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Study · Randomized controlled trial · 2018

7 results

Abaloparatide is an Effective Treatment Option for Postmenopausal Osteoporosis: Review of the Number Needed to Treat Compared with Teriparatide.

Reginster JY, Hattersley G, Williams GC, Hu MY, Fitzpatrick LA, Lewiecki EM

Calcified tissue international27 Jun 2018Cited by 19 (Europe PMC)

Summary

Abaloparatide (ABL) is a 34-amino acid peptide designed to be a selective activator of the parathyroid hormone receptor type 1 signaling pathway. In the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE), subcutaneous ABL reduced the risk of new vertebral, nonvertebral, clinical, and major osteoporotic fracture compared with placebo and of major osteoporotic fracture compared with teriparatide. To further evaluate the effectiveness of ABL, we calculated the number needed to treat (NNT) to prevent one fracture using ACTIVE data. To estimate the potential effectiveness of ABL in populations at higher fracture risk than in ACTIVE, we calculated NNT for vertebral fracture using reference populations from historical placebo-controlled trials, assuming an 86% relative risk reduction in vertebral fracture with ABL treatment as observed in ACTIVE. NNT was calculated as the reciprocal of the absolute risk reduction in ACTIVE. The projected NNT for ABL in other populations was calculated based on incidence rate (IR) for vertebral fractures in the placebo arms of the FREEDOM (placebo IR 7.2%), FIT-1 (placebo IR 15.0%), and FIT-2 (placebo IR 3.8%) trials. NNT for ABL in ACTIVE was 28 for vertebral, 55 for nonvertebral, 37 for clinical, and 34 for major osteoporotic fracture. NNT for these fracture types for teriparatide in ACTIVE were 30, 92, 59, and 75, respectively. Using placebo IRs from FREEDOM, FIT-1, and FIT-2, projected NNTs for vertebral fracture with ABL were 17, 8, and 31. These data are useful for further evaluating ABL for the treatment of osteoporosis in postmenopausal women.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study7

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women in ACTIVE, the abaloparatide number needed to treat to prevent one vertebral fracture was 28.

    In plain wordsIn ACTIVE, 28 women needed abaloparatide treatment instead of placebo to prevent one vertebral fracture.

    Outcome
    Not applicableVertebral fracture NNT
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Measurements

    NNT
    28 patients
    vertebral fracture

    Source sentences

    Summary
    NNT for ABL in ACTIVE was 28 for vertebral, 55 for nonvertebral, 37 for clinical, and 34 for major osteoporotic fracture.
    2 context sentences
    Summary · context
    To further evaluate the effectiveness of ABL, we calculated the number needed to treat (NNT) to prevent one fracture using ACTIVE data.
    Summary · context
    NNT was calculated as the reciprocal of the absolute risk reduction in ACTIVE.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women in ACTIVE, the abaloparatide number needed to treat to prevent one nonvertebral fracture was 55.

    In plain wordsIn ACTIVE, 55 women needed abaloparatide treatment instead of placebo to prevent one nonvertebral fracture.

    Outcome
    Not applicableNonvertebral fracture NNT
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Measurements

    NNT
    55 patients
    nonvertebral fracture

    Source sentences

    Summary
    NNT for ABL in ACTIVE was 28 for vertebral, 55 for nonvertebral, 37 for clinical, and 34 for major osteoporotic fracture.
    2 context sentences
    Summary · context
    To further evaluate the effectiveness of ABL, we calculated the number needed to treat (NNT) to prevent one fracture using ACTIVE data.
    Summary · context
    NNT was calculated as the reciprocal of the absolute risk reduction in ACTIVE.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women in ACTIVE, the abaloparatide number needed to treat to prevent one clinical fracture was 37.

    In plain wordsIn ACTIVE, 37 women needed abaloparatide treatment instead of placebo to prevent one clinical fracture.

    Outcome
    Not applicableClinical fracture NNT
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Measurements

    NNT
    37 patients
    clinical fracture

    Source sentences

    Summary
    NNT for ABL in ACTIVE was 28 for vertebral, 55 for nonvertebral, 37 for clinical, and 34 for major osteoporotic fracture.
    2 context sentences
    Summary · context
    To further evaluate the effectiveness of ABL, we calculated the number needed to treat (NNT) to prevent one fracture using ACTIVE data.
    Summary · context
    NNT was calculated as the reciprocal of the absolute risk reduction in ACTIVE.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women in ACTIVE, the abaloparatide number needed to treat to prevent one major osteoporotic fracture was 34.

    In plain wordsIn ACTIVE, 34 women needed abaloparatide treatment instead of placebo to prevent one major osteoporotic fracture.

