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Study · Randomized controlled trial · 2019

8 results

Fracture and Bone Mineral Density Response by Baseline Risk in Patients Treated With Abaloparatide Followed by Alendronate: Results From the Phase 3 ACTIVExtend Trial.

Leder BZ, Zapalowski C, Hu MY, Hattersley G, Lane NE, Singer AJ, Dore RK

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research11 Sept 2019Cited by 14 (Europe PMC)

PMID31411768 (opens in a new tab)PMCIDPMC6916366 (opens in a new tab)DOI10.1002/jbmr.3848 (opens in a new tab)PepBankPUB-31411768
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Summary

In the randomized, placebo-controlled, double-blind phase 3 ACTIVE study (NCT01343004), 18 months of abaloparatide 80 μg daily (subcutaneous injection) in postmenopausal women at risk of osteoporotic fracture significantly reduced the risk of vertebral, nonvertebral, clinical, and major osteoporotic fractures and significantly increased bone mineral density (BMD) versus placebo regardless of baseline risk factors. Women from the abaloparatide and placebo groups who completed ACTIVE were eligible for ACTIVExtend (NCT01657162), in which all enrollees received sequential, open-label monotherapy with alendronate 70 mg once weekly for up to 24 months. This prespecified analysis evaluated whether fracture risk reductions and bone mineral density (BMD) gains associated with abaloparatide during ACTIVE persisted through the full 43-month ACTIVE-ACTIVExtend study period in nine prespecified baseline risk subgroups. Baseline risk subgroups included BMD T-score at the lumbar spine, total hip, and femoral neck (≤ - 2.5 versus > - 2.5 and ≤ -3.0 versus > - 3.0), history of nonvertebral fracture (yes/no), prevalent vertebral fracture (yes/no), and age (<65 versus 65 to <75 versus ≥75 years). Forest plots display treatment effect. Treatment-by-subgroup interactions were tested using the Breslow-Day test, Cox proportional hazards model, and ANCOVA model. After the combined ACTIVE-ACTIVExtend study period, reductions in relative risk for new vertebral, nonvertebral, clinical, and major osteoporotic fractures were greater among patients in the abaloparatide/alendronate group than among those in the placebo/alendronate group across all nine baseline risk subgroups. BMD gains at the lumbar spine, total hip, and femoral neck were greater in the abaloparatide/alendronate group versus the placebo/alendronate group. No clinically meaningful interaction between treatment assignment and any baseline risk variable was observed. The sequence of abaloparatide for 18 months followed by alendronate for up to 24 months appears to be an effective treatment option for a wide range of postmenopausal women at risk for osteoporotic fractures. © 2019 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals, Inc.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women, abaloparatide/alendronate reduced new vertebral fracture risk more than placebo/alendronate across baseline risk subgroups.

    In plain wordsIn postmenopausal women, abaloparatide then alendronate reduced vertebral fracture risk more than placebo then alendronate across risk subgroups.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    DecreaseNew vertebral fracture risk across baseline risk subgroups
    Study

    n: not reported in source

    Comparator
    Placebo followed by alendronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 μg daily · subcutaneous injection · 18 monthsAs given in this study (human).

    Source sentences

    Summary
    After the combined ACTIVE-ACTIVExtend study period, reductions in relative risk for new vertebral, nonvertebral, clinical, and major osteoporotic fractures were greater among patients in the abaloparatide/alendronate group than among those in the placebo/alendronate group across all nine baseline risk subgroups.
    2 context sentences
    Summary · context
    Women from the abaloparatide and placebo groups who completed ACTIVE were eligible for ACTIVExtend (NCT01657162), in which all enrollees received sequential, open-label monotherapy with alendronate 70 mg once weekly for up to 24 months.
    Summary · context
    This prespecified analysis evaluated whether fracture risk reductions and bone mineral density (BMD) gains associated with abaloparatide during ACTIVE persisted through the full 43-month ACTIVE-ACTIVExtend study period in nine prespecified baseline risk subgroups.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women, abaloparatide/alendronate reduced nonvertebral fracture risk more than placebo/alendronate across baseline risk subgroups.

