Clinical trial NCT01631214: Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
Official title: A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Women With Osteoporosis
Keywords: Osteoporosis, Osteoporosis-postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2012-06-29
Enrollment: 4093
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.

Detailed description: In this trial, women were randomly assigned in a 1:1 ratio to receive monthly subcutaneous romosozumab or weekly oral alendronate for 12 months. Randomization was stratified according to age (\<75 vs. ≥75 years). After completion of the double-blind treatment period, all the participants were to receive open-label weekly oral alendronate until the end of the trial, with blinding to the initial treatment assignment maintained.

The primary analysis was performed when clinical fracture events had been confirmed in at least 330 participants and all the participants had completed the month 24 visit. The study was to continue in an event-driven manner until at least 440 participants experienced a nonvertebral fracture or if the superiority of romosozumab was proven for nonvertebral fractures at the primary analysis.

Eligibility criteria: Inclusion Criteria:

Postmenopausal women who meet at least one of the following bone mineral density (BMD) and fracture criteria:

* BMD T-score at the total hip or femoral neck of ≤ -2.50 and EITHER:

  * at least 1 moderate (semiquantitative grade \[SQ\]2) or severe (SQ3) vertebral fracture OR
  * at least 2 mild (SQ1) vertebral fractures OR
* BMD T-score at the total hip or femoral neck of ≤ -2.00 and EITHER:

  * at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR
  * a fracture of the proximal femur that occurred within 3 to 24 months prior to randomization.

Exclusion Criteria:

* History of metabolic or bone disease (except osteoporosis)
* Use of agents affecting bone metabolism
* Vitamin D insufficiency
* History of solid organ or bone marrow transplants
* Hyper- or hypocalcemia
* Hyper- or hypothyroidism
* Hyper- or hypoparathyroidism
* Possible signs of intolerance to alendronate

Primary outcomes:
measure: Percentage of Participants With New Vertebral Fractures Through Month 24
timeFrame: 24 months
measure: Percentage of Participants With a Clinical Fracture at the Primary Analysis
timeFrame: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
Secondary outcomes:
measure: Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis
timeFrame: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
measure: Percentage of Participants With Any Fracture at the Primary Analysis
timeFrame: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
measure: Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24
timeFrame: 24 months
measure: Percentage of Participants With a Major Nonvertebral Fracture at the Primary Analysis
timeFrame: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
measure: Percentage of Participants With a Hip Fracture at the Primary Analysis
timeFrame: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
measure: Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24
timeFrame: 24 months
measure: Percentage of Participants With a Clinical Fracture Through Month 24
timeFrame: 24 months
measure: Percentage of Participants With a Nonvertebral Fracture Through Month 24
timeFrame: 24 months
measure: Percentage of Participants With a Hip Fracture Through Month 24
timeFrame: 24 months
measure: Percentage of Participants With a Clinical Vertebral Fracture Through Month 24
timeFrame: 24 months
measure: Percentage of Participants With a Clinical Fracture Through Month 12
timeFrame: 12 months
measure: Percentage of Participants With New Vertebral Fractures Through Month 12
timeFrame: 12 months
measure: Percentage of Participants With Any Fracture Through Month 12
timeFrame: 12 months
measure: Percentage of Participants With a Nonvertebral Fracture Through Month 12
timeFrame: 12 months
measure: Percentage of Participants With a Hip Fracture Through Month 12
timeFrame: 12 months
measure: Percentage of Participants With a Major Osteoporotic Fracture Through Month 12
timeFrame: 12 months
measure: Percentage of Participants With a Clinical Vertebral Fracture Through Month 12
timeFrame: 12 months
measure: Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 24
timeFrame: Baseline and month 24
measure: Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24
timeFrame: Baseline and month 24
measure: Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at at Month 24
timeFrame: Baseline and month 24
measure: Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12
timeFrame: Baseline and month 12
measure: Percent Change From Baseline in Bone Mineral Density at the Total Hip at Month 12
timeFrame: Baseline and month 12
measure: Percent Change From Baseline in Bone Mineral Density at the Femoral Neck at Month 12
timeFrame: Baseline and month 12
measure: Percent Change From Baseline in Bone Mineral Density of the Lumbar Spine at Month 36
timeFrame: Baseline and month 36
measure: Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 36
timeFrame: Baseline and month 36
measure: Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 36
timeFrame: Baseline and month 36
Other outcomes:
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facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Northwood
country: United Kingdom
facility: Research Site
city: Norwich
country: United Kingdom
facility: Research Site
city: Reading
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Sidcup
country: United Kingdom
facility: Research Site
city: Staffordshire
country: United Kingdom
facility: Research Site
city: Warwick
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427. doi: 10.1056/NEJMoa1708322. Epub 2017 Sep 11.
citation: Cosman F, Lewiecki EM, Ebeling PR, Hesse E, Napoli N, Matsumoto T, Crittenden DB, Rojeski M, Yang W, Libanati C, Ferrari S. T-Score as an Indicator of Fracture Risk During Treatment With Romosozumab or Alendronate in the ARCH Trial. J Bone Miner Res. 2020 Jul;35(7):1333-1342. doi: 10.1002/jbmr.3996. Epub 2020 May 22.
citation: Lau EMC, Dinavahi R, Woo YC, Wu CH, Guan J, Maddox J, Tolman C, Yang W, Shin CS. Romosozumab or alendronate for fracture prevention in East Asian patients: a subanalysis of the phase III, randomized ARCH study. Osteoporos Int. 2020 Apr;31(4):677-685. doi: 10.1007/s00198-020-05324-0. Epub 2020 Feb 11.
citation: Miller PD, Adachi JD, Albergaria BH, Cheung AM, Chines AA, Gielen E, Langdahl BL, Miyauchi A, Oates M, Reid IR, Santiago NR, Vanderkelen M, Wang Z, Yu Z. Efficacy and Safety of Romosozumab Among Postmenopausal Women With Osteoporosis and Mild-to-Moderate Chronic Kidney Disease. J Bone Miner Res. 2022 Aug;37(8):1437-1445. doi: 10.1002/jbmr.4563. Epub 2022 May 20.
citation: Brown JP, Engelke K, Keaveny TM, Chines A, Chapurlat R, Foldes AJ, Nogues X, Civitelli R, De Villiers T, Massari F, Zerbini CAF, Wang Z, Oates MK, Recknor C, Libanati C. Romosozumab improves lumbar spine bone mass and bone strength parameters relative to alendronate in postmenopausal women: results from the Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH) trial. J Bone Miner Res. 2021 Nov;36(11):2139-2152. doi: 10.1002/jbmr.4409. Epub 2021 Aug 10.
citation: McClung MR, Betah D, Leder BZ, Kendler DL, Oates M, Timoshanko J, Wang Z. Romosozumab improves microarchitecture as assessed by tissue thickness-adjusted trabecular bone score in postmenopausal women with osteoporosis. J Bone Miner Res. 2025 Feb 2;40(2):193-200. doi: 10.1093/jbmr/zjae194.
citation: Ferrari S, Betah D, Feldman RG, Langdahl BL, Oates M, Timoshanko J, Wang Z, Dhaliwal R. Romosozumab Improves Tissue Thickness-Adjusted Trabecular Bone Score in Women With Osteoporosis and Diabetes. J Clin Endocrinol Metab. 2025 Jan 24:dgae862. doi: 10.1210/clinem/dgae862. Online ahead of print.