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Study · Randomized controlled trial · n = 1,349 · 2025

16 results

Effect of abaloparatide on fracture incidence and bone mineral density in postmenopausal women with osteoporosis at highest risk for fracture.

DeSapri KT, Clarke BL, Kostenuik P, Wang Y, Mitlak BH

Menopause (New York, N.Y.)1 May 2025Cited by 4 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study16

16 results from studies that gave the peptide. 16 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In high-risk women, reported nonvertebral fracture incidence was identical with abaloparatide and teriparatide.

    In plain wordsIn high-risk women, the reported fracture incidence outside the spine was identical with abaloparatide and teriparatide.

    Outcome
    No significant changeNonvertebral fracture incidence versus teriparatide
    Study

    n = 1,349

    Comparator
    Teriparatide
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Measurements

    Cumulative fracture incidence
    3%
    Abaloparatide and teriparatide each

    Source sentences

    Summary
    Estimated Kaplan-Meier cumulative incidence of nonvertebral fracture was 3.0%, 5.3%, and 3.0% in the abaloparatide, placebo, and teriparatide groups, respectively; 4.0%, 9.0%, 4.3% for clinical fracture; 1.6%, 6.8%, 3.0% for major osteoporotic fractures; and 1.1%, 2.1%, 2.1% for wrist fracture.
    2 context sentences
    Summary · context
    This post hoc analysis evaluated the efficacy of abaloparatide treatment in a subgroup of postmenopausal women from the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE; NCT01343004) study who met high fracture risk criteria (defined in several professional society guidelines).
    Summary · context
    A total of 2,026 participants met ≥1 fracture risk criteria defined in clinical guidelines (abaloparatide, n = 664; placebo, n = 677; teriparatide, n = 685).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In high-risk women, clinical fracture incidence was numerically lower with abaloparatide than teriparatide.

    In plain wordsIn high-risk women, clinical fractures were numerically less common with abaloparatide than teriparatide.

    Outcome
    DecreaseClinical fracture incidence versus teriparatide
    Study

    n = 1,349

    Comparator
    Teriparatide
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Measurements

    Cumulative clinical fracture incidence
    4%
    Abaloparatide
    Cumulative clinical fracture incidence
    4.3%
    Teriparatide

    Source sentences

    Summary
    Estimated Kaplan-Meier cumulative incidence of nonvertebral fracture was 3.0%, 5.3%, and 3.0% in the abaloparatide, placebo, and teriparatide groups, respectively; 4.0%, 9.0%, 4.3% for clinical fracture; 1.6%, 6.8%, 3.0% for major osteoporotic fractures; and 1.1%, 2.1%, 2.1% for wrist fracture.
    2 context sentences
    Summary · context
    This post hoc analysis evaluated the efficacy of abaloparatide treatment in a subgroup of postmenopausal women from the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE; NCT01343004) study who met high fracture risk criteria (defined in several professional society guidelines).
    Summary · context
    A total of 2,026 participants met ≥1 fracture risk criteria defined in clinical guidelines (abaloparatide, n = 664; placebo, n = 677; teriparatide, n = 685).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In high-risk women, major osteoporotic fracture incidence was numerically lower with abaloparatide than teriparatide.

    In plain wordsIn high-risk women, major osteoporosis-related fractures were numerically less common with abaloparatide than teriparatide.

    Outcome
    DecreaseMajor osteoporotic fracture incidence versus teriparatide
    Study

    n = 1,349

    Comparator
    Teriparatide
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Measurements

    Cumulative major osteoporotic fracture incidence
    1.6%
    Abaloparatide
    Cumulative major osteoporotic fracture incidence
    3%
    Teriparatide

    Source sentences

    Summary
    Estimated Kaplan-Meier cumulative incidence of nonvertebral fracture was 3.0%, 5.3%, and 3.0% in the abaloparatide, placebo, and teriparatide groups, respectively; 4.0%, 9.0%, 4.3% for clinical fracture; 1.6%, 6.8%, 3.0% for major osteoporotic fractures; and 1.1%, 2.1%, 2.1% for wrist fracture.
    2 context sentences
    Summary · context
    This post hoc analysis evaluated the efficacy of abaloparatide treatment in a subgroup of postmenopausal women from the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE; NCT01343004) study who met high fracture risk criteria (defined in several professional society guidelines).
    Summary · context
    A total of 2,026 participants met ≥1 fracture risk criteria defined in clinical guidelines (abaloparatide, n = 664; placebo, n = 677; teriparatide, n = 685).
  4. 04HumanRandomized controlled trialEfficacy outcome

    In high-risk women, wrist fracture incidence was numerically lower with abaloparatide than teriparatide.

