Abaloparatide
updated
Abaloparatide is a daily bone-building medicine for adults with osteoporosis at high fracture risk. The fracture-reduction trial enrolled postmenopausal women; the pivotal trial in men measured bone density only. The label recommends no more than two years of lifetime use, and ACTIVExtend used alendronate afterward.
PTHrP analog and PTH1 receptor agonist
- Synthetic 34-amino-acid PTHrP analog
- 80 mcg subcutaneous injection once daily
- US approval began in 2017
Is the question about fractures, bone density, or height?
ACTIVE measured fractures and bone density in postmenopausal women. ATOM measured 12-month bone-density change in men. Neither trial measured adult height.
| Question | Population and study | What the evidence answers |
|---|---|---|
| Does it reduce fractures? | Postmenopausal women in ACTIVE | Yes, for new vertebral and nonvertebral fractures over 18 months |
| Does it increase BMD? | Women in ACTIVE and men in ATOM | Yes, at the lumbar spine, total hip, and femoral neck |
| Does it make adults taller? | No adult-height trial | No supporting clinical endpoint or labeled indication |
TYMLOS label · August 2026
FDA prescribing information
Radius Health. TYMLOS (abaloparatide) prescribing information. Revised August 2026.
Defines the sex-specific osteoporosis indications, 80 mcg daily regimen, two-year lifetime recommendation, pivotal outcome tables, mechanism, adverse reactions, and osteosarcoma precautions.
- Participants / model
- Postmenopausal women and men with osteoporosis at high fracture risk under the labeled criteria
- Treatment
- TYMLOS 80 mcg subcutaneously once daily
- Follow-up
- Current label revised August 2026; clinical trials ran 18 months in women and 12 months in men
- Study design
- Regulatory prescribing information
The male indication is to increase bone density. The women's indication includes vertebral and nonvertebral fracture reduction.
Read the original sourceACTIVE · JAMA 2016
Randomized controlled trial
Miller PD et al. JAMA. 2016;316(7):722-733. doi:10.1001/jama.2016.11136. PMID: 27533157.
Among 2,463 randomized women, abaloparatide reduced new vertebral and nonvertebral fractures versus placebo and increased BMD over 18 months.
- Participants / model
- Postmenopausal women with osteoporosis
- Treatment
- Abaloparatide 80 mcg daily versus placebo; open-label teriparatide was an additional arm
- Follow-up
- 18 months, with nonvertebral follow-up through 19 months
- Study design
- Phase 3 multicenter randomized double-blind placebo-controlled trial with an open-label active comparator arm
- Funding
- Radius Health
The vertebral analysis used evaluable radiographs and smaller denominators than the randomized population. The article reported funding and author relationships with the sponsor.
Read the original sourceATOM · JBMR 2022
Randomized controlled trial
Czerwinski E et al. Journal of Bone and Mineral Research. 2022;37(12):2435-2442. doi:10.1002/jbmr.4719. PMID: 36190391.
In 228 men, abaloparatide produced larger 12-month BMD gains than placebo at the lumbar spine, total hip, and femoral neck.
- Participants / model
- Men aged 42 to 85 years with osteoporosis
- Treatment
- Abaloparatide 80 mcg daily versus placebo, randomized 2:1
- Follow-up
- 12 months
- Study design
- Phase 3 randomized double-blind placebo-controlled trial; primary endpoint was lumbar-spine BMD
- Funding
- Radius Health; sponsor employees were authors
The study established BMD effects and was not a fracture-outcome trial.
Read the original sourceWho does the current US label actually cover?
The label covers postmenopausal women and men with osteoporosis who are at high fracture risk, or who failed or could not tolerate another available osteoporosis therapy. Its wording differs by sex: it says abaloparatide reduces vertebral and nonvertebral fracture risk in postmenopausal women, while the male indication is to increase bone density.
The label defines high fracture risk through a history of osteoporotic fracture or multiple fracture-risk factors. It also covers patients who failed or could not tolerate another available osteoporosis therapy.
