Skip to content

Study · Non-randomized trial · n = 23 · 2021

13 results

Early Effects of Abaloparatide on Bone Formation and Resorption Indices in Postmenopausal Women With Osteoporosis.

Dempster DW, Zhou H, Rao SD, Recknor C, Miller PD, Leder BZ, Annett M, Ominsky MS, Mitlak BH

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research28 Jan 2021Cited by 27 (Europe PMC)

PMID33434314 (opens in a new tab)PMCIDPMC8248188 (opens in a new tab)DOI10.1002/jbmr.4243 (opens in a new tab)PepBankPUB-33434314
Download PDFPubMedAsk about this study
Jump to 13 results

Summary

Anabolic osteoporosis drugs improve bone mineral density by increasing bone formation. The objective of this study was to evaluate the early effects of abaloparatide on indices of bone formation and to assess the effect of abaloparatide on modeling-based formation (MBF), remodeling-based formation (RBF), and overflow MBF (oMBF) in transiliac bone biopsies. In this open-label, single-arm study, 23 postmenopausal women with osteoporosis were treated with 80 μg abaloparatide daily. Subjects received double fluorochrome labels before treatment and before biopsy collection at 3 months. Change in dynamic histomorphometry indices in four bone envelopes were assessed. Median mineralizing surface per unit of bone surface (MS/BS) increased to 24.7%, 48.7%, 21.4%, and 16.3% of total surface after 3 months of abaloparatide treatment, representing 5.5-, 5.2-, 2.8-, and 12.9-fold changes, on cancellous, endocortical, intracortical, and periosteal surfaces (p < .001 versus baseline for all). Mineral apposition rate (MAR) was significantly increased only on intracortical surfaces. Bone formation rate (BFR/BS) was significantly increased on all four bone envelopes. Significant increases versus baseline were observed in MBF on cancellous, endocortical, and periosteal surfaces, for oMBF on cancellous and endocortical surfaces, and for RBF on cancellous, endocortical, and intracortical surfaces. Overall, modeling-based formation (MBF + oMBF) accounted for 37% and 23% of the increase in bone-forming surface on the endocortical and cancellous surfaces, respectively. Changes from baseline in serum biomarkers of bone turnover at either month 1 or month 3 were generally good surrogates for changes in histomorphometric endpoints. In conclusion, treatment with abaloparatide for 3 months stimulated bone formation on cancellous, endocortical, intracortical, and periosteal envelopes in transiliac bone biopsies obtained from postmenopausal women with osteoporosis. These increases reflected stimulation of both remodeling- and modeling-based bone formation, further elucidating the mechanisms by which abaloparatide improves bone mass and lowers fracture risk. © 2021 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study13

12 results from studies that gave the peptide. 12 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In postmenopausal women with osteoporosis, cancellous MS/BS increased to 24.7%, a 5.5-fold change, with abaloparatide versus baseline.

    In plain wordsIn women with osteoporosis, abaloparatide increased cancellous mineralizing surface versus baseline.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseCancellous mineralizing surface
    Study

    n = 23

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 μg daily · 3 monthsAs given in this study (human).

    Measurements

    MS/BS
    24.7%
    cancellous surface
    Fold change
    5.5 fold
    cancellous surface

    Source sentences

    Summary
    Median mineralizing surface per unit of bone surface (MS/BS) increased to 24.7%, 48.7%, 21.4%, and 16.3% of total surface after 3 months of abaloparatide treatment, representing 5.5-, 5.2-, 2.8-, and 12.9-fold changes, on cancellous, endocortical, intracortical, and periosteal surfaces (p < .001 versus baseline for all).
    2 context sentences
    Summary · context
    In this open-label, single-arm study, 23 postmenopausal women with osteoporosis were treated with 80 μg abaloparatide daily.
    Summary · context
    Subjects received double fluorochrome labels before treatment and before biopsy collection at 3 months.
  2. 02HumanNon-randomized trialEfficacy outcome

    In women with osteoporosis, endocortical MS/BS increased to 48.7%, a 5.2-fold change, with abaloparatide versus baseline.