    In plain wordsIn high-risk women, wrist fractures were numerically less common with abaloparatide than teriparatide.

    Outcome
    DecreaseWrist fracture incidence versus teriparatide
    Study

    n = 1,349

    Comparator
    Teriparatide
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Measurements

    Cumulative wrist fracture incidence
    1.1%
    Abaloparatide
    Cumulative wrist fracture incidence
    2.1%
    Teriparatide

    Source sentences

    Summary
    Estimated Kaplan-Meier cumulative incidence of nonvertebral fracture was 3.0%, 5.3%, and 3.0% in the abaloparatide, placebo, and teriparatide groups, respectively; 4.0%, 9.0%, 4.3% for clinical fracture; 1.6%, 6.8%, 3.0% for major osteoporotic fractures; and 1.1%, 2.1%, 2.1% for wrist fracture.
    2 context sentences
    Summary · context
    This post hoc analysis evaluated the efficacy of abaloparatide treatment in a subgroup of postmenopausal women from the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE; NCT01343004) study who met high fracture risk criteria (defined in several professional society guidelines).
    Summary · context
    A total of 2,026 participants met ≥1 fracture risk criteria defined in clinical guidelines (abaloparatide, n = 664; placebo, n = 677; teriparatide, n = 685).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In women at highest fracture risk, new vertebral fracture incidence was numerically lower with abaloparatide (0.72%) than teriparatide (0.99%).

    In plain wordsIn high-risk women, new spine fractures were numerically less common with abaloparatide than teriparatide.

    Outcome
    DecreaseNew vertebral fracture incidence versus teriparatide
    Study

    n = 1,349

    Comparator
    Teriparatide
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Measurements

    Cumulative new vertebral fracture incidence
    0.72%
    Abaloparatide
    Cumulative new vertebral fracture incidence
    0.99%
    Teriparatide

    Source sentences

    Summary
    New vertebral fracture risk was reduced in participants receiving abaloparatide (4 [0.72%]) and teriparatide (6 [0.99%]) versus placebo (28 [4.77%]; both P  < 0.0001).
    2 context sentences
    Summary · context
    This post hoc analysis evaluated the efficacy of abaloparatide treatment in a subgroup of postmenopausal women from the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE; NCT01343004) study who met high fracture risk criteria (defined in several professional society guidelines).
    Summary · context
    A total of 2,026 participants met ≥1 fracture risk criteria defined in clinical guidelines (abaloparatide, n = 664; placebo, n = 677; teriparatide, n = 685).
  6. 06HumanRandomized controlled trialEfficacy outcome

    In high-risk women, nonvertebral fracture incidence was numerically lower with abaloparatide than placebo.

    In plain wordsIn high-risk women, fractures outside the spine were numerically less common with abaloparatide than placebo.

    Outcome
    DecreaseNonvertebral fracture incidence versus placebo
    Study

    n = 1,341

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Measurements

    Cumulative fracture incidence
    3%
    Abaloparatide
    Cumulative fracture incidence
    5.3%
    Placebo

    Source sentences

    Summary
    Estimated Kaplan-Meier cumulative incidence of nonvertebral fracture was 3.0%, 5.3%, and 3.0% in the abaloparatide, placebo, and teriparatide groups, respectively; 4.0%, 9.0%, 4.3% for clinical fracture; 1.6%, 6.8%, 3.0% for major osteoporotic fractures; and 1.1%, 2.1%, 2.1% for wrist fracture.
    2 context sentences
    Summary · context
    This post hoc analysis evaluated the efficacy of abaloparatide treatment in a subgroup of postmenopausal women from the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE; NCT01343004) study who met high fracture risk criteria (defined in several professional society guidelines).
    Summary · context
    A total of 2,026 participants met ≥1 fracture risk criteria defined in clinical guidelines (abaloparatide, n = 664; placebo, n = 677; teriparatide, n = 685).
  7. 07HumanRandomized controlled trialEfficacy outcome

    In high-risk women, clinical fracture incidence was numerically lower with abaloparatide than placebo.

