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Study · Randomized controlled trial · 2017

11 results

Effects of Romosozumab Compared With Teriparatide on Bone Density and Mass at the Spine and Hip in Postmenopausal Women With Low Bone Mass.

Genant HK, Engelke K, Bolognese MA, Mautalen C, Brown JP, Recknor C, Goemaere S, Fuerst T, Yang YC, Grauer A, Libanati C

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research20 Sept 2016Cited by 101 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with low bone mass, lumbar spine integral vBMD changes were lower with teriparatide than romosozumab at month 12.

    In plain wordsIn women with low bone mass, total lower spine bone density changes were lower with teriparatide than romosozumab.

    Outcome
    DecreaseLumbar spine integral vBMD
    Study

    n: not reported in source

    Comparator
    Romosozumab
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 µg once daily · subcutaneous · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    One year of treatment with romosozumab significantly increased integral vBMD and BMC at the lumbar spine and total hip from baseline, and compared with placebo and teriparatide (all p < 0.05).
    1 context sentence
    Summary · context
    In additional analyses from this international, randomized study, we now describe the effect of romosozumab on lumbar spine and hip volumetric BMD (vBMD) and BMC at month 12 as assessed by QCT in the subset of participants receiving placebo, s.c. teriparatide (20 µg once daily), and s.c. romosozumab…
  2. 02HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with low bone mass, lumbar spine integral BMC changes were lower with teriparatide than romosozumab at month 12.

    In plain wordsIn women with low bone mass, lower spine bone mineral content changes were lower with teriparatide than romosozumab.

    Outcome
    DecreaseLumbar spine integral BMC
    Study

    n: not reported in source

    Comparator
    Romosozumab
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 µg once daily · subcutaneous · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    One year of treatment with romosozumab significantly increased integral vBMD and BMC at the lumbar spine and total hip from baseline, and compared with placebo and teriparatide (all p < 0.05).
    1 context sentence
    Summary · context
    In additional analyses from this international, randomized study, we now describe the effect of romosozumab on lumbar spine and hip volumetric BMD (vBMD) and BMC at month 12 as assessed by QCT in the subset of participants receiving placebo, s.c. teriparatide (20 µg once daily), and s.c. romosozumab…
  3. 03HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with low bone mass, total hip integral vBMD changes were lower with teriparatide than romosozumab at month 12.

    In plain wordsIn women with low bone mass, total hip bone density changes were lower with teriparatide than romosozumab.

    Outcome
    DecreaseTotal hip integral vBMD
    Study

    n: not reported in source

    Comparator
    Romosozumab
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 µg once daily · subcutaneous · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    One year of treatment with romosozumab significantly increased integral vBMD and BMC at the lumbar spine and total hip from baseline, and compared with placebo and teriparatide (all p < 0.05).
    1 context sentence
    Summary · context
    In additional analyses from this international, randomized study, we now describe the effect of romosozumab on lumbar spine and hip volumetric BMD (vBMD) and BMC at month 12 as assessed by QCT in the subset of participants receiving placebo, s.c. teriparatide (20 µg once daily), and s.c. romosozumab…
  4. 04HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with low bone mass, total hip integral BMC changes were lower with teriparatide than romosozumab at month 12.

    In plain wordsIn women with low bone mass, hip bone mineral content changes were lower with teriparatide than romosozumab.

    Outcome
    DecreaseTotal hip integral BMC
    Study

    n: not reported in source

    Comparator
    Romosozumab
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 µg once daily · subcutaneous · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    One year of treatment with romosozumab significantly increased integral vBMD and BMC at the lumbar spine and total hip from baseline, and compared with placebo and teriparatide (all p < 0.05).
    1 context sentence
    Summary · context
    In additional analyses from this international, randomized study, we now describe the effect of romosozumab on lumbar spine and hip volumetric BMD (vBMD) and BMC at month 12 as assessed by QCT in the subset of participants receiving placebo, s.c. teriparatide (20 µg once daily), and s.c. romosozumab…
  5. 05HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with low bone mass, teriparatide increased trabecular vertebral vBMD by 20.1% from baseline.

