Treatment of Postmenopausal Women with Osteoporosis or Low Bone Density with Raloxifene

Abstract

Raloxifene, a selective estrogen receptor modulator (SERM), has been shown to improved bone mineral density (BMD) and serum lipid profiles in healthy postmenopausal women. The objective of this study was to examine the effects of raloxifene on BMD, biochemical markers of bone metabolism and serum lipids in postmenopausal women with low bone density or osteoporosis. This Phase II, multicenter, 24-month, double-masked study assessed the efficacy and safety of raloxifene in 129 postmenopausal women (mean age +/- SD: 60.2 +/- 6.7 years) with osteoporosis or low bone density (baseline mean lumbar spine BMD T-score: -2.8). Women were randomly assigned to one of three treatment groups: placebo, 60 mg/day raloxifene-HCl (RLX 60) or 150 mg/day raloxifene-HCL (RLX 150) and concomitantly received 1000 mg/day calcium and 300 U/day vitamin D3. At 24 months, BMD was significantly increased in the lumbar spine (+3.2%), femoral neck (+2.1%), trochanter (+2.7%) and total hip (+1.6%) in the RLX 60 group compared with the placebo group (p < 0.05). The RLX 150 group had increases in BMD similar to those observed with RLX 60. A greater percentage of raloxifene-treated patients, compared with those receiving placebo, had increased BMD (p < 0.05). Serum bone-specific alkaline phosphatase activity, serum osteocalcin, and urinary type I collagen:creatinine ratio were significantly decreased in the RLX-treated groups, compared with the placebo group (p < 0.01). RLX 60 treatment significantly decreased serum levels of triglycerides, and total- and LDL-cholesterol levels (p < 0.01). The rates of patient discontinuation and adverse events were not significantly different among groups. In this study, raloxifene increased bone density, decreased bone turnover, and improved the serum lipid profile with minimal adverse events, and may be a safe and effective treatment for postmenopausal women with osteoporosis or low bone density.

Clinical Significance of 1-year Treatment with Raloxifene on Bone and Lipid Metabolism in Japanese Postmenopausal Women with Osteoporosis

“…However, unexpectedly, the increase rate of BMD of LS was somewhat higher than that observed in the previous studies [1][2][3][4][5][6]. This apparent difference may be partly due to the variability in BMD values resulting from the small sample size in our study, or because about one third of our patients were treated with combined use of RLX and ALF, suggesting that RLX in combination with ALF may be potentially more beneficial for bone health than RLX alone.…”

“…A number of clinical trials [1][2][3][4][5][6] evaluating the effects of RLX on bone, including MORE trial [1], the largest double-blind placebo-controlled one, have clearly demonstrated that RLX improves accelerated bone turnover, increases bone mineral density (BMD) at the lumbar spine (LS) and at the femoral neck (FN), and reduces the risk of new vertebral fractures. In addition, favorable effects on lipid metabolism have also been repeatedly reported in the literature [2,3].…”

“…However, to date, clinical trials for RLX for postmenopausal osteoporosis, including MORE trial, have enrolled primarily Caucasian women [1][2][3][4]. Although osteoporosis is an emerging public health problem in Japan as well, the effects of RLX for Japanese women have not been rigorously examined thus far, except in one clinical trial reported by Morii et al [5].…”

Osteoporosis in Rheumatoid Arthritis

“…Estrogen has a major role in regulation of the bone formation-resorption equilibrium, as it stimulates osteoblast activity 48 . Some SERMs such as raloxifene, act on the bone by slowing bone resorption by the osteoclasts.…”

Effect of Teriparatide {rhPTH(1-34)} on BMD When Given to Postmenopausal Women Receiving Hormone Replacement Therapy

“…Ten million individuals are affected with osteoporosis, and an additional 18 million with low bone mass are at risk. (1) Osteoporosis is more prevalent in postmenopausal white women, (1,2) and it is a preventable disease of menopause. (3) Bone resorption and formation is at equilibrium before menopause, and after menopause, resorption increases, resulting in bone loss.…”