    In plain wordsIn high-risk women, clinical fractures were numerically less common with abaloparatide than placebo.

    Outcome
    DecreaseClinical fracture incidence versus placebo
    Study

    n = 1,341

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Measurements

    Cumulative clinical fracture incidence
    4%
    Abaloparatide
    Cumulative clinical fracture incidence
    9%
    Placebo

    Source sentences

    Summary
    Estimated Kaplan-Meier cumulative incidence of nonvertebral fracture was 3.0%, 5.3%, and 3.0% in the abaloparatide, placebo, and teriparatide groups, respectively; 4.0%, 9.0%, 4.3% for clinical fracture; 1.6%, 6.8%, 3.0% for major osteoporotic fractures; and 1.1%, 2.1%, 2.1% for wrist fracture.
    2 context sentences
    Summary · context
    This post hoc analysis evaluated the efficacy of abaloparatide treatment in a subgroup of postmenopausal women from the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE; NCT01343004) study who met high fracture risk criteria (defined in several professional society guidelines).
    Summary · context
    A total of 2,026 participants met ≥1 fracture risk criteria defined in clinical guidelines (abaloparatide, n = 664; placebo, n = 677; teriparatide, n = 685).
  8. 08HumanRandomized controlled trialEfficacy outcome

    In high-risk women, major osteoporotic fracture incidence was numerically lower with abaloparatide than placebo.

    In plain wordsIn high-risk women, major osteoporosis-related fractures were numerically less common with abaloparatide than placebo.

    Outcome
    DecreaseMajor osteoporotic fracture incidence versus placebo
    Study

    n = 1,341

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Measurements

    Cumulative major osteoporotic fracture incidence
    1.6%
    Abaloparatide
    Cumulative major osteoporotic fracture incidence
    6.8%
    Placebo

    Source sentences

    Summary
    Estimated Kaplan-Meier cumulative incidence of nonvertebral fracture was 3.0%, 5.3%, and 3.0% in the abaloparatide, placebo, and teriparatide groups, respectively; 4.0%, 9.0%, 4.3% for clinical fracture; 1.6%, 6.8%, 3.0% for major osteoporotic fractures; and 1.1%, 2.1%, 2.1% for wrist fracture.
    2 context sentences
    Summary · context
    This post hoc analysis evaluated the efficacy of abaloparatide treatment in a subgroup of postmenopausal women from the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE; NCT01343004) study who met high fracture risk criteria (defined in several professional society guidelines).
    Summary · context
    A total of 2,026 participants met ≥1 fracture risk criteria defined in clinical guidelines (abaloparatide, n = 664; placebo, n = 677; teriparatide, n = 685).
  9. 09HumanRandomized controlled trialEfficacy outcome

    In high-risk women, wrist fracture incidence was numerically lower with abaloparatide than placebo.

    In plain wordsIn high-risk women, wrist fractures were numerically less common with abaloparatide than placebo.

    Outcome
    DecreaseWrist fracture incidence versus placebo
    Study

    n = 1,341

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Measurements

    Cumulative wrist fracture incidence
    1.1%
    Abaloparatide
    Cumulative wrist fracture incidence
    2.1%
    Placebo

