Raloxifene treatment (60 mg/d) significantly decreased the risk of new clinical vertebral fractures by 68% at 1 year in the Multiple Outcomes of Raloxifene Evaluation (MORE) trial [Arch Int Med 162 (2002): 1140-3], but the effects within the first year are unknown. In MORE, 7705 postmenopausal women were randomized to placebo, or raloxifene at 60 or 120 mg/d. Scheduled vertebral radiographs were obtained at baseline, 2, and 3 years. Other efficacy and safety endpoints were assessed at clinic visits held at 3 and 6 months, and every 6 months thereafter. When patients reported symptoms suggestive of vertebral fracture at or between these clinic visits, radiographs were taken, and if a new adjudicated fracture was found, this was considered as a clinical vertebral fracture. The analyses included all randomized patients with a baseline and at least 1 post-baseline radiograph (n=6828). One woman treated with raloxifene 60 mg/d (n=2259) and 10 women in the placebo group (n=2292) had a clinical vertebral fracture in the first 6 months, resulting in a 90% relative risk (RR) reduction [RR 0.10 (95% CI 0.01, 0.63)]. Similar results were observed with raloxifene 120 mg/d at 6 months. When the raloxifene groups were pooled, a significant (P=0.034) decrease in clinical vertebral fracture risk [RR 0.20 (95% CI 0.03, 0.90)] was seen as early as 3 months. In summary, the risk of new clinical vertebral fractures is significantly reduced with 3 or 6 months of raloxifene therapy.
Disclosure Information:
Faculty Member's Name: Yongming Qu, PhD
Stock Shareholder (directly purchased): Employee of Eli Lilly and Company
See more of Poster Abstracts: Osteoporosis - Treatment
See more of The Sixth International Symposium on Osteoporosis: Current Status and Future Directions