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Study · Randomized controlled trial · n = 193 · 2023

16 results

The effects of abaloparatide on hip geometry and biomechanical properties in Japanese osteoporotic patients assessed using DXA-based hip structural analysis: results of the Japanese phase 3 ACTIVE-J trial.

Sone T, Ohnaru K, Sugai T, Yamashita A, Okimoto N, Inoue T, Matsumoto T

Archives of osteoporosis30 Nov 2023Cited by 7 (Europe PMC)

PMID38030806 (opens in a new tab)PMCIDPMC10687120 (opens in a new tab)DOI10.1007/s11657-023-01344-5 (opens in a new tab)PepBankPUB-38030806
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Summary

Daily subcutaneous injection of 80 μg abaloparatide increased bone mineral density in Japanese patients with osteoporosis at high fracture risk in the ACTIVE-J trial. Dual-energy X-ray absorptiometry-based hip structural analysis from ACTIVE-J data showed improved hip geometry and biomechanical properties with abaloparatide compared with placebo.PurposeAbaloparatide (ABL) increased bone mineral density (BMD) in Japanese patients with osteoporosis at high fracture risk in the ACTIVE-J trial. To evaluate the effect of ABL on hip geometry and biomechanical properties, hip structural analysis (HSA) was performed using ACTIVE-J trial data.MethodsHip dual-energy X-ray absorptiometry scans from postmenopausal women and men (ABL, n = 128; placebo, n = 65) at baseline and up to week 78 were analyzed to extract bone geometric parameters at the narrow neck (NN), intertrochanteric region (IT), and proximal femoral shaft (FS). Computed tomography (CT)-based BMD and HSA indices were compared between baseline and week 78.ResultsABL treatment showed increased mean percent change from baseline to week 78 in cortical thickness at the NN (5.3%), IT (5.3%), and FS (2.9%); cross-sectional area at the NN (5.0%), IT (5.0%), and FS (2.6%); cross-sectional moment of inertia at the NN (7.6%), IT (5.1%), and FS (2.5%); section modulus at the NN (7.4%), IT (5.4%), and FS (2.4%); and decreased mean percent change in buckling ratio (BR) at the IT (- 5.0%). ABL treatment showed increased mean percent change in total volumetric BMD (vBMD; 2.7%) and trabecular vBMD (3.2%) at the total hip and decreased mean percent change in BR at femoral neck (- 4.1%) at week 78 vs baseline. All the changes noted here were significant vs placebo (P < 0.050 using t-test).ConclusionA 78-week treatment with ABL showed improvement in HSA parameters associated with hip geometry and biomechanical properties vs placebo.Trial registrationJAPIC CTI-173575.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study16

16 results from studies that gave the peptide. 16 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Japanese osteoporosis patients, abaloparatide increased narrow neck cortical thickness versus placebo.

    In plain wordsIn Japanese osteoporosis patients, abaloparatide increased narrow neck cortical thickness more than placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseNarrow neck cortical thickness
    Study

    n = 193

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

    Measurements

    Cortical thickness change
    5.3%
    narrow neck

    Source sentences

    Summary
    ABL treatment showed increased mean percent change from baseline to week 78 in cortical thickness at the NN (5.3%), IT (5.3%), and FS (2.9%);
    2 context sentences
    Summary · context
    All the changes noted here were significant vs placebo (P < 0.050 using t-test).
    Summary · context
    Hip dual-energy X-ray absorptiometry scans from postmenopausal women and men (ABL, n = 128; placebo, n = 65) at baseline and up to week 78 were analyzed to extract bone geometric parameters at the narrow neck (NN), intertrochanteric region (IT), and proximal femoral shaft (FS).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Japanese osteoporosis patients, abaloparatide increased intertrochanteric cortical thickness versus placebo.

    In plain wordsIn Japanese osteoporosis patients, abaloparatide increased intertrochanteric cortical thickness more than placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseIntertrochanteric cortical thickness
    Study

    n = 193

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

    Measurements

    Cortical thickness change
    5.3%
    intertrochanteric region

    Source sentences

    Summary
    ABL treatment showed increased mean percent change from baseline to week 78 in cortical thickness at the NN (5.3%), IT (5.3%), and FS (2.9%);
    2 context sentences
    Summary · context
    All the changes noted here were significant vs placebo (P < 0.050 using t-test).
    Summary · context
    Hip dual-energy X-ray absorptiometry scans from postmenopausal women and men (ABL, n = 128; placebo, n = 65) at baseline and up to week 78 were analyzed to extract bone geometric parameters at the narrow neck (NN), intertrochanteric region (IT), and proximal femoral shaft (FS).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In Japanese osteoporosis patients, abaloparatide increased femoral shaft cortical thickness versus placebo.