    In plain wordsIn postmenopausal women, abaloparatide then alendronate reduced nonvertebral fracture risk more than placebo then alendronate across risk subgroups.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    DecreaseNonvertebral fracture risk across baseline risk subgroups
    Study

    n: not reported in source

    Comparator
    Placebo followed by alendronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 μg daily · subcutaneous injection · 18 monthsAs given in this study (human).

    Source sentences

    Summary
    After the combined ACTIVE-ACTIVExtend study period, reductions in relative risk for new vertebral, nonvertebral, clinical, and major osteoporotic fractures were greater among patients in the abaloparatide/alendronate group than among those in the placebo/alendronate group across all nine baseline risk subgroups.
    2 context sentences
    Summary · context
    Women from the abaloparatide and placebo groups who completed ACTIVE were eligible for ACTIVExtend (NCT01657162), in which all enrollees received sequential, open-label monotherapy with alendronate 70 mg once weekly for up to 24 months.
    Summary · context
    This prespecified analysis evaluated whether fracture risk reductions and bone mineral density (BMD) gains associated with abaloparatide during ACTIVE persisted through the full 43-month ACTIVE-ACTIVExtend study period in nine prespecified baseline risk subgroups.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women, abaloparatide/alendronate reduced clinical fracture risk more than placebo/alendronate across baseline risk subgroups.

    In plain wordsIn postmenopausal women, abaloparatide then alendronate reduced clinical fracture risk more than placebo then alendronate across risk subgroups.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    DecreaseClinical fracture risk across baseline risk subgroups
    Study

    n: not reported in source

    Comparator
    Placebo followed by alendronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 μg daily · subcutaneous injection · 18 monthsAs given in this study (human).

    Source sentences

    Summary
    After the combined ACTIVE-ACTIVExtend study period, reductions in relative risk for new vertebral, nonvertebral, clinical, and major osteoporotic fractures were greater among patients in the abaloparatide/alendronate group than among those in the placebo/alendronate group across all nine baseline risk subgroups.
    2 context sentences
    Summary · context
    Women from the abaloparatide and placebo groups who completed ACTIVE were eligible for ACTIVExtend (NCT01657162), in which all enrollees received sequential, open-label monotherapy with alendronate 70 mg once weekly for up to 24 months.
    Summary · context
    This prespecified analysis evaluated whether fracture risk reductions and bone mineral density (BMD) gains associated with abaloparatide during ACTIVE persisted through the full 43-month ACTIVE-ACTIVExtend study period in nine prespecified baseline risk subgroups.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women, abaloparatide/alendronate reduced major osteoporotic fracture risk more than placebo/alendronate across baseline risk subgroups.

    In plain wordsIn postmenopausal women, abaloparatide then alendronate reduced major osteoporotic fracture risk more than placebo then alendronate across risk subgroups.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    DecreaseMajor osteoporotic fracture risk across baseline risk subgroups
    Study

    n: not reported in source

    Comparator
    Placebo followed by alendronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 μg daily · subcutaneous injection · 18 monthsAs given in this study (human).

    Source sentences

    Summary
    After the combined ACTIVE-ACTIVExtend study period, reductions in relative risk for new vertebral, nonvertebral, clinical, and major osteoporotic fractures were greater among patients in the abaloparatide/alendronate group than among those in the placebo/alendronate group across all nine baseline risk subgroups.
    2 context sentences
    Summary · context
    Women from the abaloparatide and placebo groups who completed ACTIVE were eligible for ACTIVExtend (NCT01657162), in which all enrollees received sequential, open-label monotherapy with alendronate 70 mg once weekly for up to 24 months.
    Summary · context
    This prespecified analysis evaluated whether fracture risk reductions and bone mineral density (BMD) gains associated with abaloparatide during ACTIVE persisted through the full 43-month ACTIVE-ACTIVExtend study period in nine prespecified baseline risk subgroups.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women, lumbar spine BMD gains were greater with abaloparatide/alendronate than placebo/alendronate.

    In plain wordsIn postmenopausal women, spine bone density increased more with abaloparatide then alendronate than placebo then alendronate.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseLumbar spine BMD
    Study

    n: not reported in source

    Comparator
    Placebo followed by alendronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 μg daily · subcutaneous injection · 18 monthsAs given in this study (human).

