Arzoxifene versus raloxifene: effect on bone and safety parameters in postmenopausal women with osteoporosis

• Published in: Osteoporosis international 2012-03, Vol.23 (3), p.1091-1101
• Main Authors: Kendler, D. L., Palacios, S., Cox, D. A., Stock, J., Alam, J., Dowsett, S. A., Zanchetta, J.
• Format: Article
• Language: English
• Subjects: Absorptiometry, Photon - methods; Aged; Bone density; Bone Density - drug effects; Bone Density Conservation Agents - adverse effects; Bone Density Conservation Agents - pharmacology; Bone Density Conservation Agents - therapeutic use; Bone mineral density; Bone Remodeling - drug effects; Bone turnover; Bronchitis; Calcium; Cancer; Comparative studies; Double-Blind Method; Drug therapy; Dual energy X-ray absorptiometry; Endocrinology; Endometrium; Estrogen receptors; Female; Femur Neck - physiopathology; Fractures; Hip; Hip Joint - physiopathology; Hot Flashes - chemically induced; Humans; Hyperplasia; Lumbar Vertebrae - physiopathology; Medicine; Medicine & Public Health; Menopause; Middle Aged; Original Article; Orthopedics; Osteoporosis; Osteoporosis, Postmenopausal - drug therapy; Osteoporosis, Postmenopausal - physiopathology; Patient safety; Piperidines - adverse effects; Piperidines - pharmacology; Piperidines - therapeutic use; Polyps; Post-menopause; Raloxifene; Raloxifene Hydrochloride - adverse effects; Raloxifene Hydrochloride - pharmacology; Raloxifene Hydrochloride - therapeutic use; Rheumatology; Rhinopharyngitis; Spine (lumbar); Thiophenes - adverse effects; Thiophenes - pharmacology; Thiophenes - therapeutic use; Treatment Outcome; Vagina; Vitamin D
• ISSN: 0937-941X; 1433-2965
• DOI: 10.1007/s00198-011-1587-0

Summary Arzoxifene increased bone mineral density and decreased bone turnover to a significantly greater extent than raloxifene. The hot flush incidence was lower with arzoxifene than raloxifene. Introduction To assess the effect of arzoxifene versus raloxifene on change in lumbar spine (LS) bone mineral density (BMD) in postmenopausal women with osteoporosis. Methods In this 12-month study (NEXT trial), participants were randomly assigned to arzoxifene 20 mg/day ( N  = 158) or raloxifene 60 mg/day ( N  = 162). All received daily calcium and vitamin D. Change in LS BMD was assessed by DXA. Secondary objectives included assessment of femoral neck (FN) and total hip BMD, serum bone turnover markers, and safety. Results Treatment groups were similar at baseline (mean age 63 years, mean LS BMD T-score −2.9). At 12 months, the increase in LS BMD with arzoxifene was greater than with raloxifene (+2.75% vs. +1.66%), as was FN and total hip BMD ( P