    In plain wordsIn Japanese osteoporosis patients, abaloparatide increased femoral shaft cortical thickness more than placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseFemoral shaft cortical thickness
    Study

    n = 193

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

    Measurements

    Cortical thickness change
    2.9%
    femoral shaft

    Source sentences

    Summary
    ABL treatment showed increased mean percent change from baseline to week 78 in cortical thickness at the NN (5.3%), IT (5.3%), and FS (2.9%);
    2 context sentences
    Summary · context
    All the changes noted here were significant vs placebo (P < 0.050 using t-test).
    Summary · context
    Hip dual-energy X-ray absorptiometry scans from postmenopausal women and men (ABL, n = 128; placebo, n = 65) at baseline and up to week 78 were analyzed to extract bone geometric parameters at the narrow neck (NN), intertrochanteric region (IT), and proximal femoral shaft (FS).
  4. 04HumanRandomized controlled trialEfficacy outcome

    In Japanese osteoporosis patients, abaloparatide increased narrow neck cross-sectional area versus placebo.

    In plain wordsIn Japanese osteoporosis patients, abaloparatide increased narrow neck cross-sectional area more than placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseNarrow neck cross-sectional area
    Study

    n = 193

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

    Measurements

    cross-sectional area change
    5%
    narrow neck

    Source sentences

    Summary
    cross-sectional area at the NN (5.0%), IT (5.0%), and FS (2.6%);
    2 context sentences
    Summary · context
    All the changes noted here were significant vs placebo (P < 0.050 using t-test).
    Summary · context
    Hip dual-energy X-ray absorptiometry scans from postmenopausal women and men (ABL, n = 128; placebo, n = 65) at baseline and up to week 78 were analyzed to extract bone geometric parameters at the narrow neck (NN), intertrochanteric region (IT), and proximal femoral shaft (FS).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In Japanese osteoporosis patients, abaloparatide increased intertrochanteric cross-sectional area versus placebo.

    In plain wordsIn Japanese osteoporosis patients, abaloparatide increased intertrochanteric cross-sectional area more than placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseIntertrochanteric cross-sectional area
    Study

    n = 193

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

    Measurements

    cross-sectional area change
    5%
    intertrochanteric region

    Source sentences

    Summary
    cross-sectional area at the NN (5.0%), IT (5.0%), and FS (2.6%);
    2 context sentences
    Summary · context
    All the changes noted here were significant vs placebo (P < 0.050 using t-test).
    Summary · context
    Hip dual-energy X-ray absorptiometry scans from postmenopausal women and men (ABL, n = 128; placebo, n = 65) at baseline and up to week 78 were analyzed to extract bone geometric parameters at the narrow neck (NN), intertrochanteric region (IT), and proximal femoral shaft (FS).
  6. 06HumanRandomized controlled trialEfficacy outcome

    In Japanese osteoporosis patients, abaloparatide increased femoral shaft cross-sectional area versus placebo.

    In plain wordsIn Japanese osteoporosis patients, abaloparatide increased femoral shaft cross-sectional area more than placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseFemoral shaft cross-sectional area
    Study

    n = 193

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

    Measurements

    cross-sectional area change
    2.6%
    femoral shaft

    Source sentences

    Summary
    cross-sectional area at the NN (5.0%), IT (5.0%), and FS (2.6%);
    2 context sentences
    Summary · context
    All the changes noted here were significant vs placebo (P < 0.050 using t-test).
    Summary · context
    Hip dual-energy X-ray absorptiometry scans from postmenopausal women and men (ABL, n = 128; placebo, n = 65) at baseline and up to week 78 were analyzed to extract bone geometric parameters at the narrow neck (NN), intertrochanteric region (IT), and proximal femoral shaft (FS).
  7. 07HumanRandomized controlled trialEfficacy outcome

    In Japanese osteoporosis patients, abaloparatide increased narrow neck cross-sectional moment of inertia versus placebo.

    In plain wordsIn Japanese osteoporosis patients, abaloparatide increased narrow neck resistance to bending more than placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseNarrow neck cross-sectional moment of inertia
    Study

    n = 193

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

    Measurements

    cross-sectional moment of inertia change
    7.6%
    narrow neck

    Source sentences

    Summary
    cross-sectional moment of inertia at the NN (7.6%), IT (5.1%), and FS (2.5%);
    2 context sentences
    Summary · context
    All the changes noted here were significant vs placebo (P < 0.050 using t-test).
    Summary · context
    Hip dual-energy X-ray absorptiometry scans from postmenopausal women and men (ABL, n = 128; placebo, n = 65) at baseline and up to week 78 were analyzed to extract bone geometric parameters at the narrow neck (NN), intertrochanteric region (IT), and proximal femoral shaft (FS).
  8. 08HumanRandomized controlled trialEfficacy outcome

    In Japanese osteoporosis patients, abaloparatide increased intertrochanteric cross-sectional moment of inertia versus placebo.

