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Study · Randomized controlled trial · n = 56 · 2020

7 results

Abaloparatide followed by alendronate in women ≥80 years with osteoporosis: post hoc analysis of ACTIVExtend.

Greenspan SL, Fitzpatrick LA, Mitlak B, Wang Y, Harvey NC, Deal C, Cosman F, McClung M

Menopause (New York, N.Y.)1 Oct 2020Cited by 10 (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 study7

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In older women with osteoporosis, adverse event proportions were similar between abaloparatide/alendronate and placebo/alendronate groups.

    In plain wordsIn older women, adverse events were similarly frequent after abaloparatide/alendronate or placebo/alendronate.

    Outcome
    No significant changeAdverse event proportions
    Study

    n = 56

    Comparator
    placebo/alendronate
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 18 months followed by 24 months alendronateAs given in this study (human).

    Source sentences

    Summary
    Sequential treatment with abaloparatide followed by alendronate was well tolerated; the proportion of participants reporting adverse events was similar between groups.
    1 context sentence
    Summary · context
    Post hoc analyses of bone mineral density and fracture incidence in women with osteoporosis at high risk of fracture ≥80 years from ACTIVExtend.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In women aged ≥80 years, lumbar spine BMD increased more with abaloparatide/alendronate than placebo/alendronate at month 43.

    In plain wordsIn women aged ≥80 years, abaloparatide followed by alendronate increased spine bone density more than placebo followed by alendronate.

    Outcome
    IncreaseLumbar spine BMD at month 43
    Study

    n = 46

    Comparator
    placebo/alendronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · 18 months followed by 24 months alendronateAs given in this study (human).

    Measurements

    BMD change
    17.2%
    abaloparatide/alendronate
    BMD change
    8.6%
    placebo/alendronate

    Source sentences

    Summary
    At month 43, mean percent change in bone mineral density from baseline was 17.2% abaloparatide/alendronate versus 8.6% placebo/alendronate (P < 0.0001) at the lumbar spine,
    1 context sentence
    Summary · context
    Post hoc analyses of bone mineral density and fracture incidence in women with osteoporosis at high risk of fracture ≥80 years from ACTIVExtend.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In women aged ≥80 years, total hip BMD increased more with abaloparatide/alendronate than placebo/alendronate at month 43.

    In plain wordsIn women aged ≥80 years, abaloparatide followed by alendronate increased hip bone density more than placebo followed by alendronate.

    Outcome
    IncreaseTotal hip BMD at month 43
    Study

    n = 46

    Comparator
    placebo/alendronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · 18 months followed by 24 months alendronateAs given in this study (human).

    Measurements

    BMD change
    5.3%
    abaloparatide/alendronate
    BMD change
    3%
    placebo/alendronate

    Source sentences

    Summary
    5.3% abaloparatide/alendronate versus 3.0% placebo/alendronate (P = 0.024) at the total hip,
    1 context sentence
    Summary · context
    Post hoc analyses of bone mineral density and fracture incidence in women with osteoporosis at high risk of fracture ≥80 years from ACTIVExtend.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In women aged ≥80 years, femoral neck BMD increased more with abaloparatide/alendronate than placebo/alendronate at month 43.

    In plain wordsIn women aged ≥80 years, abaloparatide followed by alendronate increased femoral neck bone density more than placebo followed by alendronate.

    Outcome
    IncreaseFemoral neck BMD at month 43
    Study

    n = 46

    Comparator
    placebo/alendronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · 18 months followed by 24 months alendronateAs given in this study (human).

    Measurements

    BMD change
    4.6%
    abaloparatide/alendronate
    BMD change
    3.1%
    placebo/alendronate

    Source sentences

    Summary
    and 4.6% abaloparatide/alendronate versus 3.1% placebo/alendronate (P = 0.044) at the femoral neck.
    1 context sentence
    Summary · context
    Post hoc analyses of bone mineral density and fracture incidence in women with osteoporosis at high risk of fracture ≥80 years from ACTIVExtend.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In women aged ≥80 years with osteoporosis, abaloparatide increased BMD at all sites versus placebo at the end of ACTIVE.

    In plain wordsIn women aged ≥80 years with osteoporosis, abaloparatide increased bone density at all sites more than placebo.

    Outcome
    IncreaseBMD at end of ACTIVE
    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).

    Source sentences

    Summary
    At the end of ACTIVE, bone mineral density increased at all sites for abaloparatide versus placebo.
    2 context sentences
    Summary · context
    In the ACTIVE trial, treatment with abaloparatide for 18 months reduced osteoporotic fracture risk and increased bone mineral density.
    Summary · context
    Post hoc analyses of bone mineral density and fracture incidence in women with osteoporosis at high risk of fracture ≥80 years from ACTIVExtend.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In older women with osteoporosis, fracture incidence was low and did not differ significantly between abaloparatide/alendronate and placebo/alendronate groups.

    In plain wordsIn older women, fractures were uncommon and did not differ significantly between abaloparatide/alendronate and placebo/alendronate.

    Outcome
    No significant changeFracture incidence
    Study

    n: not reported in source

    Comparator
    placebo/alendronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · 18 months followed by 24 months alendronateAs given in this study (human).

    Source sentences

    Summary
    Fracture incidence was low and did not differ significantly between groups.
    1 context sentence
    Summary · context
    Post hoc analyses of bone mineral density and fracture incidence in women with osteoporosis at high risk of fracture ≥80 years from ACTIVExtend.

Studies that did not test the peptide alone1

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. 07HumanNot a test of Abaloparatide (Tymlos) aloneRandomized controlled trialEfficacy outcome

    In older women with osteoporosis, BMD increased in parallel in both sequence groups during alendronate therapy.

    In plain wordsIn older women with osteoporosis, bone density increased in parallel during alendronate treatment after either abaloparatide or placebo.

    Outcome
    IncreaseBMD during alendronate treatment
    Study

    n: not reported in source

    Comparator
    placebo followed by alendronate
    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    Bone mineral density increased in parallel in both groups during alendronate therapy (19 to 43 months) in ACTIVExtend.
    1 context sentence
    Summary · context
    Post hoc analyses of bone mineral density and fracture incidence in women with osteoporosis at high risk of fracture ≥80 years from ACTIVExtend.

    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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