rate ratios against unexposed osteoporosis and general-population cohorts were 1.0 (95% CI 0.2 to 4.5) and 1.3 (95% CI 0.2 to 5.1), or 0.6 (95% CI 0.1 to 3.6) and 0.8 (95% CI 0.1 to 4.0) when restricted to states with participating registries. The authors call the estimates imprecise; the study supported the 2020 label change.

Participants / model
Adults dispensed teriparatide and matched comparison cohorts in the US
Treatment
Teriparatide by pharmacy dispensing
Follow-up
not stated in the source
Study design
Original observational study
Funding
Lilly and IQVIA

The estimates are imprecise by the authors' own description.

Read the original source

Why does teriparatide sit in S tier?

FDA approval since 2002 for three osteoporosis indications, a 1,637-woman fracture trial, a 1,360-woman active-comparator trial and more than 20 years of postmarketing surveillance support the S. The grade covers osteoporosis, not the height claim, which no human study supports.

The S applies to the approved osteoporosis uses. The approved population is narrow, adults at high fracture risk, and the label still carries an osteosarcoma warning and an avoid-use list.

The height claim is separate and unsupported. The only growth-plate stimulation found was in young rats at a dose far above the human dose, and the single long-term pediatric series, which was hormone replacement in hypoparathyroidism, reported normal rather than increased height velocity.

FORTEO label, version effective 3 August 2026: indications, osteosarcoma warning, PK

FDA prescribing information

DailyMed, U.S. National Library of Medicine. FORTEO (teriparatide injection) prefilled pen, subcutaneous, prescribing information, label version effective 3 August 2026. Set ID aae667c5-381f-4f92-93df-2ed6158d07b0.

FORTEO, a PTH 1-34 analog, is labeled for postmenopausal women with osteoporosis at high fracture risk (where it reduces vertebral and nonvertebral fractures), to increase bone mass in men with primary or hypogonadal osteoporosis at high fracture risk, and for glucocorticoid-associated osteoporosis at high fracture risk. The osteosarcoma warning describes increased osteosarcoma in rats (incidence reached 40% to 50% in high-dose groups), postmarketing human reports, no increased risk in observational studies, and limited long-term data, and says to avoid use with open epiphyses (pediatric and young adult patients), Paget's disease, bone metastases or skeletal malignancy, prior skeletal radiation, or hereditary osteosarcoma risk. FORTEO is not approved in pediatric patients. Bioavailability is about 95%, serum levels peak about 30 minutes after a 20 mcg dose and become non-quantifiable within 3 hours, and serum half-life is about 1 hour. The label's initial US approval year of 1987 refers to an earlier teriparatide product, not FORTEO.

Participants / model
Adults with osteoporosis at high fracture risk; label PK participants; rats for carcinogenicity
Treatment
FORTEO prefilled pen, subcutaneous
Follow-up
Label version effective 3 August 2026
Study design
FDA prescribing information
Funding
not stated in the source

The page gives no label dosing or duration-of-use details. FORTEO is not approved in pediatric patients.

Read the original source
Drugs@FDA: FORTEO approved 26 November 2002, later teriparatide products to 2025

Regulatory record

U.S. Food and Drug Administration. Drugs@FDA application record for NDA 021318 (FORTEO), with related teriparatide applications NDA 211939, ANDA 208569, NDA 218771, ANDA 213641 and NDA 019498. Dates read from the openFDA Drugs@FDA records.

FDA approved FORTEO under NDA 021318 on 26 November 2002. Later teriparatide products include BONSITY (NDA 211939, 4 October 2019), a Teva generic (ANDA 208569, 16 November 2023), an Almaject product (NDA 218771, 4 June 2024) and an Amphastar generic (ANDA 213641, 12 December 2025). openFDA also lists PARATHAR, a discontinued teriparatide acetate injectable (NDA 019498), without an approval date.

Participants / model
Not a clinical population
Treatment
Drug applications
Follow-up
Approvals from 2002 to 2025
Study design
FDA application records
Funding
not stated in the source

These records give approval dates. The openFDA record for PARATHAR carries no dates, so no approval date is given for it.

