Data from a recent study found that treatment with the selective estrogen receptor modulator (SERM) raloxifene was associated with greater preservation of body weight and body mass index (BMI) as well as preservation of increased lumbar spine bone mineral density (BMD) in postmenopausal women.1
Raloxifene is a well-studied, safe, and effective SERM treatment option that inhibits bone resorption and reduces the risk of vertebral fracture in postmenopausal women.2 It has also been associated with a reduction in the risk of breast cancer.3 Raloxifene is an option for the treatment of osteoporosis in postmenopausal women who cannot tolerate bisphosphonates or who are at high risk for invasive breast cancer.
In a meta-analysis of 7 trials (4 treatment trials and 3 prevention trials) examining the effects of raloxifene vs placebo on BMD, raloxifene increased BMD of the lumbar spine (weighted mean difference [WMD] 1.8; 95% confidence interval [CI], 1.5-2.1) and hip (WMD 2.1; 95% CI, 1.7-2.5) after 2 years of treatment.2 In the Multiple Outcomes of Raloxifene Evaluation (MORE) trial, 7705 postmenopausal women with osteoporosis were randomly assigned to raloxifene (60 or 120 mg) or placebo daily. Lumbar spine and femoral neck BMD increased from 2.0% to 2.7% in the raloxifene groups compared with placebo.3
In a study published in the Journal of Bone and Mineral Metabolism, Urano and colleagues found that raloxifene treatment was further associated with greater preservation of body weight and BMI as well as preservation of increased lumbar spine BMD in postmenopausal women. This trial was a prospective study that looked at the effects of a 5-year course of raloxifene treatment on fractures, body composition, and lumbar spine BMD in Japanese postmenopausal women. Excluded from analysis were those women with secondary osteoporosis (eg, osteopenia secondary to chronic kidney disease or hyperparathyroidism), those taking glucocorticoids or insulin, and those with major osteoporotic fractures during the observation period.
Key findings included a decrease in lumbar spine BMD by 1.59% in the untreated group and an increase in lumbar spine BMD by 3.29% in the raloxifene-treated group, which represented a statistically significant difference. Additionally, BMI decreased by an average of 1.70% in the untreated group and increased by 0.40% in the raloxifene-treated group. Body weight was also noted to be decreased by an average of 3.44% in the control group; however, there was a decrease of 0.99% in the treated group, reflecting another statistically significant difference.
The study had several limitations, including the fact that the treatment group was composed of older women who had a lower BMI at baseline than the control group. Additionally, women with a preexisting diagnosis of osteoporosis at study onset were not assigned to treatment, and the raloxifene dosing of those treated was not specified.
Summary and Clinical Applicability
It is widely known that decreasing body weight and BMI with aging is a risk factor for osteoporosis and the development of fractures. This study has shown that treatment with raloxifene in postmenopausal woman appears to preserve body mass, thus decreasing the risk for further bone loss and future injury secondary to fracture.
1. Urano T, Shiraki M3, Kuroda T, Tanaka S, Uenishi K, Inoue S. Preventive effects of raloxifene treatment on age-related weight loss in postmenopausal women. J Bone Miner Metab. 2016; Jan 11. [Epub ahead of print]
2. Cranney A, Tugwell P, Zytaruk N, et al. Meta-analyses of therapies for postmenopausal osteoporosis. IV. Meta-analysis of raloxifene for the prevention and treatment of postmenopausal osteoporosis. Endocr Rev. 2002;23:524-528.
3. Cummings SR, Eckert S, Krueger KA, et al. The effect of raloxifene on risk of breast cancer in postmenopausal women: results from the MORE randomized trial. Multiple Outcomes of Raloxifene Evaluation. JAMA. 1999;281:2189-2197.