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
| Autor: | Xavier Nogués, Roland Chapurlat, Fabio Massari, Christopher Recknor, Cristiano A. F. Zerbini, Roberto Civitelli, Tony M. Keaveny, Arkadi Chines, Zhenxun Wang, A. Joseph Foldes, Jacques P. Brown, Klaus Engelke, Tobias J. de Villiers, Cesar Libanati, Mary Oates |
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| Rok vydání: | 2021 |
| Předmět: |
musculoskeletal diseases
medicine.medical_specialty Endocrinology Diabetes and Metabolism medicine.medical_treatment Osteoporosis Romosozumab Urology Bone strength Bone Density Humans Medicine Orthopedics and Sports Medicine Quantitative computed tomography Osteoporosis Postmenopausal Reduction (orthopedic surgery) Bone mineral Lumbar Vertebrae Postmenopausal women Alendronate Bone Density Conservation Agents medicine.diagnostic_test business.industry Antibodies Monoclonal medicine.disease Postmenopause Female Lumbar spine business |
| Zdroj: | Journal of Bone and Mineral Research. 36:2139-2152 |
| ISSN: | 1523-4681 0884-0431 |
| Popis: | The Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH) trial (NCT01631214; https://clinicaltrials.gov/ct2/show/NCT01631214) showed that romosozumab for 1 year followed by alendronate led to larger areal bone mineral density (aBMD) gains and superior fracture risk reduction versus alendronate alone. aBMD correlates with bone strength but does not capture all determinants of bone strength that might be differentially affected by various osteoporosis therapeutic agents. We therefore used quantitative computed tomography (QCT) and finite element analysis (FEA) to assess changes in lumbar spine volumetric bone mineral density (vBMD), bone volume, bone mineral content (BMC), and bone strength with romosozumab versus alendronate in a subset of ARCH patients. In ARCH, 4093 postmenopausal women with severe osteoporosis received monthly romosozumab 210 mg sc or weekly oral alendronate 70 mg for 12 months, followed by open-label weekly oral alendronate 70 mg for ≥12 months. Of these, 90 (49 romosozumab, 41 alendronate) enrolled in the QCT/FEA imaging substudy. QCT scans at baseline and at months 6, 12, and 24 were assessed to determine changes in integral (total), cortical, and trabecular lumbar spine vBMD and corresponding bone strength by FEA. Additional outcomes assessed include changes in aBMD, bone volume, and BMC. Romosozumab caused greater gains in lumbar spine integral, cortical, and trabecular vBMD and BMC than alendronate at months 6 and 12, with the greater gains maintained upon transition to alendronate through month 24. These improvements were accompanied by significantly greater increases in FEA bone strength (p |
| Databáze: | OpenAIRE |
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