Read the original source
Fracture trial: 1,637 women, vertebral fractures 14% versus 5% and 4%

Randomized controlled trial

Neer RM et al. N Engl J Med. 2001;344(19):1434-41. PMID 11346808.

New vertebral fractures occurred in 14% on placebo versus 5% and 4% on teriparatide (RR 0.35, 95% CI 0.22 to 0.55; RR 0.31, 95% CI 0.19 to 0.50). New nonvertebral fragility fractures occurred in 6% versus 3% in each active group (RR 0.47, 95% CI 0.25 to 0.88; RR 0.46, 95% CI 0.25 to 0.86). Lumbar spine BMD rose 9 and 13 percentage points more than placebo. The higher dose added side effects without more fracture benefit.

Participants / model
1,637 postmenopausal women with osteoporosis and prior vertebral fractures
Treatment
Daily subcutaneous PTH 1-34 (teriparatide) 20 or 40 mcg, or placebo
Follow-up
Median observation 21 months
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Endpoints were new vertebral and nonvertebral fractures and BMD. The result applies to postmenopausal women with prior vertebral fractures.

Read the original source
VERO: 1,360 women, vertebral fractures 5.4% versus 12.0%

Randomized controlled trial

Kendler DL et al. Lancet. 2018;391(10117):230-240. PMID 29129436.

New vertebral fractures occurred in 28 (5.4%) versus 64 (12.0%) of 680 per group (RR 0.44, 95% CI 0.29 to 0.68), and clinical fractures in 30 (4.8%) versus 61 (9.8%) (HR 0.48, 95% CI 0.32 to 0.74). Nonvertebral fragility fractures did not differ significantly (4.0% versus 6.1%; HR 0.66, 95% CI 0.39 to 1.10).

Participants / model
1,360 postmenopausal women with severe osteoporosis
Treatment
Subcutaneous teriparatide 20 mcg daily versus oral risedronate 35 mg weekly (double-dummy)
Follow-up
24 months
Study design
Randomized double-dummy active-comparator trial
Funding
Funded by Lilly

Endpoints were new vertebral, clinical and nonvertebral fractures.

Read the original source
PubMed search, 9 October 2026: 3 records, none testing height; registry search: 0 studies

PubMed search record

PubMed search run on 9 October 2026: teriparatide[tiab] AND (child[mh] OR adolescent[mh]) AND (height[tiab] OR linear growth[tiab] OR short stature[tiab] OR growth plate[tiab] OR epiphyses[tiab]). 3 records returned. A ClinicalTrials.gov query the same day for teriparatide as intervention with short stature as condition returned 0 studies.

The PubMed search returned 3 records: a hypophosphatasia review, the hypoparathyroidism replacement study, and a study of PTH resistance in GNAS mutation carriers. None tested teriparatide to increase height in healthy children or children with short stature. The ClinicalTrials.gov query returned 0 studies. The height use has no human trial behind it, and the label says to avoid open epiphyses.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Searches run on 9 October 2026
Study design
Literature and registry search
Funding
not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study exists.

Read the original source
Rat growth plate: thicker in 6-week-old rats, no effect in 15-week-old rats

Animal study

Ogawa T et al. J Bone Miner Metab. 2002;20(2):83-90. PMID 11862529.

Human PTH 1-34 increased tibial growth plate thickness, chondrocyte number and longitudinal growth rate in young (6-week-old) male rats; the effect was not seen in adult (15-week-old) rats.

Participants / model
Male Sprague-Dawley rats, 6 and 15 weeks old, n = 6 per group
Treatment
Systemic PTH 1-34 injections at 80 mcg/kg/day, 5 days a week
Follow-up
3 weeks
Study design
Original animal study
Funding
not stated in the source

This is the only growth-plate stimulation study located. It is rat data at a dose far above the human daily dose.

Read the original source
14 children with hypoparathyroidism: normal height velocity, not increased

Human study

Winer KK et al. J Pediatr. 2018;203:391-399.e1. PMID 30470382.

Mean height velocity was normal throughout, not increased. Nephrocalcinosis progressed in 5 of 12 children with repeat imaging.