    In plain wordsIn women with osteoporosis, abaloparatide increased endocortical mineralizing surface versus baseline.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseEndocortical mineralizing surface
    Study

    n = 23

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 μg daily · 3 monthsAs given in this study (human).

    Measurements

    MS/BS
    48.7%
    endocortical surface
    Fold change
    5.2 fold
    endocortical surface

    Source sentences

    Summary
    Median mineralizing surface per unit of bone surface (MS/BS) increased to 24.7%, 48.7%, 21.4%, and 16.3% of total surface after 3 months of abaloparatide treatment, representing 5.5-, 5.2-, 2.8-, and 12.9-fold changes, on cancellous, endocortical, intracortical, and periosteal surfaces (p < .001 versus baseline for all).
    2 context sentences
    Summary · context
    In this open-label, single-arm study, 23 postmenopausal women with osteoporosis were treated with 80 μg abaloparatide daily.
    Summary · context
    Subjects received double fluorochrome labels before treatment and before biopsy collection at 3 months.
  3. 03HumanNon-randomized trialEfficacy outcome

    In women with osteoporosis, intracortical MS/BS increased to 21.4%, a 2.8-fold change, with abaloparatide versus baseline.

    In plain wordsIn women with osteoporosis, abaloparatide increased intracortical mineralizing surface versus baseline.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseIntracortical mineralizing surface
    Study

    n = 23

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 μg daily · 3 monthsAs given in this study (human).

    Measurements

    MS/BS
    21.4%
    intracortical surface
    Fold change
    2.8 fold
    intracortical surface

    Source sentences

    Summary
    Median mineralizing surface per unit of bone surface (MS/BS) increased to 24.7%, 48.7%, 21.4%, and 16.3% of total surface after 3 months of abaloparatide treatment, representing 5.5-, 5.2-, 2.8-, and 12.9-fold changes, on cancellous, endocortical, intracortical, and periosteal surfaces (p < .001 versus baseline for all).
    2 context sentences
    Summary · context
    In this open-label, single-arm study, 23 postmenopausal women with osteoporosis were treated with 80 μg abaloparatide daily.
    Summary · context
    Subjects received double fluorochrome labels before treatment and before biopsy collection at 3 months.
  4. 04HumanNon-randomized trialEfficacy outcome

    In women with osteoporosis, periosteal MS/BS increased to 16.3%, a 12.9-fold change, with abaloparatide versus baseline.

    In plain wordsIn women with osteoporosis, abaloparatide increased periosteal mineralizing surface versus baseline.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreasePeriosteal mineralizing surface
    Study

    n = 23

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 μg daily · 3 monthsAs given in this study (human).

    Measurements

    MS/BS
    16.3%
    periosteal surface
    Fold change
    12.9 fold
    periosteal surface

    Source sentences

    Summary
    Median mineralizing surface per unit of bone surface (MS/BS) increased to 24.7%, 48.7%, 21.4%, and 16.3% of total surface after 3 months of abaloparatide treatment, representing 5.5-, 5.2-, 2.8-, and 12.9-fold changes, on cancellous, endocortical, intracortical, and periosteal surfaces (p < .001 versus baseline for all).
    2 context sentences
    Summary · context
    In this open-label, single-arm study, 23 postmenopausal women with osteoporosis were treated with 80 μg abaloparatide daily.
    Summary · context
    Subjects received double fluorochrome labels before treatment and before biopsy collection at 3 months.
  5. 05HumanNon-randomized trialEfficacy outcome

    In women with osteoporosis, abaloparatide significantly increased mineral apposition rate only on intracortical surfaces versus baseline.

    In plain wordsIn women with osteoporosis, abaloparatide significantly increased mineral apposition rate only on intracortical surfaces versus baseline.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseIntracortical mineral apposition rate
    Study

    n = 23

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 μg daily · 3 monthsAs given in this study (human).

