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Study · Randomized controlled trial · 2025

6 results

Bone turnover markers predict changes in bone mineral density in men treated with abaloparatide: results from the abaloparatide for the treatment of men with osteoporosis (ATOM) study.

Eastell R, Brown JP, Adler RA, Lewiecki EM, Binkley N, Orwoll ES, Kendler D, Mitlak BH, Wang Y

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research1 Mar 2025Cited by 9 (Europe PMC)

PMID39791502 (opens in a new tab)PMCIDPMC11909733 (opens in a new tab)DOI10.1093/jbmr/zjaf003 (opens in a new tab)PepBankPUB-39791502
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Summary

Early increases in bone turnover markers (BTMs) in response to anabolic therapy correlate with 18-mo BMD increases in postmenopausal women with osteoporosis; however, this relationship has not been assessed in men. In this analysis, the correlation between changes from baseline in fasting intact serum procollagen type I N propeptide (PINP) and serum CTX at 1, 3, 6, and 12 mo and percent increase from baseline in BMD at 12 mo in men from the randomized phase 3 ATOM study (NCT03512262) were evaluated using Pearson's correlation coefficients. The uncoupling index (UI), a measure of the balance between markers of bone formation (PINP) and bone resorption (CTX), with positive UI favoring bone formation, was calculated. Results in men were compared to 12-mo results for women from the ACTIVE study using the z score test after Fisher's Z transformation. In abaloparatide-treated men, PINP increases at 1 mo (r = 0.485), 3 mo (r = 0.614), 6 mo (r = 0.632), and 12 mo (r = 0.521) were highly correlated (p < .0001) with 12-mo LS BMD increases. The mean UI for abaloparatide-treated men was greater than placebo as early as 1 mo (2.26 vs -0.25). At month 3, the mean UI for men was greater (1.32) than for women (0.88) (p < .001). There was a significant correlation between 3-mo UI and LS BMD at 12 mo in both men (r = 0.453; p < .001) and women (r = 0.252; p < .01). UI at months 6 and 12 were also significantly correlated with 12-mo LS BMD in men and women, but the correlation was stronger in men than women. These data support that early changes in BTMs in men treated with abaloparatide are associated with subsequent changes in BMD similar to what has been reported in women.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

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

  1. 01HumanRandomized controlled trialMechanism

    In men with osteoporosis, abaloparatide increased the mean uncoupling index compared with placebo at 1 month.

    In plain wordsIn men, abaloparatide increased the balance toward bone formation compared with placebo at 1 month.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseUncoupling index at month 1
    Study

    n: not reported in source

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

    Measurements

    Mean uncoupling index
    2.26 index
    Abaloparatide-treated men
    Mean uncoupling index
    −0.25 index
    Placebo

    Source sentences

    Summary
    The mean UI for abaloparatide-treated men was greater than placebo as early as 1 mo (2.26 vs -0.25).
    3 context sentences
    Summary · context
    The uncoupling index (UI), a measure of the balance between markers of bone formation (PINP) and bone resorption (CTX), with positive UI favoring bone formation, was calculated.
    Summary · context
    In this analysis, the correlation between changes from baseline in fasting intact serum procollagen type I N propeptide (PINP) and serum CTX at 1, 3, 6, and 12 mo and percent increase from baseline in BMD at 12 mo in men from the randomized phase 3 ATOM study (NCT03512262) were evaluated using Pearson's correlation coefficients.
    Summary · context
    Results in men were compared to 12-mo results for women from the ACTIVE study using the z score test after Fisher's Z transformation.
  2. 02HumanObservational studyMechanism

    In abaloparatide-treated men, PINP increases at each reported time correlated positively with lumbar spine BMD increases at 12 months.

    In plain wordsIn men receiving abaloparatide, increases in a bone formation marker were linked to later increases in spine bone density.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreasePINP change correlation with lumbar spine BMD
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Measurements

    Correlation
    0.485 r
    PINP at 1 mo versus 12-mo LS BMD
    Correlation
    0.614 r
    PINP at 3 mo versus 12-mo LS BMD
    Correlation
    0.632 r
    PINP at 6 mo versus 12-mo LS BMD
    Correlation
    0.521 r
    PINP at 12 mo versus 12-mo LS BMD

    Source sentences

    Summary
    In abaloparatide-treated men, PINP increases at 1 mo (r = 0.485), 3 mo (r = 0.614), 6 mo (r = 0.632), and 12 mo (r = 0.521) were highly correlated (p < .0001) with 12-mo LS BMD increases.
    2 context sentences
    Summary · context
    In this analysis, the correlation between changes from baseline in fasting intact serum procollagen type I N propeptide (PINP) and serum CTX at 1, 3, 6, and 12 mo and percent increase from baseline in BMD at 12 mo in men from the randomized phase 3 ATOM study (NCT03512262) were evaluated using Pearson's correlation coefficients.
    Summary · context
    Results in men were compared to 12-mo results for women from the ACTIVE study using the z score test after Fisher's Z transformation.
  3. 03HumanObservational studyMechanism

    In men from the ATOM study, the mean uncoupling index at month 3 was higher than in women from the ACTIVE study.

