Skip to content

Study · Randomized controlled trial · 2019

5 results

Effect of abaloparatide on vertebral, nonvertebral, major osteoporotic, and clinical fractures in a subset of postmenopausal women at increased risk of fracture by FRAX probability.

McCloskey EV, Fitzpatrick LA, Hu MY, Williams G, Kanis JA

Archives of osteoporosis5 Feb 2019Cited by 18 (Europe PMC)

PMID30719589 (opens in a new tab)PMCIDPMC6373333 (opens in a new tab)DOI10.1007/s11657-019-0564-7 (opens in a new tab)PepBankPUB-30719589
Download PDFPubMedAsk about this study
Jump to 5 results

Summary

We evaluated the efficacy of abaloparatide in women who were at increased risk for fracture, based on CHMP recommended risk thresholds, at the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE) study baseline. Among patients at high risk based on FRAX probabilities, 18 months of abaloparatide significantly decreased risk for all fracture endpoints compared with placebo.PurposeAbaloparatide, a novel anabolic agent for the treatment of postmenopausal osteoporosis, significantly reduced the risk of vertebral and nonvertebral fractures in the ACTIVE study compared with placebo. In this post hoc analysis, we evaluated abaloparatide's efficacy in a subset of women in the study at an increased risk of fracture at baseline, based on the Committee for Medicinal Products for Human Use (CHMP) recommended risk thresholds for inclusion in clinical trials.MethodsWomen with a baseline 10-year risk of major osteoporotic fracture ≥ 10% or hip fracture ≥ 5%, assessed using the FRAX® tool (including femoral neck bone mineral density), were included in the analysis. The proportion with one or more events of new morphometric vertebral fractures was calculated. Event rates for nonvertebral, major osteoporotic, and all clinical fractures were estimated using Kaplan-Meier analysis.ResultsFollowing 18 months of treatment, abaloparatide significantly reduced incident vertebral fractures compared with placebo (relative risk reduction = 91%; 0.5% versus 5.6%; p < 0.001). Abaloparatide treatment was also associated with significantly fewer nonvertebral, major osteoporotic, and clinical fractures compared with placebo: 2.7% versus 5.8%, p = 0.036; 1.3% versus 6.0%, p < 0.001; and 3.5% versus 8.2%, p = 0.006, respectively. The effect of abaloparatide on major osteoporotic fractures (78% reduction) was significantly greater than that seen with teriparatide (23% reduction, p = 0.007).ConclusionIn a subset of postmenopausal women at increased risk of fracture as judged by CHMP guidance, abaloparatide significantly decreased the risk of all fracture endpoints compared with placebo.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In high-risk postmenopausal women, abaloparatide reduced vertebral fractures versus placebo, with 0.5% versus 5.6% and a 91% relative risk reduction.

    In plain wordsIn high-risk postmenopausal women, abaloparatide reduced vertebral fractures compared with placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    DecreaseIncident vertebral fractures
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · 18 monthsAs given in this study (human).

    Measurements

    Incident vertebral fractures
    0.5%
    abaloparatide
    Incident vertebral fractures
    5.6%
    placebo (comparator)
    Relative risk reduction
    91%
    abaloparatide vs placebo

    Source sentences

    Summary
    Following 18 months of treatment, abaloparatide significantly reduced incident vertebral fractures compared with placebo (relative risk reduction = 91%; 0.5% versus 5.6%; p < 0.001).
    2 context sentences
    Summary · context
    In this post hoc analysis, we evaluated abaloparatide's efficacy in a subset of women in the study at an increased risk of fracture at baseline, based on the Committee for Medicinal Products for Human Use (CHMP) recommended risk thresholds for inclusion in clinical trials.
    Summary · context
    Women with a baseline 10-year risk of major osteoporotic fracture ≥ 10% or hip fracture ≥ 5%, assessed using the FRAX® tool (including femoral neck bone mineral density), were included in the analysis.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In high-risk postmenopausal women, nonvertebral fractures occurred in 2.7% with abaloparatide versus 5.8% with placebo.

    In plain wordsIn high-risk postmenopausal women, abaloparatide reduced nonvertebral fractures compared with placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    DecreaseNonvertebral fractures
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · 18 monthsAs given in this study (human).