TYMLOS label · August 2026
FDA prescribing information
Radius Health. TYMLOS (abaloparatide) prescribing information. Revised August 2026.
Defines the sex-specific osteoporosis indications, 80 mcg daily regimen, two-year lifetime recommendation, pivotal outcome tables, mechanism, adverse reactions, and osteosarcoma precautions.
- Participants / model
- Postmenopausal women and men with osteoporosis at high fracture risk under the labeled criteria
- Treatment
- TYMLOS 80 mcg subcutaneously once daily
- Follow-up
- Current label revised August 2026; clinical trials ran 18 months in women and 12 months in men
- Study design
- Regulatory prescribing information
The male indication is to increase bone density. The women's indication includes vertebral and nonvertebral fracture reduction.
Read the original sourceHow large was the fracture result in postmenopausal women?
ACTIVE randomized 2,463 postmenopausal women with osteoporosis to abaloparatide, placebo, or open-label teriparatide for 18 months. In the label's modified intent-to-treat radiograph set, new vertebral fractures occurred in 0.6% of women assigned abaloparatide and 4.2% assigned placebo. That is a 3.6 percentage-point absolute difference and an 86% relative reduction. Nonvertebral fractures occurred in 2.7% and 4.7%, respectively, through 19 months, a 2.0-point absolute difference and a 43% relative reduction.
| Endpoint | Abaloparatide | Placebo | Difference |
|---|---|---|---|
| New vertebral fracture at 18 months | 0.6% of 690 evaluable women | 4.2% of 711 | 3.6 percentage points; 86% relative reduction |
| Nonvertebral fracture through 19 months | 2.7% | 4.7% | 2.0 percentage points; 43% relative reduction |
The published trial included a teriparatide arm, but it was open-label and the primary abaloparatide efficacy comparisons were against placebo.
ACTIVE · JAMA 2016
Randomized controlled trial
Miller PD et al. JAMA. 2016;316(7):722-733. doi:10.1001/jama.2016.11136. PMID: 27533157.
Among 2,463 randomized women, abaloparatide reduced new vertebral and nonvertebral fractures versus placebo and increased BMD over 18 months.
- Participants / model
- Postmenopausal women with osteoporosis
- Treatment
- Abaloparatide 80 mcg daily versus placebo; open-label teriparatide was an additional arm
- Follow-up
- 18 months, with nonvertebral follow-up through 19 months
- Study design
- Phase 3 multicenter randomized double-blind placebo-controlled trial with an open-label active comparator arm
- Funding
- Radius Health
The vertebral analysis used evaluable radiographs and smaller denominators than the randomized population. The article reported funding and author relationships with the sponsor.
Read the original sourceTYMLOS label · August 2026
FDA prescribing information
Radius Health. TYMLOS (abaloparatide) prescribing information. Revised August 2026.
Defines the sex-specific osteoporosis indications, 80 mcg daily regimen, two-year lifetime recommendation, pivotal outcome tables, mechanism, adverse reactions, and osteosarcoma precautions.
- Participants / model
- Postmenopausal women and men with osteoporosis at high fracture risk under the labeled criteria
- Treatment
- TYMLOS 80 mcg subcutaneously once daily
- Follow-up
- Current label revised August 2026; clinical trials ran 18 months in women and 12 months in men
- Study design
- Regulatory prescribing information
The male indication is to increase bone density. The women's indication includes vertebral and nonvertebral fracture reduction.
Read the original sourceWhat did the bone-density studies show in women and men?
Bone density and fractures are separate endpoints. At 18 months in ACTIVE, lumbar-spine BMD changed by 9.2% with abaloparatide and 0.5% with placebo; total-hip BMD by 3.4% and -0.1%; and femoral-neck BMD by 2.9% and -0.4%. In ATOM, 228 men aged 42 to 85 were randomized 2:1 for 12 months. Lumbar-spine BMD changed by 8.48% versus 1.17%, total hip by 2.14% versus 0.01%, and femoral neck by 2.98% versus 0.15%.
| Population | Lumbar spine | Total hip | Femoral neck |
|---|---|---|---|
| Women, 18 months | 9.2% vs 0.5% | 3.4% vs -0.1% | 2.9% vs -0.4% |
| Men, 12 months | 8.48% vs 1.17% | 2.14% vs 0.01% | 2.98% vs 0.15% |
Each row compares abaloparatide with placebo. ATOM's primary endpoint was lumbar-spine BMD; it was not designed to establish fracture reduction in men.
