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Study · Randomized controlled trial · n = 406 · 2022

6 results

Proximal Femur Responses to Sequential Therapy With Abaloparatide Followed by Alendronate in Postmenopausal Women With Osteoporosis by 3D Modeling of Hip Dual-Energy X-Ray Absorptiometry (DXA).

Winzenrieth R, Kostenuik P, Boxberger J, Wang Y, Humbert L

JBMR plus10 Mar 2022Cited by 8 (Europe PMC)

Summary

Previous subgroup analyses from the ACTIVE trial in women with postmenopausal osteoporosis (NCT01343004) using three-dimensional (3D)-processing of dual X-ray absorptiometry (DXA) scans indicated greater increases in total hip cortical volumetric bone mineral density (Ct.vBMD) and estimated indices of hip strength following 18 months of abaloparatide (ABL) versus placebo or teriparatide. The current post hoc analyses describe hip 3D-DXA data for ACTIVExtend (NCT01657162), in which 18 months of ABL followed by 24 months of alendronate (ABL/ALN) increased hip and spine areal BMD (aBMD) and reduced fracture risk versus placebo (PBO) followed by ALN (PBO/ALN). In an ACTIVExtend subgroup (ABL/ALN, n = 204; PBO/ALN, n = 202), hip DXA scans retrospectively underwent 3D modeling via 3D-Shaper software. Changes from baseline in cortical and trabecular compartments were calculated for total hip and hip subregions (femoral neck, trochanter, and shaft). Estimated strength indices comprising cross-sectional moment of inertia, section modulus, and buckling ratio were calculated for each hip subregion. Correlations between bone turnover marker levels at the time of alendronate initiation and subsequent BMD gains with alendronate were also investigated within each group. Total hip trabecular and cortical 3D-DXA parameters increased from baseline in both groups (all p p < 0.001). Strength indices in the ABL/ALN group improved in all subregions versus baseline (all p p < 0.02). In the ABL/ALN group, collagen type I N-terminal propeptide (P1NP) levels at the time of alendronate initiation correlated with subsequent percent changes in all 3D-DXA parameters with 24 months of alendronate therapy. In conclusion, sequential ABL/ALN or PBO/ALN treatment improves trabecular and cortical 3D-DXA parameters at the hip, as well as strength indices of hip subregions, with greater increases with ABL/ALN versus PBO/ALN. © 2022 Radius Health, Inc. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In women with osteoporosis, prior abaloparatide followed by alendronate increased total hip trabecular vBMD more than placebo followed by alendronate.

    In plain wordsIn women with osteoporosis, abaloparatide then alendronate increased hip trabecular bone density more than placebo then alendronate.

    Outcome
    IncreaseTotal hip trabecular volumetric BMD
    Study

    n = 406

    Comparator
    Placebo followed by alendronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · 18 monthsAs given in this study (human).

    Measurements

    Mean percent increase in total hip trabecular vBMD
    10.87%
    ABL/ALN
    Mean percent increase in total hip trabecular vBMD
    4.3%
    PBO/ALN

    Source sentences

    Summary
    Total hip trabecular and cortical 3D-DXA parameters increased from baseline in both groups (all p p < 0.001).
    1 context sentence
    Summary · context
    In an ACTIVExtend subgroup (ABL/ALN, n = 204; PBO/ALN, n = 202), hip DXA scans retrospectively underwent 3D modeling via 3D-Shaper software.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In women with osteoporosis, prior abaloparatide followed by alendronate increased total hip cortical thickness more than placebo followed by alendronate.

    In plain wordsIn women with osteoporosis, abaloparatide then alendronate increased hip cortical thickness more than placebo then alendronate.

    Outcome
    IncreaseTotal hip cortical thickness
    Study

    n = 406

    Comparator
    Placebo followed by alendronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · 18 monthsAs given in this study (human).

