Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis
| Autor: | Judy Maddox, Kenneth G. Saag, Michelle Fan, Jeffrey Petersen, Maria Luisa Brandi, Andrew C. Karaplis, Andreas Grauer, Paul D Meisner, Mattias Lorentzon, Thierry Thomas |
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| Rok vydání: | 2017 |
| Předmět: |
Risk
0301 basic medicine medicine.medical_specialty Abaloparatide Osteoporosis Romosozumab 030209 endocrinology & metabolism Lower risk Fractures Bone 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Double-Blind Method Bone Density Romosozumab Alendronate Fracture Prevention Osteoporosis medicine Humans Cumulative incidence Least-Squares Analysis Osteoporosis Postmenopausal Aged Hip fracture Alendronate Bone Density Conservation Agents business.industry Incidence Antibodies Monoclonal General Medicine medicine.disease Surgery 030104 developmental biology chemistry Cardiovascular Diseases Spinal Fractures Sclerostin Drug Therapy Combination Female Bone Remodeling Osteonecrosis of the jaw business |
| Zdroj: | New England Journal of Medicine. 377:1417-1427 |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejmoa1708322 |
| Popis: | BACKGROUND Romosozumab is a monoclonal antibody that binds to and inhibits sclerostin, increases bone formation, and decreases bone resorption. METHODS We enrolled 4093 postmenopausal women with osteoporosis and a fragility fracture and randomly assigned them in a 1:1 ratio to receive monthly subcutaneous romosozumab (210 mg) or weekly oral alendronate (70 mg) in a blinded fashion for 12 months, followed by open-label alendronate in both groups. The primary end points were the cumulative incidence of new vertebral fracture at 24 months and the cumulative incidence of clinical fracture (nonvertebral and symptomatic vertebral fracture) at the time of the primary analysis (after clinical fractures had been confirmed in ≥330 patients). Secondary end points included the incidences of nonvertebral and hip fracture at the time of the primary analysis. Serious cardiovascular adverse events, osteonecrosis of the jaw, and atypical femoral fractures were adjudicated. RESULTS Over a period of 24 months, a 48% lower risk of new vertebral fractures was observed in the romosozumab-to-alendronate group (6.2% [127 of 2046 patients]) than in the alendronate-to-alendronate group (11.9% [243 of 2047 patients]) (P |
| Databáze: | OpenAIRE |
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