TYMLOS label · August 2026
FDA prescribing information
Radius Health. TYMLOS (abaloparatide) prescribing information. Revised August 2026.
Defines the sex-specific osteoporosis indications, 80 mcg daily regimen, two-year lifetime recommendation, pivotal outcome tables, mechanism, adverse reactions, and osteosarcoma precautions.
- Participants / model
- Postmenopausal women and men with osteoporosis at high fracture risk under the labeled criteria
- Treatment
- TYMLOS 80 mcg subcutaneously once daily
- Follow-up
- Current label revised August 2026; clinical trials ran 18 months in women and 12 months in men
- Study design
- Regulatory prescribing information
The male indication is to increase bone density. The women's indication includes vertebral and nonvertebral fracture reduction.
Read the original sourceACTIVE · JAMA 2016
Randomized controlled trial
Miller PD et al. JAMA. 2016;316(7):722-733. doi:10.1001/jama.2016.11136. PMID: 27533157.
Among 2,463 randomized women, abaloparatide reduced new vertebral and nonvertebral fractures versus placebo and increased BMD over 18 months.
- Participants / model
- Postmenopausal women with osteoporosis
- Treatment
- Abaloparatide 80 mcg daily versus placebo; open-label teriparatide was an additional arm
- Follow-up
- 18 months, with nonvertebral follow-up through 19 months
- Study design
- Phase 3 multicenter randomized double-blind placebo-controlled trial with an open-label active comparator arm
- Funding
- Radius Health
The vertebral analysis used evaluable radiographs and smaller denominators than the randomized population. The article reported funding and author relationships with the sponsor.
Read the original sourceATOM · JBMR 2022
Randomized controlled trial
Czerwinski E et al. Journal of Bone and Mineral Research. 2022;37(12):2435-2442. doi:10.1002/jbmr.4719. PMID: 36190391.
In 228 men, abaloparatide produced larger 12-month BMD gains than placebo at the lumbar spine, total hip, and femoral neck.
- Participants / model
- Men aged 42 to 85 years with osteoporosis
- Treatment
- Abaloparatide 80 mcg daily versus placebo, randomized 2:1
- Follow-up
- 12 months
- Study design
- Phase 3 randomized double-blind placebo-controlled trial; primary endpoint was lumbar-spine BMD
- Funding
- Radius Health; sponsor employees were authors
The study established BMD effects and was not a fracture-outcome trial.
Read the original sourceHow long is treatment, and what happened after it stopped?
The current label says safety and efficacy have not been evaluated beyond two years and recommends against more than two years of lifetime use. In ACTIVExtend, women who completed the abaloparatide or placebo arms of ACTIVE could enroll and all received weekly alendronate for up to 24 months.
Of the ACTIVE completers, 558 women previously assigned abaloparatide and 581 previously assigned placebo entered the extension. Over the full 43-month period, new radiographic vertebral fractures occurred in 0.9% of evaluable women in the abaloparatide-then-alendronate group and 5.6% in the placebo-then-alendronate group.
TYMLOS label · August 2026
FDA prescribing information
Radius Health. TYMLOS (abaloparatide) prescribing information. Revised August 2026.
Defines the sex-specific osteoporosis indications, 80 mcg daily regimen, two-year lifetime recommendation, pivotal outcome tables, mechanism, adverse reactions, and osteosarcoma precautions.
- Participants / model
- Postmenopausal women and men with osteoporosis at high fracture risk under the labeled criteria
- Treatment
- TYMLOS 80 mcg subcutaneously once daily
- Follow-up
- Current label revised August 2026; clinical trials ran 18 months in women and 12 months in men
- Study design
- Regulatory prescribing information
The male indication is to increase bone density. The women's indication includes vertebral and nonvertebral fracture reduction.