Participants / model
14 children with hypoparathyroidism from APS1 or calcium-receptor mutation, ages 7 to 16 at entry
Treatment
Subcutaneous PTH 1-34, twice or thrice daily, mean 0.75 (SD 0.15) mcg/kg/day
Follow-up
Mean 6.9 (SD 3.1) years
Study design
Original long-term observational study
Funding
not stated in the source

This is hormone replacement in a deficiency state, not height enhancement. Endpoints were height velocity, bone accrual, and renal and mineral measures.

Read the original source

Studies and sources

FORTEO label, version effective 3 August 2026: indications, osteosarcoma warning, PK

FDA prescribing information

DailyMed, U.S. National Library of Medicine. FORTEO (teriparatide injection) prefilled pen, subcutaneous, prescribing information, label version effective 3 August 2026. Set ID aae667c5-381f-4f92-93df-2ed6158d07b0.

FORTEO, a PTH 1-34 analog, is labeled for postmenopausal women with osteoporosis at high fracture risk (where it reduces vertebral and nonvertebral fractures), to increase bone mass in men with primary or hypogonadal osteoporosis at high fracture risk, and for glucocorticoid-associated osteoporosis at high fracture risk. The osteosarcoma warning describes increased osteosarcoma in rats (incidence reached 40% to 50% in high-dose groups), postmarketing human reports, no increased risk in observational studies, and limited long-term data, and says to avoid use with open epiphyses (pediatric and young adult patients), Paget's disease, bone metastases or skeletal malignancy, prior skeletal radiation, or hereditary osteosarcoma risk. FORTEO is not approved in pediatric patients. Bioavailability is about 95%, serum levels peak about 30 minutes after a 20 mcg dose and become non-quantifiable within 3 hours, and serum half-life is about 1 hour. The label's initial US approval year of 1987 refers to an earlier teriparatide product, not FORTEO.

Participants / model
Adults with osteoporosis at high fracture risk; label PK participants; rats for carcinogenicity
Treatment
FORTEO prefilled pen, subcutaneous
Follow-up
Label version effective 3 August 2026
Study design
FDA prescribing information
Funding
not stated in the source

The page gives no label dosing or duration-of-use details. FORTEO is not approved in pediatric patients.

Read the original source
Drugs@FDA: FORTEO approved 26 November 2002, later teriparatide products to 2025

Regulatory record

U.S. Food and Drug Administration. Drugs@FDA application record for NDA 021318 (FORTEO), with related teriparatide applications NDA 211939, ANDA 208569, NDA 218771, ANDA 213641 and NDA 019498. Dates read from the openFDA Drugs@FDA records.

FDA approved FORTEO under NDA 021318 on 26 November 2002. Later teriparatide products include BONSITY (NDA 211939, 4 October 2019), a Teva generic (ANDA 208569, 16 November 2023), an Almaject product (NDA 218771, 4 June 2024) and an Amphastar generic (ANDA 213641, 12 December 2025). openFDA also lists PARATHAR, a discontinued teriparatide acetate injectable (NDA 019498), without an approval date.

Participants / model
Not a clinical population
Treatment
Drug applications
Follow-up
Approvals from 2002 to 2025
Study design
FDA application records
Funding
not stated in the source

These records give approval dates. The openFDA record for PARATHAR carries no dates, so no approval date is given for it.

Read the original source
Fracture trial: 1,637 women, vertebral fractures 14% versus 5% and 4%

Randomized controlled trial

Neer RM et al. N Engl J Med. 2001;344(19):1434-41. PMID 11346808.

New vertebral fractures occurred in 14% on placebo versus 5% and 4% on teriparatide (RR 0.35, 95% CI 0.22 to 0.55; RR 0.31, 95% CI 0.19 to 0.50). New nonvertebral fragility fractures occurred in 6% versus 3% in each active group (RR 0.47, 95% CI 0.25 to 0.88; RR 0.46, 95% CI 0.25 to 0.86). Lumbar spine BMD rose 9 and 13 percentage points more than placebo. The higher dose added side effects without more fracture benefit.

