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Study · Randomized controlled trial · n = 1,139 · 2021

4 results

Forearm bone mineral density and fracture incidence in postmenopausal women with osteoporosis: results from the ACTIVExtend phase 3 trial.

Watts NB, Dore RK, Baim S, Mitlak B, Hattersley G, Wang Y, Rozental TD, LeBoff MS

Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA15 Sept 2020Cited by 7 (Europe PMC)

PMID32935170 (opens in a new tab)PMCIDPMC7755646 (opens in a new tab)DOI10.1007/s00198-020-05555-1 (opens in a new tab)PepBankPUB-32935170
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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. Results still quote short attributed sentences.

Results from this study4

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women, wrist fracture risk did not significantly differ between abaloparatide/alendronate and placebo/alendronate sequences.

    In plain wordsIn postmenopausal women, wrist fracture risk did not differ significantly between abaloparatide then alendronate and placebo then alendronate.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    No significant changeWrist fractures over 43 months
    Study

    n = 1,139

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

    Measurements

    Wrist fracture count
    15 women
    ABL/ALN
    Wrist fracture count
    20 women
    PBO/ALN
    Wrist fracture KM estimate
    2.8%
    ABL/ALN
    Wrist fracture KM estimate
    3.6%
    PBO/ALN
    Hazard ratio
    0.77 ratio
    ABL/ALN versus PBO/ALN
    Hazard ratio 95% CI
    0.39 to 1.5 ratio
    ABL/ALN versus PBO/ALN

    Source sentences

    Summary
    Wrist fractures over 43 months occurred in 15 women with ABL/ALN (KM estimate, 2.8%) and 20 with PBO/ALN (KM estimate, 3.6%) (HR = 0.77, 95% CI 0.39, 1.50; P = not significant).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women, abaloparatide followed by alendronate increased ultradistal radius BMD more than placebo followed by alendronate at month 25.

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

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseUltradistal radius BMD at month 25
    Study

    n = 446

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

    Measurements

    BMD change
    1.1%
    ABL/ALN at month 25
    BMD change
    −0.8%
    PBO/ALN at month 25

    Source sentences

    Summary
    At cumulative month 25, mean increase from ACTIVE baseline in ultradistal radius BMD was 1.1% (standard error, 0.49%) with ABL/ALN vs - 0.8% (0.43%) with PBO/ALN (P < 0.01).
    2 context sentences
    Summary · context
    Our objective was to determine the efficacy of ABL followed by ALN vs placebo (PBO) followed by ALN on forearm BMD and fracture risk over 43 months in ACTIVExtend.
    Summary · context
    Ultradistal and 1/3 radius BMD (ACTIVE baseline to month 43) were measured (ABL/ALN, n = 213; PBO/ALN, n = 233).

Studies that did not test the peptide alone2

In this study, Abaloparatide (Tymlos) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Abaloparatide (Tymlos).

  1. 03HumanNot a test of Abaloparatide (Tymlos) aloneRandomized controlled trialEfficacy outcome

    In postmenopausal women, one-third radius BMD decreases similar with abaloparatide and placebo persisted during subsequent alendronate treatment.

    In plain wordsIn postmenopausal women, similar forearm bone density losses with abaloparatide and placebo persisted during later alendronate treatment.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    No significant changeOne-third radius BMD
    Study

    n = 446

    Comparator
    End of ACTIVE
    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    BMD decreases at the 1/3 radius in ACTIVE (similar with ABL and PBO) were maintained through 24 months of ALN treatment in ACTIVExtend.
    2 context sentences
    Summary · context
    Our objective was to determine the efficacy of ABL followed by ALN vs placebo (PBO) followed by ALN on forearm BMD and fracture risk over 43 months in ACTIVExtend.
    Summary · context
    Ultradistal and 1/3 radius BMD (ACTIVE baseline to month 43) were measured (ABL/ALN, n = 213; PBO/ALN, n = 233).

    In this study, Abaloparatide (Tymlos) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Abaloparatide (Tymlos).

  2. 04HumanNot a test of Abaloparatide (Tymlos) aloneRandomized controlled trialEfficacy outcome

    In postmenopausal women, ultradistal radius BMD gains after abaloparatide persisted during alendronate through month 43.

    In plain wordsIn postmenopausal women, wrist bone density gains after abaloparatide persisted during later alendronate treatment.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    No significant changeUltradistal radius BMD maintenance
    Study

    n = 213

    Comparator
    BMD after abaloparatide
    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    BMD increases with ABL were maintained with ALN through month 43 in ACTIVExtend.
    2 context sentences
    Summary · context
    Our objective was to determine the efficacy of ABL followed by ALN vs placebo (PBO) followed by ALN on forearm BMD and fracture risk over 43 months in ACTIVExtend.
    Summary · context
    Ultradistal and 1/3 radius BMD (ACTIVE baseline to month 43) were measured (ABL/ALN, n = 213; PBO/ALN, n = 233).

    In this study, Abaloparatide (Tymlos) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Abaloparatide (Tymlos).

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 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

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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