    Measurements

    Nonvertebral fractures
    2.7%
    abaloparatide
    Nonvertebral fractures
    5.8%
    placebo (comparator)

    Source sentences

    Summary
    Abaloparatide treatment was also associated with significantly fewer nonvertebral, major osteoporotic, and clinical fractures compared with placebo: 2.7% versus 5.8%, p = 0.036; 1.3% versus 6.0%, p < 0.001; and 3.5% versus 8.2%, p = 0.006, respectively.
    2 context sentences
    Summary · context
    In this post hoc analysis, we evaluated abaloparatide's efficacy in a subset of women in the study at an increased risk of fracture at baseline, based on the Committee for Medicinal Products for Human Use (CHMP) recommended risk thresholds for inclusion in clinical trials.
    Summary · context
    Women with a baseline 10-year risk of major osteoporotic fracture ≥ 10% or hip fracture ≥ 5%, assessed using the FRAX® tool (including femoral neck bone mineral density), were included in the analysis.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In high-risk postmenopausal women, major osteoporotic fractures occurred in 1.3% with abaloparatide versus 6.0% with placebo.

    In plain wordsIn high-risk postmenopausal women, abaloparatide reduced major osteoporotic fractures compared with placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    DecreaseMajor osteoporotic fractures
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · 18 monthsAs given in this study (human).

    Measurements

    Major osteoporotic fractures
    1.3%
    abaloparatide
    Major osteoporotic fractures
    6%
    placebo (comparator)

    Source sentences

    Summary
    Abaloparatide treatment was also associated with significantly fewer nonvertebral, major osteoporotic, and clinical fractures compared with placebo: 2.7% versus 5.8%, p = 0.036; 1.3% versus 6.0%, p < 0.001; and 3.5% versus 8.2%, p = 0.006, respectively.
    2 context sentences
    Summary · context
    In this post hoc analysis, we evaluated abaloparatide's efficacy in a subset of women in the study at an increased risk of fracture at baseline, based on the Committee for Medicinal Products for Human Use (CHMP) recommended risk thresholds for inclusion in clinical trials.
    Summary · context
    Women with a baseline 10-year risk of major osteoporotic fracture ≥ 10% or hip fracture ≥ 5%, assessed using the FRAX® tool (including femoral neck bone mineral density), were included in the analysis.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In high-risk postmenopausal women, clinical fractures occurred in 3.5% with abaloparatide versus 8.2% with placebo.

    In plain wordsIn high-risk postmenopausal women, abaloparatide reduced clinical fractures compared with placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    DecreaseClinical fractures
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · 18 monthsAs given in this study (human).

    Measurements

    Clinical fractures
    3.5%
    abaloparatide
    Clinical fractures
    8.2%
    placebo (comparator)

    Source sentences

    Summary
    Abaloparatide treatment was also associated with significantly fewer nonvertebral, major osteoporotic, and clinical fractures compared with placebo: 2.7% versus 5.8%, p = 0.036; 1.3% versus 6.0%, p < 0.001; and 3.5% versus 8.2%, p = 0.006, respectively.
    2 context sentences
    Summary · context
    In this post hoc analysis, we evaluated abaloparatide's efficacy in a subset of women in the study at an increased risk of fracture at baseline, based on the Committee for Medicinal Products for Human Use (CHMP) recommended risk thresholds for inclusion in clinical trials.
    Summary · context
    Women with a baseline 10-year risk of major osteoporotic fracture ≥ 10% or hip fracture ≥ 5%, assessed using the FRAX® tool (including femoral neck bone mineral density), were included in the analysis.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In high-risk postmenopausal women, major osteoporotic fracture reduction was greater with abaloparatide than teriparatide, 78% versus 23%.

    In plain wordsIn high-risk postmenopausal women, abaloparatide reduced major osteoporotic fractures more than teriparatide.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    DecreaseMajor osteoporotic fracture reduction
    Study

    n: not reported in source

    Comparator
    Teriparatide
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · 18 monthsAs given in this study (human).

    Measurements

    Major osteoporotic fracture reduction
    78%
    abaloparatide
    Major osteoporotic fracture reduction
    23%
    teriparatide (comparator)

    Source sentences

    Summary
    The effect of abaloparatide on major osteoporotic fractures (78% reduction) was significantly greater than that seen with teriparatide (23% reduction, p = 0.007).
    2 context sentences
    Summary · context
    In this post hoc analysis, we evaluated abaloparatide's efficacy in a subset of women in the study at an increased risk of fracture at baseline, based on the Committee for Medicinal Products for Human Use (CHMP) recommended risk thresholds for inclusion in clinical trials.
    Summary · context
    Women with a baseline 10-year risk of major osteoporotic fracture ≥ 10% or hip fracture ≥ 5%, assessed using the FRAX® tool (including femoral neck bone mineral density), were included in the analysis.

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

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.

PepBank is a research reference. Talk to a doctor before you use any peptide.