    Source sentences

    Summary
    BMD gains at the lumbar spine, total hip, and femoral neck were greater in the abaloparatide/alendronate group versus the placebo/alendronate group.
    2 context sentences
    Summary · context
    Women from the abaloparatide and placebo groups who completed ACTIVE were eligible for ACTIVExtend (NCT01657162), in which all enrollees received sequential, open-label monotherapy with alendronate 70 mg once weekly for up to 24 months.
    Summary · context
    This prespecified analysis evaluated whether fracture risk reductions and bone mineral density (BMD) gains associated with abaloparatide during ACTIVE persisted through the full 43-month ACTIVE-ACTIVExtend study period in nine prespecified baseline risk subgroups.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women, total hip BMD gains were greater with abaloparatide/alendronate than placebo/alendronate.

    In plain wordsIn postmenopausal women, hip bone density increased more with abaloparatide then alendronate than placebo then alendronate.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseTotal hip BMD
    Study

    n: not reported in source

    Comparator
    Placebo followed by alendronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 μg daily · subcutaneous injection · 18 monthsAs given in this study (human).

    Source sentences

    Summary
    BMD gains at the lumbar spine, total hip, and femoral neck were greater in the abaloparatide/alendronate group versus the placebo/alendronate group.
    2 context sentences
    Summary · context
    Women from the abaloparatide and placebo groups who completed ACTIVE were eligible for ACTIVExtend (NCT01657162), in which all enrollees received sequential, open-label monotherapy with alendronate 70 mg once weekly for up to 24 months.
    Summary · context
    This prespecified analysis evaluated whether fracture risk reductions and bone mineral density (BMD) gains associated with abaloparatide during ACTIVE persisted through the full 43-month ACTIVE-ACTIVExtend study period in nine prespecified baseline risk subgroups.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women, femoral neck BMD gains were greater with abaloparatide/alendronate than placebo/alendronate.

    In plain wordsIn postmenopausal women, femoral neck bone density increased more with abaloparatide then alendronate than placebo then alendronate.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseFemoral neck BMD
    Study

    n: not reported in source

    Comparator
    Placebo followed by alendronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 μg daily · subcutaneous injection · 18 monthsAs given in this study (human).

    Source sentences

    Summary
    BMD gains at the lumbar spine, total hip, and femoral neck were greater in the abaloparatide/alendronate group versus the placebo/alendronate group.
    2 context sentences
    Summary · context
    Women from the abaloparatide and placebo groups who completed ACTIVE were eligible for ACTIVExtend (NCT01657162), in which all enrollees received sequential, open-label monotherapy with alendronate 70 mg once weekly for up to 24 months.
    Summary · context
    This prespecified analysis evaluated whether fracture risk reductions and bone mineral density (BMD) gains associated with abaloparatide during ACTIVE persisted through the full 43-month ACTIVE-ACTIVExtend study period in nine prespecified baseline risk subgroups.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women, no clinically meaningful interaction occurred between treatment assignment and baseline risk variables.

    In plain wordsIn postmenopausal women, baseline risk did not meaningfully change the difference between abaloparatide then alendronate and placebo then alendronate.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    No significant changeTreatment by baseline risk interaction
    Study

    n: not reported in source

    Comparator
    Placebo followed by alendronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 μg daily · subcutaneous injection · 18 monthsAs given in this study (human).

    Source sentences

    Summary
    No clinically meaningful interaction between treatment assignment and any baseline risk variable was observed.
    2 context sentences
    Summary · context
    Women from the abaloparatide and placebo groups who completed ACTIVE were eligible for ACTIVExtend (NCT01657162), in which all enrollees received sequential, open-label monotherapy with alendronate 70 mg once weekly for up to 24 months.
    Summary · context
    This prespecified analysis evaluated whether fracture risk reductions and bone mineral density (BMD) gains associated with abaloparatide during ACTIVE persisted through the full 43-month ACTIVE-ACTIVExtend study period in nine prespecified baseline risk subgroups.

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

Registered trials2

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

2 trials · 2 completed · 2 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01657162

Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis

Radius Health, Inc.n = 1,13920 Nov 2012 to 3 Oct 2016

Postmenopausal Osteoporosis

Trial pageClinicalTrials.govUpdated 11 Dec 2020
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

Trial pageClinicalTrials.govUpdated 1 Mar 2017

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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