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Study · Randomized controlled trial · 2022

7 results

Abaloparatide Increases Lumbar Spine and Hip BMD in Japanese Patients With Osteoporosis: The Phase 3 ACTIVE-J Study.

Matsumoto T, Sone T, Soen S, Tanaka S, Yamashita A, Inoue T

The Journal of clinical endocrinology and metabolism1 Sept 2022Cited by 34 (Europe PMC)

PMID35977548 (opens in a new tab)PMCIDPMC9516124 (opens in a new tab)DOI10.1210/clinem/dgac486 (opens in a new tab)PepBankPUB-35977548
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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-ND. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with osteoporosis, abaloparatide increased lumbar spine BMD by 12.5% versus placebo.

    In plain wordsIn Japanese patients with osteoporosis, abaloparatide increased lower spine bone density more than placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseLumbar spine BMD
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 µg daily · subcutaneous · 78 weeksAs given in this study (human).

    Measurements

    Lumbar spine BMD increase
    12.5%
    versus placebo

    Source sentences

    Summary
    Abaloparatide increased LS, TH, and FN BMDs (mean [95% CI]) by 12.5% (10.3%-14.8%; P < .001), 4.3% (3.3%-5.3%), and 4.3% (2.9%-5.6%), respectively, vs placebo.
    2 context sentences
    Summary · context
    This was a randomized, double-blind, placebo-controlled study conducted in Japan.
    Summary · context
    Postmenopausal women and men with osteoporosis with high fracture risk were given daily subcutaneous 80 µg abaloparatide or placebo for 78 weeks (18 months).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with osteoporosis, abaloparatide increased total hip BMD by 4.3% versus placebo.

    In plain wordsIn Japanese patients with osteoporosis, abaloparatide increased total hip bone density more than placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseTotal hip BMD
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 µg daily · subcutaneous · 78 weeksAs given in this study (human).

    Measurements

    Total hip BMD increase
    4.3%
    versus placebo

    Source sentences

    Summary
    Abaloparatide increased LS, TH, and FN BMDs (mean [95% CI]) by 12.5% (10.3%-14.8%; P < .001), 4.3% (3.3%-5.3%), and 4.3% (2.9%-5.6%), respectively, vs placebo.
    2 context sentences
    Summary · context
    This was a randomized, double-blind, placebo-controlled study conducted in Japan.
    Summary · context
    Postmenopausal women and men with osteoporosis with high fracture risk were given daily subcutaneous 80 µg abaloparatide or placebo for 78 weeks (18 months).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with osteoporosis, abaloparatide increased femoral neck BMD by 4.3% versus placebo.

    In plain wordsIn Japanese patients with osteoporosis, abaloparatide increased femoral neck bone density more than placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseFemoral neck BMD
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 µg daily · subcutaneous · 78 weeksAs given in this study (human).

    Measurements

    Femoral neck BMD increase
    4.3%
    versus placebo

    Source sentences

    Summary
    Abaloparatide increased LS, TH, and FN BMDs (mean [95% CI]) by 12.5% (10.3%-14.8%; P < .001), 4.3% (3.3%-5.3%), and 4.3% (2.9%-5.6%), respectively, vs placebo.
    2 context sentences
    Summary · context
    This was a randomized, double-blind, placebo-controlled study conducted in Japan.
    Summary · context
    Postmenopausal women and men with osteoporosis with high fracture risk were given daily subcutaneous 80 µg abaloparatide or placebo for 78 weeks (18 months).
  4. 04HumanRandomized controlled trialEfficacy outcome

    In Japanese patients receiving abaloparatide, serum procollagen type I N-terminal propeptide peaked above baseline and remained elevated at study end.

    In plain wordsIn Japanese patients receiving abaloparatide, a bone formation marker rose and remained above baseline.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseSerum procollagen type I N-terminal propeptide
    Study

    n: not reported in source

    Comparator
    Baseline
    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 µg daily · subcutaneous · 78 weeksAs given in this study (human).

    Measurements

    Increase above baseline
    ≈ 140%
    6 weeks
    Increase above baseline
    ≈ 25%
    78 weeks

    Source sentences

    Summary
    Serum procollagen type I N-terminal propeptide increased rapidly to ~ 140% above baseline at 6 weeks and gradually decreased but was approximately 25% higher than baseline at 78 weeks.
    2 context sentences
    Summary · context
    This was a randomized, double-blind, placebo-controlled study conducted in Japan.
    Summary · context
    Postmenopausal women and men with osteoporosis with high fracture risk were given daily subcutaneous 80 µg abaloparatide or placebo for 78 weeks (18 months).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In Japanese patients receiving abaloparatide, serum resorption marker levels rose above baseline, then declined to placebo levels.

    In plain wordsIn Japanese patients receiving abaloparatide, a bone breakdown marker rose above baseline, then fell to placebo levels.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    MixedSerum collagen type I carboxy-terminal telopeptide
    Study

    n: not reported in source

    Comparator
    Baseline and placebo
    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 µg daily · subcutaneous · 78 weeksAs given in this study (human).

    Measurements

    Increase above baseline
    50%
    24 weeks

    Source sentences

    Summary
    Serum carboxy-terminal cross-linking telopeptide of type I collagen gradually increased to 50% above baseline at 24 weeks and decreased gradually to the placebo-group level from 60 weeks.
    2 context sentences
    Summary · context
    This was a randomized, double-blind, placebo-controlled study conducted in Japan.
    Summary · context
    Postmenopausal women and men with osteoporosis with high fracture risk were given daily subcutaneous 80 µg abaloparatide or placebo for 78 weeks (18 months).
  6. 06HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with osteoporosis, no new vertebral fractures occurred with abaloparatide, while placebo participants developed new fractures.

    In plain wordsIn Japanese patients with osteoporosis, no new spinal fractures occurred with abaloparatide, while some occurred with placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    DecreaseNew vertebral fractures
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 µg daily · subcutaneous · 78 weeksAs given in this study (human).

    Measurements

    Participants with new vertebral fractures
    3 participants
    placebo
    Vertebrae with new fractures
    4 vertebrae
    placebo

    Source sentences

    Summary
    Four vertebrae of 3 participants in the placebo group, but none in the abaloparatide group, developed new vertebral fractures.
    2 context sentences
    Summary · context
    This was a randomized, double-blind, placebo-controlled study conducted in Japan.
    Summary · context
    Postmenopausal women and men with osteoporosis with high fracture risk were given daily subcutaneous 80 µg abaloparatide or placebo for 78 weeks (18 months).
  7. 07HumanRandomized controlled trialSafety outcome

    In Japanese patients with osteoporosis, the abaloparatide safety profile was similar to that in ACTIVE.

    In plain wordsIn Japanese patients with osteoporosis, abaloparatide safety was similar to the earlier ACTIVE study.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Direction not reportedOverall safety profile
    Study

    n: not reported in source

    Comparator
    ACTIVE study safety profile
    Outcome group
    Adverse events · Whole body
    Studied dose
    80 µg daily · subcutaneous · 78 weeksAs given in this study (human).

    Source sentences

    Summary
    The safety profile was similar to that in the ACTIVE study.
    2 context sentences
    Summary · context
    This was a randomized, double-blind, placebo-controlled study conducted in Japan.
    Summary · context
    Postmenopausal women and men with osteoporosis with high fracture risk were given daily subcutaneous 80 µg abaloparatide or placebo for 78 weeks (18 months).

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.

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