Fractures in women treated with raloxifene or alendronate: a retrospective database analysis

Abstract

BackgroundRaloxifene and alendronate are anti-resorptive therapies approved for the prevention and treatment of postmenopausal osteoporosis. Raloxifene is also indicated to reduce the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk of invasive breast cancer. A definitive study comparing the fracture effectiveness and rate of breast cancer for raloxifene and alendronate has not been published. The purpose of this retrospective cohort study was to evaluate fracture and breast cancer rates among patients treated with raloxifene or alendronate.MethodsFemales ≥45 years who initiated raloxifene or alendronate in 1998–2006 Truven Health Analytics MarketScan® Databases, had continuous enrollment 12 months prior to and at least 12 months after the index date, and had a treatment medication possession ratio ≥80% were included in this study. Rates of vertebral and nonvertebral fractures and breast cancer during 1, 3, 5, 6, 7, and 8 years of treatment with raloxifene or alendronate were evaluated. Fracture rates were adjusted for potential treatment bias using inverse probability of treatment weights. Multivariate hazard ratios were estimated for vertebral and nonvertebral fractures.ResultsRaloxifene patients had statistically significantly lower rates of vertebral fractures in 1, 3, 5, and 7 years and for nonvertebral fractures in 1 and 5 years. There were no statistically significant differences in the adjusted fracture rates between raloxifene and alendronate cohorts, except in the 3-year nonvertebral fracture rates where raloxifene was higher. Multivariate hazard ratios of raloxifene versus alendronate cohorts were not significantly different for vertebral and nonvertebral fracture in 1, 3, 5, 6, 7, and 8 years. Unweighted and weighted breast cancer rates were lower among raloxifene recipients.ConclusionsPatients treated with alendronate and raloxifene had similar adjusted fracture rates in up to 8 years of adherent treatment, and raloxifene patients had lower breast cancer rates.

Raloxifene Prevents Early Periprosthetic Bone Loss for Postmenopausal Women after Uncemented Total Hip Arthroplasty: A Randomized Placebo‐Controlled Clinical Trial

“…These side effects limit its use in some particular populations. Previous studies demonstrated that raloxifene had statistically significantly lower 18 or similar rates 12,19 of fractures due to decreased BMD in comparison with bisphosphonates. Ellewellyn G. indicated that patients in the raloxifene group believed that their QoL had improved more and had higher treatment satisfaction than patients in the bisphosphonate group 12 .…”

“…Considerable attention has been paid to bisphosphonates. This drug benefits the preservation of periprosthetic bone for postmenopausal osteoporosis 17,18 . Although bisphosphonates are safe drugs in most cases, they have numerous side effects, such as gastrointestinal disturbances, arthralgia, elevated erythrocyte sedimentation rate and C-reactive protein, and flu-like illness with symptoms of fatigue, fever, chills, malaise, and myalgia 17 .…”

“…In the present study, scores related to women's QoL at all time points in the treatment group were significantly better than their postoperative counterparts in the control group. Raloxifene can improve postmenopausal women's QoL by relieving symptoms, including aching joints and muscles, sleep disturbance, and mental problems 12,13,18 . These positive effects, such as the unique advantages of SERM, cannot be replaced by bisphosphonates.…”

Antiosteoporosis Effect ofRadix ScutellariaeExtract on Density and Microstructure of Long Bones in Tail-Suspended Sprague-Dawley Rats

“…As a classic antiresorptive biphosphonate, alendronate sodium (ALE) has been frequently prescribed in clinics for the prevention and treatment of postmenopausal osteoporosis [38]. Its role to inhibit normal bone resorption was also confirmed in tail-suspended rats, which resulted in the net bone mass increase [39].…”

Alendronate versus Raloxifene for Postmenopausal Women: A Meta-Analysis of Seven Head-to-Head Randomized Controlled Trials

“…In addition, the adverse effects (AEs) of two agents, which would highly provide reference during clinical decision making, were not thoroughly compared in previous meta-analyses. (b) Recently, a large-scaled retrospective study conducted by Foster et al [14] emphasized that after adherent treatment there was a similar risk reduction for the both drugs in both vertebral and nonvertebral fractures of women up to 8 years, which was inconsistent with the previous prospective evidence [6, 12, 13]. (c) There were emerging head-to-head RCTs to evaluate the comparative effectiveness of the two agents, the results of which were mainly limited by the small sample size but those available comparative data should be well summarized and taken into consideration [15–21].…”