Participants / model
1,637 postmenopausal women with osteoporosis and prior vertebral fractures
Treatment
Daily subcutaneous PTH 1-34 (teriparatide) 20 or 40 mcg, or placebo
Follow-up
Median observation 21 months
Study design
Randomized placebo-controlled trial
Funding
not stated in the source

Endpoints were new vertebral and nonvertebral fractures and BMD. The result applies to postmenopausal women with prior vertebral fractures.

Read the original source
VERO: 1,360 women, vertebral fractures 5.4% versus 12.0%

Randomized controlled trial

Kendler DL et al. Lancet. 2018;391(10117):230-240. PMID 29129436.

New vertebral fractures occurred in 28 (5.4%) versus 64 (12.0%) of 680 per group (RR 0.44, 95% CI 0.29 to 0.68), and clinical fractures in 30 (4.8%) versus 61 (9.8%) (HR 0.48, 95% CI 0.32 to 0.74). Nonvertebral fragility fractures did not differ significantly (4.0% versus 6.1%; HR 0.66, 95% CI 0.39 to 1.10).

Participants / model
1,360 postmenopausal women with severe osteoporosis
Treatment
Subcutaneous teriparatide 20 mcg daily versus oral risedronate 35 mg weekly (double-dummy)
Follow-up
24 months
Study design
Randomized double-dummy active-comparator trial
Funding
Funded by Lilly

Endpoints were new vertebral, clinical and nonvertebral fractures.

Read the original source
FORTEO 2002 label: boxed osteosarcoma warning and rat carcinogenicity studies

FDA prescribing information

U.S. Food and Drug Administration. FORTEO (teriparatide injection) prescribing information, 2002 version, NDA 021318. Drugs@FDA label file 21318_forteo_lbl.pdf.

The original label carried a boxed warning that teriparatide increased osteosarcoma in male and female rats in a dose- and duration-dependent way at systemic exposures 3 to 60 times the human exposure, that relevance to humans was uncertain, and that it should not be prescribed for patients at increased baseline osteosarcoma risk, including those with open epiphyses. It also limited the duration of use. The rat studies dosed Fischer 344 rats with 5, 30 or 75 mcg/kg/day for 24 months from 2 months of age; tumors were not detected in mature rats started at 6 months on 5 mcg/kg/day for 6 or 20 months.

Participants / model
Fischer 344 rats; human prescribing population
Treatment
FORTEO subcutaneous injection; daily subcutaneous dosing in rats
Follow-up
2002 label version; rat studies of 24 months, 6 months and 20 months
Study design
FDA prescribing information (2002 version)
Funding
not stated in the source

This is the historical label. The boxed warning was removed in 2020.

Read the original source
FDA letter, 16 November 2020: osteosarcoma boxed warning removed

Regulatory record

U.S. Food and Drug Administration. Approval letter for NDA 021318/S-054, dated 16 November 2020 in the openFDA record. Drugs@FDA letter file 021318Orig1s054ltr.pdf.

The approval letter, dated 16 November 2020 in the openFDA record, approved removal of the boxed warning on osteosarcoma, a change to the duration-of-treatment section allowing longer treatment in patients who remain at or return to high fracture risk, addition of cutaneous calcification including calciphylaxis to the hypercalcemia warning, and postmarketing labeling reflecting the long-term osteosarcoma surveillance studies.

Participants / model
Not a clinical population
Treatment
FORTEO subcutaneous injection
Follow-up
Labeling change dated 16 November 2020
Study design
FDA approval letter
Funding
not stated in the source

The letter records the labeling change. Safety evidence comes from the surveillance studies it cites.

Read the original source
Surveillance: 1,173 interviewed patients, 3 with teriparatide use, SIR 0.72

Human study

Gilsenan A et al. J Bone Miner Res. 2021;36(2):244-251. PMID 32990990.

The study completed interviews with 1,173 patients (24% of cases) and found three with prior teriparatide use against 4.17 expected, a standardized incidence ratio of 0.72 (90% CI 0.20 to 1.86). Background osteosarcoma incidence in US adults 40 and older is about 2.5 cases per million per year, so the estimate is imprecise.