    Outcome
    Not applicableMajor osteoporotic fracture NNT
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Measurements

    NNT
    34 patients
    major osteoporotic fracture

    Source sentences

    Summary
    NNT for ABL in ACTIVE was 28 for vertebral, 55 for nonvertebral, 37 for clinical, and 34 for major osteoporotic fracture.
    2 context sentences
    Summary · context
    To further evaluate the effectiveness of ABL, we calculated the number needed to treat (NNT) to prevent one fracture using ACTIVE data.
    Summary · context
    NNT was calculated as the reciprocal of the absolute risk reduction in ACTIVE.

Studies that did not test the peptide alone3

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. 05Computer modelNot a test of Abaloparatide (Tymlos) aloneIn silicoEfficacy outcome

    In projections using FREEDOM placebo incidence, abaloparatide's vertebral fracture NNT was 17.

    In plain wordsComputer projections using FREEDOM placebo data estimated an abaloparatide vertebral fracture NNT of 17.

    Outcome
    Not applicableProjected vertebral fracture NNT using FREEDOM
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal

    Measurements

    Projected NNT
    17 patients
    FREEDOM

    Source sentences

    Summary
    Using placebo IRs from FREEDOM, FIT-1, and FIT-2, projected NNTs for vertebral fracture with ABL were 17, 8, and 31.
    4 context sentences
    Summary · context
    To estimate the potential effectiveness of ABL in populations at higher fracture risk than in ACTIVE, we calculated NNT for vertebral fracture using reference populations from historical placebo-controlled trials, assuming an 86% relative risk reduction in vertebral fracture with ABL treatment as observed in ACTIVE.
    Summary · context
    The projected NNT for ABL in other populations was calculated based on incidence rate (IR) for vertebral fractures in the placebo arms of the FREEDOM (placebo IR 7.2%), FIT-1 (placebo IR 15.0%), and FIT-2 (placebo IR 3.8%) trials.
    Summary · context
    To further evaluate the effectiveness of ABL, we calculated the number needed to treat (NNT) to prevent one fracture using ACTIVE data.
    Summary · context
    NNT was calculated as the reciprocal of the absolute risk reduction in ACTIVE.

    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. 06Computer modelNot a test of Abaloparatide (Tymlos) aloneIn silicoEfficacy outcome

    In projections using FIT-1 placebo incidence, abaloparatide's vertebral fracture NNT was 8.

    In plain wordsComputer projections using FIT-1 placebo data estimated an abaloparatide vertebral fracture NNT of 8.

    Outcome
    Not applicableProjected vertebral fracture NNT using FIT-1
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal

    Measurements

    Projected NNT
    8 patients
    FIT-1

    Source sentences

    Summary
    Using placebo IRs from FREEDOM, FIT-1, and FIT-2, projected NNTs for vertebral fracture with ABL were 17, 8, and 31.
    4 context sentences
    Summary · context
    To estimate the potential effectiveness of ABL in populations at higher fracture risk than in ACTIVE, we calculated NNT for vertebral fracture using reference populations from historical placebo-controlled trials, assuming an 86% relative risk reduction in vertebral fracture with ABL treatment as observed in ACTIVE.
    Summary · context
    The projected NNT for ABL in other populations was calculated based on incidence rate (IR) for vertebral fractures in the placebo arms of the FREEDOM (placebo IR 7.2%), FIT-1 (placebo IR 15.0%), and FIT-2 (placebo IR 3.8%) trials.
    Summary · context
    To further evaluate the effectiveness of ABL, we calculated the number needed to treat (NNT) to prevent one fracture using ACTIVE data.
    Summary · context
    NNT was calculated as the reciprocal of the absolute risk reduction in ACTIVE.

    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).

  3. 07Computer modelNot a test of Abaloparatide (Tymlos) aloneIn silicoEfficacy outcome

    In projections using FIT-2 placebo incidence, abaloparatide's vertebral fracture NNT was 31.

    In plain wordsComputer projections using FIT-2 placebo data estimated an abaloparatide vertebral fracture NNT of 31.

    Outcome
    Not applicableProjected vertebral fracture NNT using FIT-2
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal

    Measurements

    Projected NNT
    31 patients
    FIT-2

    Source sentences

    Summary
    Using placebo IRs from FREEDOM, FIT-1, and FIT-2, projected NNTs for vertebral fracture with ABL were 17, 8, and 31.
    4 context sentences
    Summary · context
    To estimate the potential effectiveness of ABL in populations at higher fracture risk than in ACTIVE, we calculated NNT for vertebral fracture using reference populations from historical placebo-controlled trials, assuming an 86% relative risk reduction in vertebral fracture with ABL treatment as observed in ACTIVE.
    Summary · context
    The projected NNT for ABL in other populations was calculated based on incidence rate (IR) for vertebral fractures in the placebo arms of the FREEDOM (placebo IR 7.2%), FIT-1 (placebo IR 15.0%), and FIT-2 (placebo IR 3.8%) trials.
    Summary · context
    To further evaluate the effectiveness of ABL, we calculated the number needed to treat (NNT) to prevent one fracture using ACTIVE data.
    Summary · context
    NNT was calculated as the reciprocal of the absolute risk reduction in ACTIVE.

    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.

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

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