    Source sentences

    Summary
    Estimated Kaplan-Meier cumulative incidence of nonvertebral fracture was 3.0%, 5.3%, and 3.0% in the abaloparatide, placebo, and teriparatide groups, respectively; 4.0%, 9.0%, 4.3% for clinical fracture; 1.6%, 6.8%, 3.0% for major osteoporotic fractures; and 1.1%, 2.1%, 2.1% for wrist fracture.
    2 context sentences
    Summary · context
    This post hoc analysis evaluated the efficacy of abaloparatide treatment in a subgroup of postmenopausal women from the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE; NCT01343004) study who met high fracture risk criteria (defined in several professional society guidelines).
    Summary · context
    A total of 2,026 participants met ≥1 fracture risk criteria defined in clinical guidelines (abaloparatide, n = 664; placebo, n = 677; teriparatide, n = 685).
  10. 10HumanRandomized controlled trialEfficacy outcome

    In high-risk women, abaloparatide was associated with lumbar spine BMD gains at 6, 12, and 18 months.

    In plain wordsIn high-risk women, spine bone density increased from baseline with abaloparatide at 6, 12, and 18 months.

    Outcome
    IncreaseLumbar spine BMD gains
    Study

    n = 664

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Abaloparatide was associated with bone mineral density gains from baseline at the lumbar spine, total hip, and femoral neck at all time points (6, 12, and 18 mo; P  < 0.0001 for all).
    2 context sentences
    Summary · context
    This post hoc analysis evaluated the efficacy of abaloparatide treatment in a subgroup of postmenopausal women from the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE; NCT01343004) study who met high fracture risk criteria (defined in several professional society guidelines).
    Summary · context
    A total of 2,026 participants met ≥1 fracture risk criteria defined in clinical guidelines (abaloparatide, n = 664; placebo, n = 677; teriparatide, n = 685).
  11. 11HumanRandomized controlled trialEfficacy outcome

    In high-risk women, abaloparatide was associated with total hip BMD gains at 6, 12, and 18 months.

    In plain wordsIn high-risk women, total hip bone density increased from baseline with abaloparatide at 6, 12, and 18 months.

    Outcome
    IncreaseTotal hip BMD gains
    Study

    n = 664

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Abaloparatide was associated with bone mineral density gains from baseline at the lumbar spine, total hip, and femoral neck at all time points (6, 12, and 18 mo; P  < 0.0001 for all).
    2 context sentences
    Summary · context
    This post hoc analysis evaluated the efficacy of abaloparatide treatment in a subgroup of postmenopausal women from the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE; NCT01343004) study who met high fracture risk criteria (defined in several professional society guidelines).
    Summary · context
    A total of 2,026 participants met ≥1 fracture risk criteria defined in clinical guidelines (abaloparatide, n = 664; placebo, n = 677; teriparatide, n = 685).
  12. 12HumanRandomized controlled trialEfficacy outcome

    In high-risk women, abaloparatide was associated with femoral neck BMD gains at 6, 12, and 18 months.

    In plain wordsIn high-risk women, femoral neck bone density increased from baseline with abaloparatide at 6, 12, and 18 months.

    Outcome
    IncreaseFemoral neck BMD gains
    Study

    n = 664

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Abaloparatide was associated with bone mineral density gains from baseline at the lumbar spine, total hip, and femoral neck at all time points (6, 12, and 18 mo; P  < 0.0001 for all).
    2 context sentences
    Summary · context
    This post hoc analysis evaluated the efficacy of abaloparatide treatment in a subgroup of postmenopausal women from the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE; NCT01343004) study who met high fracture risk criteria (defined in several professional society guidelines).
    Summary · context
    A total of 2,026 participants met ≥1 fracture risk criteria defined in clinical guidelines (abaloparatide, n = 664; placebo, n = 677; teriparatide, n = 685).
  13. 13HumanRandomized controlled trialSafety outcome

    In high-risk women receiving abaloparatide, hypercalciuria was reported in 11.5%.

    In plain wordsAmong high-risk women receiving abaloparatide, 11.5% had excess calcium in urine.