    Source sentences

    Summary
    Mineral apposition rate (MAR) was significantly increased only on intracortical surfaces.
    2 context sentences
    Summary · context
    In this open-label, single-arm study, 23 postmenopausal women with osteoporosis were treated with 80 μg abaloparatide daily.
    Summary · context
    Subjects received double fluorochrome labels before treatment and before biopsy collection at 3 months.
  6. 06HumanNon-randomized trialEfficacy outcome

    In women with osteoporosis, abaloparatide significantly increased bone formation rate on all four bone envelopes versus baseline.

    In plain wordsIn women with osteoporosis, abaloparatide increased bone formation rate on all four bone envelopes versus baseline.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseBone formation rate across four envelopes
    Study

    n = 23

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 μg daily · 3 monthsAs given in this study (human).

    Source sentences

    Summary
    Bone formation rate (BFR/BS) was significantly increased on all four bone envelopes.
    2 context sentences
    Summary · context
    In this open-label, single-arm study, 23 postmenopausal women with osteoporosis were treated with 80 μg abaloparatide daily.
    Summary · context
    Subjects received double fluorochrome labels before treatment and before biopsy collection at 3 months.
  7. 07HumanNon-randomized trialEfficacy outcome

    In women with osteoporosis, abaloparatide increased modeling-based formation on cancellous, endocortical, and periosteal surfaces versus baseline.

    In plain wordsIn women with osteoporosis, abaloparatide increased modeling-based formation on cancellous, endocortical, and periosteal surfaces versus baseline.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseModeling-based formation
    Study

    n = 23

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 μg daily · 3 monthsAs given in this study (human).

    Source sentences

    Summary
    Significant increases versus baseline were observed in MBF on cancellous, endocortical, and periosteal surfaces, for oMBF on cancellous and endocortical surfaces, and for RBF on cancellous, endocortical, and intracortical surfaces.
    2 context sentences
    Summary · context
    In this open-label, single-arm study, 23 postmenopausal women with osteoporosis were treated with 80 μg abaloparatide daily.
    Summary · context
    Subjects received double fluorochrome labels before treatment and before biopsy collection at 3 months.
  8. 08HumanNon-randomized trialEfficacy outcome

    In women with osteoporosis, abaloparatide increased overflow modeling-based formation on cancellous and endocortical surfaces versus baseline.

    In plain wordsIn women with osteoporosis, abaloparatide increased overflow modeling-based formation on cancellous and endocortical surfaces versus baseline.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseOverflow modeling-based formation
    Study

    n = 23

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 μg daily · 3 monthsAs given in this study (human).

    Source sentences

    Summary
    Significant increases versus baseline were observed in MBF on cancellous, endocortical, and periosteal surfaces, for oMBF on cancellous and endocortical surfaces, and for RBF on cancellous, endocortical, and intracortical surfaces.
    2 context sentences
    Summary · context
    In this open-label, single-arm study, 23 postmenopausal women with osteoporosis were treated with 80 μg abaloparatide daily.
    Summary · context
    Subjects received double fluorochrome labels before treatment and before biopsy collection at 3 months.
  9. 09HumanNon-randomized trialEfficacy outcome

    In women with osteoporosis, abaloparatide increased remodeling-based formation on cancellous, endocortical, and intracortical surfaces versus baseline.

    In plain wordsIn women with osteoporosis, abaloparatide increased remodeling-based formation on cancellous, endocortical, and intracortical surfaces versus baseline.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseRemodeling-based formation
    Study

    n = 23

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 μg daily · 3 monthsAs given in this study (human).

    Source sentences

    Summary
    Significant increases versus baseline were observed in MBF on cancellous, endocortical, and periosteal surfaces, for oMBF on cancellous and endocortical surfaces, and for RBF on cancellous, endocortical, and intracortical surfaces.
    2 context sentences
    Summary · context
    In this open-label, single-arm study, 23 postmenopausal women with osteoporosis were treated with 80 μg abaloparatide daily.
    Summary · context
    Subjects received double fluorochrome labels before treatment and before biopsy collection at 3 months.
  10. 10HumanNon-randomized trialMechanism

    In women receiving abaloparatide, modeling-based formation including overflow accounted for 37% of increased endocortical bone-forming surface.