Read the original sourceACTIVExtend · JCEM 2018
Clinical extension study
Bone HG et al. Journal of Clinical Endocrinology and Metabolism. 2018;103(8):2949-2957. doi:10.1210/jc.2018-00163. PMID: 29800372.
Among eligible ACTIVE completers who entered the extension, 18 months of abaloparatide followed by up to 24 months of alendronate preserved BMD gains and was associated with fewer fractures than placebo followed by alendronate.
- Participants / model
- Postmenopausal women who completed the abaloparatide or placebo arms of ACTIVE and enrolled in the extension
- Treatment
- Prior randomized abaloparatide or placebo, then open-label alendronate 70 mg weekly in both groups
- Follow-up
- Up to 43 months from original ACTIVE baseline
- Study design
- Prospective open-label extension retaining original randomized-group history
- Funding
- Radius Health; sponsor employees were authors
Extension enrollment selected trial completers. It was not a fresh randomized comparison of abaloparatide with alendronate.
Read the original sourceWhat does a PTHrP analog do to adult bone?
Abaloparatide is a synthetic analog of the first 34 amino acids of parathyroid hormone-related protein. It activates the PTH1 receptor. The label describes increased bone formation on trabecular and cortical bone surfaces. That is remodeling of existing adult bone, not renewed lengthening at a growth plate.
- Target: PTH1 receptor.
- Tissue result: increased osteoblastic bone formation on existing surfaces.
- Clinical result studied: fracture reduction and BMD change in defined osteoporosis populations.
TYMLOS label · August 2026
FDA prescribing information
Radius Health. TYMLOS (abaloparatide) prescribing information. Revised August 2026.
Defines the sex-specific osteoporosis indications, 80 mcg daily regimen, two-year lifetime recommendation, pivotal outcome tables, mechanism, adverse reactions, and osteosarcoma precautions.
- Participants / model
- Postmenopausal women and men with osteoporosis at high fracture risk under the labeled criteria
- Treatment
- TYMLOS 80 mcg subcutaneously once daily
- Follow-up
- Current label revised August 2026; clinical trials ran 18 months in women and 12 months in men
- Study design
- Regulatory prescribing information
The male indication is to increase bone density. The women's indication includes vertebral and nonvertebral fracture reduction.
Read the original sourceWhat is known about osteosarcoma, and from which evidence type?
The tumor signal is real in rats and uncertain in humans. Two-year rat studies produced a dose-dependent rise in osteosarcoma at systemic exposures 4 to 28 times the human exposure at the 80 mcg dose. The current label says it is unknown whether abaloparatide causes osteosarcoma in humans. Postmarketing cases have occurred with a PTH analog, but human observational studies have not shown an increased risk, and data beyond two years remain limited.
| Evidence type | Finding | What it means |
|---|---|---|
| Rat carcinogenicity study | Dose-dependent osteosarcoma at 4 to 28 times human exposure | Animal hazard signal |
| Human observational evidence | No increased osteosarcoma risk observed | Reassuring but not proof of zero risk |
| Current label precaution | Avoid specified higher-baseline-risk groups | Clinical risk management under uncertainty |
The label says to avoid use with open epiphyses, Paget disease or another metabolic bone disease besides osteoporosis, bone metastases or prior skeletal malignancy, skeletal radiation, or a hereditary osteosarcoma predisposition.
TYMLOS label · August 2026
FDA prescribing information
Radius Health. TYMLOS (abaloparatide) prescribing information. Revised August 2026.
Defines the sex-specific osteoporosis indications, 80 mcg daily regimen, two-year lifetime recommendation, pivotal outcome tables, mechanism, adverse reactions, and osteosarcoma precautions.
