A controlled trial of raloxifene (LY139481) HCl: Impact on bone turnover and serum lipid profile in healthy postmenopausal women
✍ Scribed by Michael W. Draper; David E. Flowers; William J. Huster; Julie A. Neild; Kristine D. Harper; Claude Arnaud
- Publisher
- American Society for Bone and Mineral Research
- Year
- 2009
- Tongue
- English
- Weight
- 701 KB
- Volume
- 11
- Category
- Article
- ISSN
- 0884-0431
No coin nor oath required. For personal study only.
✦ Synopsis
This randomized, double-blind, placebo-controlled, multicenter, 8-week study evaluated short-term effects of raloxifene on bone turnover, serum lipids, and endometrium in healthy, postmenopausal women. A total of 251 women received either placebo, raloxifene HCl 200 or 600 mg/day, or conjugated estrogens (Premarin, 0.625 mg/day). Bone turnover (serum alkaline phosphatase, serum osteocalcin, urinary pyridinoline cross-links, urinary calcium excretion, urinary hydroxyproline) and serum lipids (total serum cholesterol, high-and low-density lipoprotein cholesterol [HDGC and LDL-C]) were evaluated at weeks 0, 2, 4, and 8. Endometrial biopsies were performed at weeks 0 and 8. Treatment groups were compared for each parameter for baseline-to-endpoint changes. The estrogen and raloxifene groups experienced similar decreases in serum alkaline phosphatase (range 10-ll%), serum osteocalcin (range 21-26%), urinary pyridinoline cross-links (range 20-26%), and urinary calcium excretion (range 4572%). These decreases differed significantly compared with placebo-treated subjects for all markers except serum osteocalcin, the raloxifene HCl200 mg group. LDGC decreased significantly in the estrogen and both raloxifene groups (range 5%) compared with placebo-treated subjects. HDL-C increased significantly in the estrogen group (16%) but was unchanged in the raloxifene groups. HDGC:LDGC ratios increased significantly in the estrogen and raloxifene groups (range 9 -2%). Serum cholesterol decreased significantly in both raloxifene groups (range 4-8%) but was unchanged in the estrogen group. Uterine biopsies of raloxifene-treated subjects showed no change in the endometrium during this short-term treatment. Biopsies of the estrogen group showed significant endometrial stimulation. The only adverse event possibly related to raloxifene was vasodilatation (hot flashes) which was most common in the raloxifene HCI 600 mg group. Study results indicate that raloxifene may provide beneficial effects to bone and serum lipids in humans without uterine stimulatory effects. (