    In plain wordsIn women with low bone mass, teriparatide increased spongy spine bone density by 20.1% from baseline.

    Outcome
    IncreaseTrabecular vertebral vBMD versus baseline
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 µg once daily · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Trabecular vertebral vBMD change from baseline
    20.1%
    teriparatide

    Source sentences

    Summary
    Trabecular vertebral vBMD improved significantly and similarly from baseline (p < 0.05) with both romosozumab (18.3%) and teriparatide (20.1%), whereas cortical vertebral vBMD gains were larger with romosozumab compared with teriparatide (13.7% versus 5.7%, p < 0.0001).
    1 context sentence
    Summary · context
    In additional analyses from this international, randomized study, we now describe the effect of romosozumab on lumbar spine and hip volumetric BMD (vBMD) and BMC at month 12 as assessed by QCT in the subset of participants receiving placebo, s.c. teriparatide (20 µg once daily), and s.c. romosozumab…
  6. 06HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with low bone mass, trabecular vertebral vBMD improved similarly with teriparatide and romosozumab.

    In plain wordsIn women with low bone mass, spongy spine bone density improved similarly with teriparatide and romosozumab.

    Outcome
    No significant changeTrabecular vertebral vBMD versus romosozumab
    Study

    n: not reported in source

    Comparator
    Romosozumab
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 µg once daily · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Trabecular vertebral vBMD change from baseline
    20.1%
    teriparatide
    Trabecular vertebral vBMD change from baseline
    18.3%
    romosozumab

    Source sentences

    Summary
    Trabecular vertebral vBMD improved significantly and similarly from baseline (p < 0.05) with both romosozumab (18.3%) and teriparatide (20.1%), whereas cortical vertebral vBMD gains were larger with romosozumab compared with teriparatide (13.7% versus 5.7%, p < 0.0001).
    1 context sentence
    Summary · context
    In additional analyses from this international, randomized study, we now describe the effect of romosozumab on lumbar spine and hip volumetric BMD (vBMD) and BMC at month 12 as assessed by QCT in the subset of participants receiving placebo, s.c. teriparatide (20 µg once daily), and s.c. romosozumab…
  7. 07HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with low bone mass, cortical vertebral vBMD gains were smaller with teriparatide than romosozumab.

    In plain wordsIn women with low bone mass, outer spine bone density gains were smaller with teriparatide than romosozumab.

    Outcome
    DecreaseCortical vertebral vBMD
    Study

    n: not reported in source

    Comparator
    Romosozumab
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 µg once daily · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Cortical vertebral vBMD gain
    5.7%
    teriparatide
    Cortical vertebral vBMD gain
    13.7%
    romosozumab

    Source sentences

    Summary
    Trabecular vertebral vBMD improved significantly and similarly from baseline (p < 0.05) with both romosozumab (18.3%) and teriparatide (20.1%), whereas cortical vertebral vBMD gains were larger with romosozumab compared with teriparatide (13.7% versus 5.7%, p < 0.0001).
    1 context sentence
    Summary · context
    In additional analyses from this international, randomized study, we now describe the effect of romosozumab on lumbar spine and hip volumetric BMD (vBMD) and BMC at month 12 as assessed by QCT in the subset of participants receiving placebo, s.c. teriparatide (20 µg once daily), and s.c. romosozumab…
  8. 08HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with low bone mass, trabecular hip vBMD gains were smaller with teriparatide than romosozumab.

    In plain wordsIn women with low bone mass, spongy hip bone density gains were smaller with teriparatide than romosozumab.