- Participants / model
- Postmenopausal women and men with osteoporosis at high fracture risk under the labeled criteria
- Treatment
- TYMLOS 80 mcg subcutaneously once daily
- Follow-up
- Current label revised August 2026; clinical trials ran 18 months in women and 12 months in men
- Study design
- Regulatory prescribing information
The male indication is to increase bone density. The women's indication includes vertebral and nonvertebral fracture reduction.
Read the original sourceWhat should a patient expect and what needs action?
Orthostatic symptoms can occur within four hours of an injection, so the first doses should be given where the patient can sit or lie down. In the women's trial, dizziness was reported by 10% with abaloparatide and 6% with placebo, nausea by 8% and 3%, headache by 8% and 6%, and palpitations by 5% and 0.4%. Ten percent stopped abaloparatide because of adverse events versus 6% on placebo.
- Severe hypersensitivity is a contraindication. Anaphylaxis, angioedema, breathing difficulty, and urticaria require urgent assessment.
- Hypercalcemia can occur. Pre-existing hypercalcemia or a hypercalcemic disorder such as primary hyperparathyroidism argues against use.
- Hypercalciuria can occur. Suspected active stones or pre-existing high urine calcium may warrant urine-calcium measurement.
- The label lists no dedicated drug-interaction section findings, but that does not remove the need to review other calcium-raising treatment and the full medication plan.
TYMLOS label · August 2026
FDA prescribing information
Radius Health. TYMLOS (abaloparatide) prescribing information. Revised August 2026.
Defines the sex-specific osteoporosis indications, 80 mcg daily regimen, two-year lifetime recommendation, pivotal outcome tables, mechanism, adverse reactions, and osteosarcoma precautions.
- Participants / model
- Postmenopausal women and men with osteoporosis at high fracture risk under the labeled criteria
- Treatment
- TYMLOS 80 mcg subcutaneously once daily
- Follow-up
- Current label revised August 2026; clinical trials ran 18 months in women and 12 months in men
- Study design
- Regulatory prescribing information
The male indication is to increase bone density. The women's indication includes vertebral and nonvertebral fracture reduction.
Read the original sourceCan abaloparatide make an adult taller?
The cited clinical evidence does not establish adult-height gain. The pivotal programs studied osteoporosis fractures and bone density, and the US label contains no height indication. Its warning to avoid use with open epiphyses is an osteosarcoma-risk precaution, not a growth protocol.
TYMLOS label · August 2026
FDA prescribing information
Radius Health. TYMLOS (abaloparatide) prescribing information. Revised August 2026.
Defines the sex-specific osteoporosis indications, 80 mcg daily regimen, two-year lifetime recommendation, pivotal outcome tables, mechanism, adverse reactions, and osteosarcoma precautions.
- Participants / model
- Postmenopausal women and men with osteoporosis at high fracture risk under the labeled criteria
- Treatment
- TYMLOS 80 mcg subcutaneously once daily
- Follow-up
- Current label revised August 2026; clinical trials ran 18 months in women and 12 months in men
- Study design
- Regulatory prescribing information
The male indication is to increase bone density. The women's indication includes vertebral and nonvertebral fracture reduction.
Read the original sourceACTIVE · JAMA 2016
Randomized controlled trial
Miller PD et al. JAMA. 2016;316(7):722-733. doi:10.1001/jama.2016.11136. PMID: 27533157.
Among 2,463 randomized women, abaloparatide reduced new vertebral and nonvertebral fractures versus placebo and increased BMD over 18 months.
- Participants / model
- Postmenopausal women with osteoporosis
- Treatment
- Abaloparatide 80 mcg daily versus placebo; open-label teriparatide was an additional arm
- Follow-up
- 18 months, with nonvertebral follow-up through 19 months
- Study design
- Phase 3 multicenter randomized double-blind placebo-controlled trial with an open-label active comparator arm
- Funding
- Radius Health
The vertebral analysis used evaluable radiographs and smaller denominators than the randomized population. The article reported funding and author relationships with the sponsor.
Read the original sourceATOM · JBMR 2022
Randomized controlled trial
Czerwinski E et al. Journal of Bone and Mineral Research. 2022;37(12):2435-2442. doi:10.1002/jbmr.4719. PMID: 36190391.