    Measurements

    Mean percent increase in total hip cortical thickness
    2.32%
    ABL/ALN
    Mean percent increase in total hip cortical thickness
    1.14%
    PBO/ALN

    Source sentences

    Summary
    Total hip trabecular and cortical 3D-DXA parameters increased from baseline in both groups (all p p < 0.001).
    1 context sentence
    Summary · context
    In an ACTIVExtend subgroup (ABL/ALN, n = 204; PBO/ALN, n = 202), hip DXA scans retrospectively underwent 3D modeling via 3D-Shaper software.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In women with osteoporosis, prior abaloparatide followed by alendronate increased total hip cortical vBMD more than placebo followed by alendronate.

    In plain wordsIn women with osteoporosis, abaloparatide then alendronate increased hip cortical bone density more than placebo then alendronate.

    Outcome
    IncreaseTotal hip cortical volumetric BMD
    Study

    n = 406

    Comparator
    Placebo followed by alendronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · 18 monthsAs given in this study (human).

    Measurements

    Mean percent increase in total hip cortical vBMD
    3.41%
    ABL/ALN
    Mean percent increase in total hip cortical vBMD
    1.86%
    PBO/ALN

    Source sentences

    Summary
    Total hip trabecular and cortical 3D-DXA parameters increased from baseline in both groups (all p p < 0.001).
    1 context sentence
    Summary · context
    In an ACTIVExtend subgroup (ABL/ALN, n = 204; PBO/ALN, n = 202), hip DXA scans retrospectively underwent 3D modeling via 3D-Shaper software.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In women with osteoporosis, prior abaloparatide followed by alendronate increased total hip cortical surface BMD more than placebo followed by alendronate.

    In plain wordsIn women with osteoporosis, abaloparatide then alendronate increased hip cortical surface bone density more than placebo then alendronate.

    Outcome
    IncreaseTotal hip cortical surface BMD
    Study

    n = 406

    Comparator
    Placebo followed by alendronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · 18 monthsAs given in this study (human).

    Measurements

    Mean percent increase in total hip cortical surface BMD
    5.82%
    ABL/ALN
    Mean percent increase in total hip cortical surface BMD
    3%
    PBO/ALN

    Source sentences

    Summary
    Total hip trabecular and cortical 3D-DXA parameters increased from baseline in both groups (all p p < 0.001).
    1 context sentence
    Summary · context
    In an ACTIVExtend subgroup (ABL/ALN, n = 204; PBO/ALN, n = 202), hip DXA scans retrospectively underwent 3D modeling via 3D-Shaper software.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In women with osteoporosis, abaloparatide followed by alendronate improved strength indices in all subregions versus placebo followed by alendronate.

    In plain wordsIn women with osteoporosis, abaloparatide then alendronate improved hip strength indices more than placebo then alendronate.

    Outcome
    Direction not reportedHip subregion strength indices
    Study

    n = 406

    Comparator
    Placebo followed by alendronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · 18 monthsAs given in this study (human).

    Source sentences

    Summary
    Strength indices in the ABL/ALN group improved in all subregions versus baseline (all p p < 0.02).
    1 context sentence
    Summary · context
    In an ACTIVExtend subgroup (ABL/ALN, n = 204; PBO/ALN, n = 202), hip DXA scans retrospectively underwent 3D modeling via 3D-Shaper software.

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. 06HumanNot a test of Abaloparatide (Tymlos) aloneObservational studyOther

    In women receiving abaloparatide then alendronate, P1NP at alendronate initiation correlated with subsequent changes in all 3D-DXA parameters.

    In plain wordsIn women receiving abaloparatide then alendronate, P1NP levels were linked to later changes in all measured bone parameters.

    Outcome
    Direction not reportedP1NP correlation with subsequent 3D-DXA changes
    Study

    n = 204

    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    In the ABL/ALN group, collagen type I N-terminal propeptide (P1NP) levels at the time of alendronate initiation correlated with subsequent percent changes in all 3D-DXA parameters with 24 months of alendronate therapy.
    1 context sentence
    Summary · context
    In an ACTIVExtend subgroup (ABL/ALN, n = 204; PBO/ALN, n = 202), hip DXA scans retrospectively underwent 3D modeling via 3D-Shaper software.

    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

Terms as the source lists them.

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