    In plain wordsIn Japanese osteoporosis patients, abaloparatide increased intertrochanteric resistance to bending more than placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseIntertrochanteric cross-sectional moment of inertia
    Study

    n = 193

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

    Measurements

    cross-sectional moment of inertia change
    5.1%
    intertrochanteric region

    Source sentences

    Summary
    cross-sectional moment of inertia at the NN (7.6%), IT (5.1%), and FS (2.5%);
    2 context sentences
    Summary · context
    All the changes noted here were significant vs placebo (P < 0.050 using t-test).
    Summary · context
    Hip dual-energy X-ray absorptiometry scans from postmenopausal women and men (ABL, n = 128; placebo, n = 65) at baseline and up to week 78 were analyzed to extract bone geometric parameters at the narrow neck (NN), intertrochanteric region (IT), and proximal femoral shaft (FS).
  9. 09HumanRandomized controlled trialEfficacy outcome

    In Japanese osteoporosis patients, abaloparatide increased femoral shaft cross-sectional moment of inertia versus placebo.

    In plain wordsIn Japanese osteoporosis patients, abaloparatide increased femoral shaft resistance to bending more than placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseFemoral shaft cross-sectional moment of inertia
    Study

    n = 193

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

    Measurements

    cross-sectional moment of inertia change
    2.5%
    femoral shaft

    Source sentences

    Summary
    cross-sectional moment of inertia at the NN (7.6%), IT (5.1%), and FS (2.5%);
    2 context sentences
    Summary · context
    All the changes noted here were significant vs placebo (P < 0.050 using t-test).
    Summary · context
    Hip dual-energy X-ray absorptiometry scans from postmenopausal women and men (ABL, n = 128; placebo, n = 65) at baseline and up to week 78 were analyzed to extract bone geometric parameters at the narrow neck (NN), intertrochanteric region (IT), and proximal femoral shaft (FS).
  10. 10HumanRandomized controlled trialEfficacy outcome

    In Japanese osteoporosis patients, abaloparatide increased narrow neck section modulus versus placebo.

    In plain wordsIn Japanese osteoporosis patients, abaloparatide increased narrow neck section modulus more than placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseNarrow neck section modulus
    Study

    n = 193

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

    Measurements

    section modulus change
    7.4%
    narrow neck

    Source sentences

    Summary
    section modulus at the NN (7.4%), IT (5.4%), and FS (2.4%);
    2 context sentences
    Summary · context
    All the changes noted here were significant vs placebo (P < 0.050 using t-test).
    Summary · context
    Hip dual-energy X-ray absorptiometry scans from postmenopausal women and men (ABL, n = 128; placebo, n = 65) at baseline and up to week 78 were analyzed to extract bone geometric parameters at the narrow neck (NN), intertrochanteric region (IT), and proximal femoral shaft (FS).
  11. 11HumanRandomized controlled trialEfficacy outcome

    In Japanese osteoporosis patients, abaloparatide increased intertrochanteric section modulus versus placebo.

    In plain wordsIn Japanese osteoporosis patients, abaloparatide increased intertrochanteric section modulus more than placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseIntertrochanteric section modulus
    Study

    n = 193

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

    Measurements

    section modulus change
    5.4%
    intertrochanteric region

    Source sentences

    Summary
    section modulus at the NN (7.4%), IT (5.4%), and FS (2.4%);
    2 context sentences
    Summary · context
    All the changes noted here were significant vs placebo (P < 0.050 using t-test).
    Summary · context
    Hip dual-energy X-ray absorptiometry scans from postmenopausal women and men (ABL, n = 128; placebo, n = 65) at baseline and up to week 78 were analyzed to extract bone geometric parameters at the narrow neck (NN), intertrochanteric region (IT), and proximal femoral shaft (FS).
  12. 12HumanRandomized controlled trialEfficacy outcome

    In Japanese osteoporosis patients, abaloparatide increased femoral shaft section modulus versus placebo.

