Evaluating raloxifene in postmenopausal Japanese women with osteoporosis or osteopenia

Study Type: Systematic review
OE Level of Evidence: 3
Journal Level of Evidence: N/A
Fifteen studies (7 randomized controlled trials, 8 observational studies) were included in this systematic review to determine the efficacy and safety of raloxifene in treatment of postmenopausal Japanese women suffering from osteoporosis or osteopenia. Qualitatively, majority of studies reporting on pertinent outcomes of interest demonstrated significant increase lumbar spine bone mineral density from baseline, low overall vertebral and non-vertebral fracture incidence, and significant changes from baseline in bone-specific alkaline phosphatase and type 1 collagen N-telopeptide levels during treatment with raloxifene. The quality of Please login to view the rest of this report. Please login to view the rest of this report.
Funding: Industry funded
Sponsor: Eli Lilly Japan K.K.
Conflicts: Company Employee
Why was this study needed now?
Osteoporosis is a major health concern characterized by low bone mass and microarchitectural deterioration of bone tissue. In Japan, population-based estimates approximated that osteoporosis affects between 6.4 and 11 million people. Due to the rapid increase in the aging population, fracture susceptibility among postmenopausal Japanese women is expected to increase. This systematic review looked to investigate raloxifene, a nonsteroidal benzothiophene derivative of the selective estrogen receptor-modulator class, compared to placebo in postmenopausal Japanese with osteoporosis or osteopenia.
What was the principal research question?
Is raloxifene able to safely and effectively prevent or reduce the risk of vertebral and nonvertebral fractures in postmenopausal Japanese women suffering from osteoporosis/osteopenia?
Data Source: MEDLINE and EMBASE were searched for relevant articles published up to May 28, 2013. Reference lists of identified systematic reviews were further manually searched for any studies possibly missed by the electronic search.
Index Terms: The search strategy included: Japan AND (raloxifene OR Evista) AND (osteoporosis OR [fracture OR fracture*] OR bone density).
Study Selection: Eligibility criteria included: Randomized controlled trials or observational studies (prospective and retrospective); conducted in Japan; enrolled postmenopausal women with osteoporosis or osteopenia; included treatment with raloxifene; and reported outcomes related to bone mineral density or fracture incidence. A total of 15 studies (7 randomized controlled trials, 8 observational studies) were selected for final inclusion.
Data Extraction: One researcher extracted study design, participant characteristics, and results, which was then reviewed by all authors. Outcome measures included bone mineral density, incidence of new vertebral or nonvertebral fracture, change in biochemical markers of bone turnover, hip structural geometry, blood-lipid profile, quality of life and pain, and occurrence of adverse events.
Data Synthesis: Quantitative analysis was not performed; instead, outcomes were qualitatively analyzed.
What were the important findings?
What should I remember most?
How will this affect the care of my patients?
The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.