    In plain wordsIn women receiving abaloparatide, modeling-based formation including overflow accounted for 37% of increased endocortical bone-forming surface.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableModeling contribution to endocortical bone-forming surface
    Study

    n = 23

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 μg daily · 3 monthsAs given in this study (human).

    Measurements

    Modeling contribution
    37%
    endocortical surface

    Source sentences

    Summary
    Overall, modeling-based formation (MBF + oMBF) accounted for 37% and 23% of the increase in bone-forming surface on the endocortical and cancellous surfaces, respectively.
    2 context sentences
    Summary · context
    In this open-label, single-arm study, 23 postmenopausal women with osteoporosis were treated with 80 μg abaloparatide daily.
    Summary · context
    Subjects received double fluorochrome labels before treatment and before biopsy collection at 3 months.
  11. 11HumanNon-randomized trialMechanism

    In women receiving abaloparatide, modeling-based formation including overflow accounted for 23% of increased cancellous bone-forming surface.

    In plain wordsIn women receiving abaloparatide, modeling-based formation including overflow accounted for 23% of increased cancellous bone-forming surface.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableModeling contribution to cancellous bone-forming surface
    Study

    n = 23

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 μg daily · 3 monthsAs given in this study (human).

    Measurements

    Modeling contribution
    23%
    cancellous surface

    Source sentences

    Summary
    Overall, modeling-based formation (MBF + oMBF) accounted for 37% and 23% of the increase in bone-forming surface on the endocortical and cancellous surfaces, respectively.
    2 context sentences
    Summary · context
    In this open-label, single-arm study, 23 postmenopausal women with osteoporosis were treated with 80 μg abaloparatide daily.
    Summary · context
    Subjects received double fluorochrome labels before treatment and before biopsy collection at 3 months.
  12. 12HumanNon-randomized trialEfficacy outcome

    In women with osteoporosis, abaloparatide did not significantly increase mineral apposition rate on cancellous, endocortical, or periosteal surfaces versus baseline.

    In plain wordsIn women with osteoporosis, abaloparatide did not significantly increase mineral apposition rate on cancellous, endocortical, or periosteal surfaces versus baseline.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    No significant changeNon-intracortical mineral apposition rate
    Study

    n = 23

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    80 μg daily · 3 monthsAs given in this study (human).

    Source sentences

    Summary
    Mineral apposition rate (MAR) was significantly increased only on intracortical surfaces.
    2 context sentences
    Summary · context
    In this open-label, single-arm study, 23 postmenopausal women with osteoporosis were treated with 80 μg abaloparatide daily.
    Summary · context
    Subjects received double fluorochrome labels before treatment and before biopsy collection at 3 months.

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. 13HumanNot a test of Abaloparatide (Tymlos) aloneNon-randomized trialOther

    In women receiving abaloparatide, serum bone-turnover biomarker changes generally reflected histomorphometric changes.

    In plain wordsIn women receiving abaloparatide, serum bone-turnover biomarker changes generally reflected changes in bone measurements.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableBiomarker surrogacy for histomorphometry
    Study

    n = 23

    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    Changes from baseline in serum biomarkers of bone turnover at either month 1 or month 3 were generally good surrogates for changes in histomorphometric endpoints.
    2 context sentences
    Summary · context
    In this open-label, single-arm study, 23 postmenopausal women with osteoporosis were treated with 80 μg abaloparatide daily.
    Summary · context
    Subjects received double fluorochrome labels before treatment and before biopsy collection at 3 months.

    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 postedNCT03710889

Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption

Radius Health, Inc.n = 2320 Sept 2018 to 15 Jul 2020

Osteoporosis, Postmenopausal · Osteoporosis · Osteoporosis Vertebral · Osteoporosis Risk · Osteoporosis Fracture · Osteoporosis Localized to Spine · Osteoporosis, Age-Related · Osteoporosis Senile · Osteoporosis of Vertebrae

Trial pageClinicalTrials.govUpdated 15 Oct 2021

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.

PepBank is a research reference. Talk to a doctor before you use any peptide.