    In plain wordsIn Japanese osteoporosis patients, abaloparatide increased femoral shaft section modulus more than placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseFemoral shaft section modulus
    Study

    n = 193

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

    Measurements

    section modulus change
    2.4%
    femoral shaft

    Source sentences

    Summary
    section modulus at the NN (7.4%), IT (5.4%), and FS (2.4%);
    2 context sentences
    Summary · context
    All the changes noted here were significant vs placebo (P < 0.050 using t-test).
    Summary · context
    Hip dual-energy X-ray absorptiometry scans from postmenopausal women and men (ABL, n = 128; placebo, n = 65) at baseline and up to week 78 were analyzed to extract bone geometric parameters at the narrow neck (NN), intertrochanteric region (IT), and proximal femoral shaft (FS).
  13. 13HumanRandomized controlled trialEfficacy outcome

    In Japanese osteoporosis patients, abaloparatide decreased intertrochanteric buckling ratio versus placebo.

    In plain wordsIn Japanese osteoporosis patients, abaloparatide decreased intertrochanteric buckling ratio more than placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    DecreaseIntertrochanteric buckling ratio
    Study

    n = 193

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

    Measurements

    buckling ratio change
    −5%
    intertrochanteric region

    Source sentences

    Summary
    and decreased mean percent change in buckling ratio (BR) at the IT (- 5.0%).
    2 context sentences
    Summary · context
    All the changes noted here were significant vs placebo (P < 0.050 using t-test).
    Summary · context
    Hip dual-energy X-ray absorptiometry scans from postmenopausal women and men (ABL, n = 128; placebo, n = 65) at baseline and up to week 78 were analyzed to extract bone geometric parameters at the narrow neck (NN), intertrochanteric region (IT), and proximal femoral shaft (FS).
  14. 14HumanRandomized controlled trialEfficacy outcome

    In Japanese osteoporosis patients, abaloparatide increased total hip total volumetric BMD versus placebo.

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

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseTotal hip total volumetric BMD
    Study

    n = 193

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

    Measurements

    Mean percent change from baseline in total hip total volumetric BMD
    2.7%
    abaloparatide, week 78 versus baseline

    Source sentences

    Summary
    ABL treatment showed increased mean percent change in total volumetric BMD (vBMD; 2.7%) and trabecular vBMD (3.2%) at the total hip and decreased mean percent change in BR at femoral neck (- 4.1%) at week 78 vs baseline.
    2 context sentences
    Summary · context
    All the changes noted here were significant vs placebo (P < 0.050 using t-test).
    Summary · context
    Hip dual-energy X-ray absorptiometry scans from postmenopausal women and men (ABL, n = 128; placebo, n = 65) at baseline and up to week 78 were analyzed to extract bone geometric parameters at the narrow neck (NN), intertrochanteric region (IT), and proximal femoral shaft (FS).
  15. 15HumanRandomized controlled trialEfficacy outcome

    In Japanese osteoporosis patients, abaloparatide increased total hip trabecular volumetric BMD versus placebo.

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

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseTotal hip trabecular volumetric BMD
    Study

    n = 193

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

    Measurements

    Mean percent change from baseline in total hip trabecular volumetric BMD
    3.2%
    abaloparatide, week 78 versus baseline

    Source sentences

    Summary
    ABL treatment showed increased mean percent change in total volumetric BMD (vBMD; 2.7%) and trabecular vBMD (3.2%) at the total hip and decreased mean percent change in BR at femoral neck (- 4.1%) at week 78 vs baseline.
    2 context sentences
    Summary · context
    All the changes noted here were significant vs placebo (P < 0.050 using t-test).
    Summary · context
    Hip dual-energy X-ray absorptiometry scans from postmenopausal women and men (ABL, n = 128; placebo, n = 65) at baseline and up to week 78 were analyzed to extract bone geometric parameters at the narrow neck (NN), intertrochanteric region (IT), and proximal femoral shaft (FS).
  16. 16HumanRandomized controlled trialEfficacy outcome

    In Japanese osteoporosis patients, abaloparatide decreased femoral neck buckling ratio versus placebo.

    In plain wordsIn Japanese osteoporosis patients, abaloparatide decreased femoral neck buckling ratio more than placebo.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    DecreaseFemoral neck buckling ratio
    Study

    n = 193

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

    Measurements

    Mean percent change from baseline in femoral neck buckling ratio
    −4.1%
    abaloparatide, week 78 versus baseline

    Source sentences

    Summary
    ABL treatment showed increased mean percent change in total volumetric BMD (vBMD; 2.7%) and trabecular vBMD (3.2%) at the total hip and decreased mean percent change in BR at femoral neck (- 4.1%) at week 78 vs baseline.
    2 context sentences
    Summary · context
    All the changes noted here were significant vs placebo (P < 0.050 using t-test).
    Summary · context
    Hip dual-energy X-ray absorptiometry scans from postmenopausal women and men (ABL, n = 128; placebo, n = 65) at baseline and up to week 78 were analyzed to extract bone geometric parameters at the narrow neck (NN), intertrochanteric region (IT), and proximal femoral shaft (FS).

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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