In 228 men, abaloparatide produced larger 12-month BMD gains than placebo at the lumbar spine, total hip, and femoral neck.
- Participants / model
- Men aged 42 to 85 years with osteoporosis
- Treatment
- Abaloparatide 80 mcg daily versus placebo, randomized 2:1
- Follow-up
- 12 months
- Study design
- Phase 3 randomized double-blind placebo-controlled trial; primary endpoint was lumbar-spine BMD
- Funding
- Radius Health; sponsor employees were authors
The study established BMD effects and was not a fracture-outcome trial.
Read the original sourceWhich studies define the fracture, bone-density, and follow-on treatment results?
The current US label supplies product identity, indication, dosing, trial tables, and safety language. ACTIVE reports the women’s fracture trial, ATOM the men’s bone-density trial, and ACTIVExtend the alendronate follow-on period.
TYMLOS label · August 2026
FDA prescribing information
Radius Health. TYMLOS (abaloparatide) prescribing information. Revised August 2026.
Defines the sex-specific osteoporosis indications, 80 mcg daily regimen, two-year lifetime recommendation, pivotal outcome tables, mechanism, adverse reactions, and osteosarcoma precautions.
- Participants / model
- Postmenopausal women and men with osteoporosis at high fracture risk under the labeled criteria
- Treatment
- TYMLOS 80 mcg subcutaneously once daily
- Follow-up
- Current label revised August 2026; clinical trials ran 18 months in women and 12 months in men
- Study design
- Regulatory prescribing information
The male indication is to increase bone density. The women's indication includes vertebral and nonvertebral fracture reduction.
Read the original sourceACTIVE · JAMA 2016
Randomized controlled trial
Miller PD et al. JAMA. 2016;316(7):722-733. doi:10.1001/jama.2016.11136. PMID: 27533157.
Among 2,463 randomized women, abaloparatide reduced new vertebral and nonvertebral fractures versus placebo and increased BMD over 18 months.
- Participants / model
- Postmenopausal women with osteoporosis
- Treatment
- Abaloparatide 80 mcg daily versus placebo; open-label teriparatide was an additional arm
- Follow-up
- 18 months, with nonvertebral follow-up through 19 months
- Study design
- Phase 3 multicenter randomized double-blind placebo-controlled trial with an open-label active comparator arm
- Funding
- Radius Health
The vertebral analysis used evaluable radiographs and smaller denominators than the randomized population. The article reported funding and author relationships with the sponsor.
Read the original sourceATOM · JBMR 2022
Randomized controlled trial
Czerwinski E et al. Journal of Bone and Mineral Research. 2022;37(12):2435-2442. doi:10.1002/jbmr.4719. PMID: 36190391.
In 228 men, abaloparatide produced larger 12-month BMD gains than placebo at the lumbar spine, total hip, and femoral neck.
- Participants / model
- Men aged 42 to 85 years with osteoporosis
- Treatment
- Abaloparatide 80 mcg daily versus placebo, randomized 2:1
- Follow-up
- 12 months
- Study design
- Phase 3 randomized double-blind placebo-controlled trial; primary endpoint was lumbar-spine BMD
- Funding
- Radius Health; sponsor employees were authors
The study established BMD effects and was not a fracture-outcome trial.
Read the original sourceACTIVExtend · JCEM 2018
Clinical extension study
Bone HG et al. Journal of Clinical Endocrinology and Metabolism. 2018;103(8):2949-2957. doi:10.1210/jc.2018-00163. PMID: 29800372.
Among eligible ACTIVE completers who entered the extension, 18 months of abaloparatide followed by up to 24 months of alendronate preserved BMD gains and was associated with fewer fractures than placebo followed by alendronate.