    Outcome
    DecreaseTrabecular hip vBMD
    Study

    n: not reported in source

    Comparator
    Romosozumab
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 µg once daily · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Trabecular hip vBMD gain
    4.2%
    teriparatide
    Trabecular hip vBMD gain
    10.8%
    romosozumab

    Source sentences

    Summary
    Trabecular hip vBMD gains were significantly larger with romosozumab than with teriparatide (10.8% versus 4.2%, p = 0.01), but were similar for cortical vBMD (1.1% versus -0.9%, p = 0.12).
    1 context sentence
    Summary · context
    In additional analyses from this international, randomized study, we now describe the effect of romosozumab on lumbar spine and hip volumetric BMD (vBMD) and BMC at month 12 as assessed by QCT in the subset of participants receiving placebo, s.c. teriparatide (20 µg once daily), and s.c. romosozumab…
  9. 09HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with low bone mass, cortical hip vBMD changes were similar with teriparatide and romosozumab.

    In plain wordsIn women with low bone mass, outer hip bone density changes were similar with teriparatide and romosozumab.

    Outcome
    No significant changeCortical hip vBMD
    Study

    n: not reported in source

    Comparator
    Romosozumab
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 µg once daily · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Cortical hip vBMD change
    −0.9%
    teriparatide
    Cortical hip vBMD change
    1.1%
    romosozumab

    Source sentences

    Summary
    Trabecular hip vBMD gains were significantly larger with romosozumab than with teriparatide (10.8% versus 4.2%, p = 0.01), but were similar for cortical vBMD (1.1% versus -0.9%, p = 0.12).
    1 context sentence
    Summary · context
    In additional analyses from this international, randomized study, we now describe the effect of romosozumab on lumbar spine and hip volumetric BMD (vBMD) and BMC at month 12 as assessed by QCT in the subset of participants receiving placebo, s.c. teriparatide (20 µg once daily), and s.c. romosozumab…
  10. 10HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with low bone mass, cortical spine BMC gains were smaller with teriparatide than romosozumab.

    In plain wordsIn women with low bone mass, outer spine mineral content gains were smaller with teriparatide than romosozumab.

    Outcome
    DecreaseCortical spine BMC
    Study

    n: not reported in source

    Comparator
    Romosozumab
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 µg once daily · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Cortical spine BMC gain
    10.9%
    teriparatide
    Cortical spine BMC gain
    23.3%
    romosozumab

    Source sentences

    Summary
    Cortical BMC gains were larger with romosozumab compared with teriparatide at both the spine (23.3% versus 10.9%, p < 0.0001) and hip (3.4% versus 0.0%, p = 0.03).
    1 context sentence
    Summary · context
    In additional analyses from this international, randomized study, we now describe the effect of romosozumab on lumbar spine and hip volumetric BMD (vBMD) and BMC at month 12 as assessed by QCT in the subset of participants receiving placebo, s.c. teriparatide (20 µg once daily), and s.c. romosozumab…
  11. 11HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with low bone mass, cortical hip BMC gains were smaller with teriparatide than romosozumab.

    In plain wordsIn women with low bone mass, outer hip mineral content gains were smaller with teriparatide than romosozumab.

    Outcome
    DecreaseCortical hip BMC
    Study

    n: not reported in source

    Comparator
    Romosozumab
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 µg once daily · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Cortical hip BMC gain
    0%
    teriparatide
    Cortical hip BMC gain
    3.4%
    romosozumab

    Source sentences

    Summary
    Cortical BMC gains were larger with romosozumab compared with teriparatide at both the spine (23.3% versus 10.9%, p < 0.0001) and hip (3.4% versus 0.0%, p = 0.03).
    1 context sentence
    Summary · context
    In additional analyses from this international, randomized study, we now describe the effect of romosozumab on lumbar spine and hip volumetric BMD (vBMD) and BMC at month 12 as assessed by QCT in the subset of participants receiving placebo, s.c. teriparatide (20 µg once daily), and s.c. romosozumab…

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 2Results postedNCT00896532

Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density

Amgenn = 4193 Jun 2009 to 18 Feb 2016

Low Bone Mineral Density · Postmenopausal Osteoporosis

Trial pageClinicalTrials.govUpdated 22 Sept 2022

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, 02:26 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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