    Outcome
    Not applicableHypercalciuria
    Study

    n = 664

    Outcome group
    Adverse events · Kidney and urinary
    Studied dose
    Dose not stated

    Measurements

    Hypercalciuria incidence
    11.5%
    Abaloparatide

    Source sentences

    Summary
    Common adverse events reported in participants treated with abaloparatide were hypercalciuria (11.5%), dizziness (11.0%), and arthralgia (8.9%).
    2 context sentences
    Summary · context
    This post hoc analysis evaluated the efficacy of abaloparatide treatment in a subgroup of postmenopausal women from the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE; NCT01343004) study who met high fracture risk criteria (defined in several professional society guidelines).
    Summary · context
    A total of 2,026 participants met ≥1 fracture risk criteria defined in clinical guidelines (abaloparatide, n = 664; placebo, n = 677; teriparatide, n = 685).
  14. 14HumanRandomized controlled trialSafety outcome

    In high-risk women receiving abaloparatide, dizziness was reported in 11.0%.

    In plain wordsAmong high-risk women receiving abaloparatide, 11.0% reported dizziness.

    Outcome
    Not applicableDizziness
    Study

    n = 664

    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    Dose not stated

    Measurements

    Dizziness incidence
    11%
    Abaloparatide

    Source sentences

    Summary
    Common adverse events reported in participants treated with abaloparatide were hypercalciuria (11.5%), dizziness (11.0%), and arthralgia (8.9%).
    2 context sentences
    Summary · context
    This post hoc analysis evaluated the efficacy of abaloparatide treatment in a subgroup of postmenopausal women from the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE; NCT01343004) study who met high fracture risk criteria (defined in several professional society guidelines).
    Summary · context
    A total of 2,026 participants met ≥1 fracture risk criteria defined in clinical guidelines (abaloparatide, n = 664; placebo, n = 677; teriparatide, n = 685).
  15. 15HumanRandomized controlled trialSafety outcome

    In high-risk women receiving abaloparatide, arthralgia was reported in 8.9%.

    In plain wordsAmong high-risk women receiving abaloparatide, 8.9% reported joint pain.

    Outcome
    Not applicableArthralgia
    Study

    n = 664

    Outcome group
    Adverse events · Musculoskeletal
    Studied dose
    Dose not stated

    Measurements

    Arthralgia incidence
    8.9%
    Abaloparatide

    Source sentences

    Summary
    Common adverse events reported in participants treated with abaloparatide were hypercalciuria (11.5%), dizziness (11.0%), and arthralgia (8.9%).
    2 context sentences
    Summary · context
    This post hoc analysis evaluated the efficacy of abaloparatide treatment in a subgroup of postmenopausal women from the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE; NCT01343004) study who met high fracture risk criteria (defined in several professional society guidelines).
    Summary · context
    A total of 2,026 participants met ≥1 fracture risk criteria defined in clinical guidelines (abaloparatide, n = 664; placebo, n = 677; teriparatide, n = 685).
  16. 16HumanRandomized controlled trialEfficacy outcome

    In women at highest fracture risk, abaloparatide reduced new vertebral fracture risk versus placebo.

    In plain wordsIn women at highest fracture risk, abaloparatide reduced new spine fractures compared with placebo.

    Outcome
    DecreaseNew vertebral fractures
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Measurements

    New vertebral fractures
    4 events
    Abaloparatide
    New vertebral fracture incidence
    0.72%
    Abaloparatide
    New vertebral fractures
    28 events
    Placebo
    New vertebral fracture incidence
    4.77%
    Placebo

    Source sentences

    Summary
    New vertebral fracture risk was reduced in participants receiving abaloparatide (4 [0.72%]) and teriparatide (6 [0.99%]) versus placebo (28 [4.77%]; both P  < 0.0001).
    2 context sentences
    Summary · context
    This post hoc analysis evaluated the efficacy of abaloparatide treatment in a subgroup of postmenopausal women from the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE; NCT01343004) study who met high fracture risk criteria (defined in several professional society guidelines).
    Summary · context
    A total of 2,026 participants met ≥1 fracture risk criteria defined in clinical guidelines (abaloparatide, n = 664; placebo, n = 677; teriparatide, n = 685).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01343004

Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women

Radius Health, Inc.n = 2,463Apr 2011 to Oct 2014

Osteoporosis · Postmenopausal Osteoporosis

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    22 Oct 2026, 02:25 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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