Participants / model
Adults with osteosarcoma identified through US cancer registries
Treatment
Prior teriparatide use, self- or proxy-reported
Follow-up
Cases diagnosed 2003 to 2016
Study design
Original postmarketing surveillance study
Funding
Lilly-funded

The estimate is imprecise: three observed cases.

Read the original source
Registry linkage: 18 osteosarcoma cases in four cohorts, rate ratios near 1

Human study

Kellier-Steele N et al. Bone. 2022;160:116394. PMID 35318162.

The study found 18 osteosarcoma cases across four cohorts, the same 3 cases in the two teriparatide cohorts. Incidence rate ratios against unexposed osteoporosis and general-population cohorts were 1.0 (95% CI 0.2 to 4.5) and 1.3 (95% CI 0.2 to 5.1), or 0.6 (95% CI 0.1 to 3.6) and 0.8 (95% CI 0.1 to 4.0) when restricted to states with participating registries. The authors call the estimates imprecise; the study supported the 2020 label change.

Participants / model
Adults dispensed teriparatide and matched comparison cohorts in the US
Treatment
Teriparatide by pharmacy dispensing
Follow-up
not stated in the source
Study design
Original observational study
Funding
Lilly and IQVIA

The estimates are imprecise by the authors' own description.

Read the original source
14 children with hypoparathyroidism: normal height velocity, not increased

Human study

Winer KK et al. J Pediatr. 2018;203:391-399.e1. PMID 30470382.

Mean height velocity was normal throughout, not increased. Nephrocalcinosis progressed in 5 of 12 children with repeat imaging.

Participants / model
14 children with hypoparathyroidism from APS1 or calcium-receptor mutation, ages 7 to 16 at entry
Treatment
Subcutaneous PTH 1-34, twice or thrice daily, mean 0.75 (SD 0.15) mcg/kg/day
Follow-up
Mean 6.9 (SD 3.1) years
Study design
Original long-term observational study
Funding
not stated in the source

This is hormone replacement in a deficiency state, not height enhancement. Endpoints were height velocity, bone accrual, and renal and mineral measures.

Read the original source
Rat growth plate: thicker in 6-week-old rats, no effect in 15-week-old rats

Animal study

Ogawa T et al. J Bone Miner Metab. 2002;20(2):83-90. PMID 11862529.

Human PTH 1-34 increased tibial growth plate thickness, chondrocyte number and longitudinal growth rate in young (6-week-old) male rats; the effect was not seen in adult (15-week-old) rats.

Participants / model
Male Sprague-Dawley rats, 6 and 15 weeks old, n = 6 per group
Treatment
Systemic PTH 1-34 injections at 80 mcg/kg/day, 5 days a week
Follow-up
3 weeks
Study design
Original animal study
Funding
not stated in the source

This is the only growth-plate stimulation study located. It is rat data at a dose far above the human daily dose.

Read the original source
PubChem CID 16133850: C181H291N55O51S2, about 4118 g/mol

Chemical identity record

National Center for Biotechnology Information. PubChem Compound Summary for CID 16133850, teriparatide.

Teriparatide is recombinant or synthetic human PTH 1-34: PubChem CID 16133850, C181H291N55O51S2, 4118 g/mol, CAS 52232-67-4. The FORTEO label gives the same formula and a molecular weight of 4117.8 daltons. Products differ in how the peptide is made: FORTEO uses a modified strain of Escherichia coli, BONSITY uses Pseudomonas fluorescens, and the Teva product is made by chemical synthesis. A discontinued product, PARATHAR, was teriparatide acetate. Research-grade teriparatide acetate also appears in DailyMed as a bulk powder listing from Bachem, which is not a finished drug product.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined peptide; multiple manufacturing routes and one salt form
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

Identity record only; it says nothing about efficacy or safety.

Read the original source

Why is Teriparatide in S tier?

S fits an approved medicine with FDA approval since 2002, three labeled osteoporosis indications, a 1,637-woman fracture trial, a 1,360-woman active-comparator trial and more than 20 years of postmarketing surveillance. The grade covers the approved osteoporosis uses in adults at high fracture risk, a narrow population with an osteosarcoma warning and an avoid-use list on the label. It does not cover the height claim, which no human study supports.