- Participants / model
- Postmenopausal women who completed the abaloparatide or placebo arms of ACTIVE and enrolled in the extension
- Treatment
- Prior randomized abaloparatide or placebo, then open-label alendronate 70 mg weekly in both groups
- Follow-up
- Up to 43 months from original ACTIVE baseline
- Study design
- Prospective open-label extension retaining original randomized-group history
- Funding
- Radius Health; sponsor employees were authors
Extension enrollment selected trial completers. It was not a fresh randomized comparison of abaloparatide with alendronate.
Read the original sourceStudies and sources
TYMLOS label · August 2026
FDA prescribing information
Radius Health. TYMLOS (abaloparatide) prescribing information. Revised August 2026.
Defines the sex-specific osteoporosis indications, 80 mcg daily regimen, two-year lifetime recommendation, pivotal outcome tables, mechanism, adverse reactions, and osteosarcoma precautions.
- Participants / model
- Postmenopausal women and men with osteoporosis at high fracture risk under the labeled criteria
- Treatment
- TYMLOS 80 mcg subcutaneously once daily
- Follow-up
- Current label revised August 2026; clinical trials ran 18 months in women and 12 months in men
- Study design
- Regulatory prescribing information
The male indication is to increase bone density. The women's indication includes vertebral and nonvertebral fracture reduction.
Read the original sourceACTIVE · JAMA 2016
Randomized controlled trial
Miller PD et al. JAMA. 2016;316(7):722-733. doi:10.1001/jama.2016.11136. PMID: 27533157.
Among 2,463 randomized women, abaloparatide reduced new vertebral and nonvertebral fractures versus placebo and increased BMD over 18 months.
- Participants / model
- Postmenopausal women with osteoporosis
- Treatment
- Abaloparatide 80 mcg daily versus placebo; open-label teriparatide was an additional arm
- Follow-up
- 18 months, with nonvertebral follow-up through 19 months
- Study design
- Phase 3 multicenter randomized double-blind placebo-controlled trial with an open-label active comparator arm
- Funding
- Radius Health
The vertebral analysis used evaluable radiographs and smaller denominators than the randomized population. The article reported funding and author relationships with the sponsor.
Read the original sourceATOM · JBMR 2022
Randomized controlled trial
Czerwinski E et al. Journal of Bone and Mineral Research. 2022;37(12):2435-2442. doi:10.1002/jbmr.4719. PMID: 36190391.
In 228 men, abaloparatide produced larger 12-month BMD gains than placebo at the lumbar spine, total hip, and femoral neck.
- Participants / model
- Men aged 42 to 85 years with osteoporosis
- Treatment
- Abaloparatide 80 mcg daily versus placebo, randomized 2:1
- Follow-up
- 12 months
- Study design
- Phase 3 randomized double-blind placebo-controlled trial; primary endpoint was lumbar-spine BMD
- Funding
- Radius Health; sponsor employees were authors
The study established BMD effects and was not a fracture-outcome trial.
Read the original sourceACTIVExtend · JCEM 2018
Clinical extension study
Bone HG et al. Journal of Clinical Endocrinology and Metabolism. 2018;103(8):2949-2957. doi:10.1210/jc.2018-00163. PMID: 29800372.
Among eligible ACTIVE completers who entered the extension, 18 months of abaloparatide followed by up to 24 months of alendronate preserved BMD gains and was associated with fewer fractures than placebo followed by alendronate.
- Participants / model
- Postmenopausal women who completed the abaloparatide or placebo arms of ACTIVE and enrolled in the extension
- Treatment
- Prior randomized abaloparatide or placebo, then open-label alendronate 70 mg weekly in both groups
- Follow-up
- Up to 43 months from original ACTIVE baseline
- Study design
- Prospective open-label extension retaining original randomized-group history
- Funding
- Radius Health; sponsor employees were authors
Extension enrollment selected trial completers. It was not a fresh randomized comparison of abaloparatide with alendronate.
Read the original sourceWhy is Abaloparatide in S tier?
S reflects an approved osteoporosis medicine and randomized fracture evidence in postmenopausal women. In men, the pivotal trial found bone-density gains but did not test fracture reduction. No trial or label supports adult-height use.
read Abaloparatide in the reptides guide, chapter 10: 12 pages, free to read.