Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

Summary

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

Timeline

Start

2012-05-04

Primary completion

2017-02-27

Completion

2017-06-29

Outcome

Met primary endpoint

registry analysis (superiority test); Alendronate/Alendronate vs Romosozumab/Alendronate; p <0.001; Odds Ratio (OR) 0.48 (95% CI 0.36 to 0.64); Regression, Logistic NCT01631214 ↗

registry analysis (superiority test); Alendronate/Alendronate vs Romosozumab/Alendronate; p <0.001; Hazard Ratio (HR) 0.73 (95% CI 0.61 to 0.88); Regression, Cox NCT01631214 ↗

release “ARCH study, treatment with EVENITY for 12 months followed by 12 months of alendronate significantly reduced the incidence of new vertebral fracture” amgen.com ↗

Publications

• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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 Sep 16;110(10):2861-2868. doi: 10.1210/clinem/dgae862.
• Lane J, Langdahl B, Stone M, Kurth A, Oates M, Timoshanko J, Wang Z, Libanati C, Cosman F. Romosozumab in patients who experienced an on-study fracture: post hoc analyses of the FRAME and ARCH phase 3 trials. Osteoporos Int. 2024 Jul;35(7):1195-1204. doi: 10.1007/s00198-024-07049-w. Epub 2024 Apr 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alendronic Acid	Small molecule	70 mg	Oral
Subject	Romosozumab	Monoclonal antibody	210 mg	Subcutaneous

Indications