Funded in part by Hanmi Pharmaceutical Co., Ltd
A randomized controlled trial of the effect of raloxifene plus cholecalciferol versus cholecalciferol alone on bone mineral density in postmenopausal women with osteopenia
Shin S, Hong N, Rhee Y
JBMR plus · 7 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Controlled clinical trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Industry funded
- Company
- Hanmi Pharmaceutical Co., Ltd
- Authors
- At least one author declares a financial tie to industry
Based on 1 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2024-05-30 · JBMR Plus · vol. 8 · issue 7 · p. ziae073
- Publisher
- Wiley
- Cited
- 7 citations · more than 88% of similar papers · 2.4× the field average
- References
- 28 works
- Access
- Open access (journal) · CC-BY
- Research areas
- Bone health and osteoporosis research · Bone health and treatments · Bone and Joint Diseases
- Keywords
- Cholecalciferol, Osteopenia, Medicine, Raloxifene, Bone mineral, Vitamin D and neurology, Postmenopausal women, Internal medicine, Endocrinology, Osteoporosis
3 authors
From KR
- Sungjae ShinYonsei University; National Health Insurance Service Ilsan Hospital; National Health Insurance Service
- Namki HongYonsei University
- Yumie Rhee · correspondingYonsei University
Abstract
Raloxifene increases lumbar spine bone mineral density (BMD) and lowers vertebral fracture risk in patients with osteoporosis. However, few prospective clinical trials have studied its efficacy in postmenopausal women with osteopenia. This study investigated the efficacy of raloxifene in postmenopausal women with osteopenia. An investigator-initiated, randomized, open-label, prospective, single-center trial was conducted in 112 postmenopausal women with osteopenia. Osteopenia was defined based on the lowest BMD T-score in the lumbar spine, femoral neck, or total hip (-2.5 P =.005) and attenuated the total hip BMD loss (-0.3% vs. -2.9%, P = .003). The effect of raloxifene on the lumbar spine remained significant after adjustment for age, BMI, baseline BMD T-score, and other covariates (adjusted β: +3.05 vs. VitD, P =.015). In subgroup analysis, the difference in lumbar spine BMD between the RalD and VitD groups was robust in those with severe osteopenia group (lowest T-score ≤ -2.0). Raloxifene plus cholecalciferol significantly improved lumbar spine BMD and attenuated total hip BMD loss compared with cholecalciferol alone, with a more robust effect in severe osteopenia. Clinical trial registration: The trial was registered with ClinicalTrials.gov (NCT05386784).
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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