    In plain wordsAt month 3, men on abaloparatide had a higher bone formation balance index than women in the ACTIVE study.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseUncoupling index at month 3 by sex
    Study

    n: not reported in source

    Comparator
    Women from the ACTIVE study
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Measurements

    Mean uncoupling index
    1.32 index
    Men (ATOM)
    Mean uncoupling index
    0.88 index
    Women (ACTIVE)

    Source sentences

    Summary
    At month 3, the mean UI for men was greater (1.32) than for women (0.88) (p < .001).
    3 context sentences
    Summary · context
    The uncoupling index (UI), a measure of the balance between markers of bone formation (PINP) and bone resorption (CTX), with positive UI favoring bone formation, was calculated.
    Summary · context
    In this analysis, the correlation between changes from baseline in fasting intact serum procollagen type I N propeptide (PINP) and serum CTX at 1, 3, 6, and 12 mo and percent increase from baseline in BMD at 12 mo in men from the randomized phase 3 ATOM study (NCT03512262) were evaluated using Pearson's correlation coefficients.
    Summary · context
    Results in men were compared to 12-mo results for women from the ACTIVE study using the z score test after Fisher's Z transformation.
  4. 04HumanObservational studyMechanism

    In abaloparatide-treated men, month 3 uncoupling index correlated positively with lumbar spine BMD at 12 months.

    In plain wordsIn men receiving abaloparatide, the month 3 bone formation balance index was linked to later spine bone density.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseMonth 3 uncoupling index correlation with BMD in men
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Measurements

    Correlation
    0.453 r
    Men: 3-mo UI versus 12-mo LS BMD

    Source sentences

    Summary
    There was a significant correlation between 3-mo UI and LS BMD at 12 mo in both men (r = 0.453; p < .001) and women (r = 0.252; p < .01).
    2 context sentences
    Summary · context
    In this analysis, the correlation between changes from baseline in fasting intact serum procollagen type I N propeptide (PINP) and serum CTX at 1, 3, 6, and 12 mo and percent increase from baseline in BMD at 12 mo in men from the randomized phase 3 ATOM study (NCT03512262) were evaluated using Pearson's correlation coefficients.
    Summary · context
    Results in men were compared to 12-mo results for women from the ACTIVE study using the z score test after Fisher's Z transformation.
  5. 05HumanObservational studyMechanism

    In women from the ACTIVE study, month 3 uncoupling index correlated positively with lumbar spine BMD at 12 months.

    In plain wordsIn women in the ACTIVE study, the month 3 bone formation balance index was linked to later spine bone density.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseMonth 3 uncoupling index correlation with BMD in women
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Measurements

    Correlation
    0.252 r
    Women: 3-mo UI versus 12-mo LS BMD

    Source sentences

    Summary
    There was a significant correlation between 3-mo UI and LS BMD at 12 mo in both men (r = 0.453; p < .001) and women (r = 0.252; p < .01).
    2 context sentences
    Summary · context
    In this analysis, the correlation between changes from baseline in fasting intact serum procollagen type I N propeptide (PINP) and serum CTX at 1, 3, 6, and 12 mo and percent increase from baseline in BMD at 12 mo in men from the randomized phase 3 ATOM study (NCT03512262) were evaluated using Pearson's correlation coefficients.
    Summary · context
    Results in men were compared to 12-mo results for women from the ACTIVE study using the z score test after Fisher's Z transformation.
  6. 06HumanObservational studyMechanism

    In men from the ATOM study and women from the ACTIVE study, uncoupling indices at months 6 and 12 correlated with 12-month spine BMD, more strongly in men than women.

    In plain wordsUncoupling indices at months 6 and 12 correlated with 12-month spine bone density in men and women, more strongly in men.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseLater uncoupling index correlation with BMD by sex
    Study

    n: not reported in source

    Comparator
    Women from the ACTIVE study
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    UI at months 6 and 12 were also significantly correlated with 12-mo LS BMD in men and women, but the correlation was stronger in men than women.
    2 context sentences
    Summary · context
    In this analysis, the correlation between changes from baseline in fasting intact serum procollagen type I N propeptide (PINP) and serum CTX at 1, 3, 6, and 12 mo and percent increase from baseline in BMD at 12 mo in men from the randomized phase 3 ATOM study (NCT03512262) were evaluated using Pearson's correlation coefficients.
    Summary · context
    Results in men were compared to 12-mo results for women from the ACTIVE study using the z score test after Fisher's Z transformation.

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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