A Phase 4 interventional study of Raloxifene plus cholecalciferol and Cholecalciferol in Postemenopusal Women With Osteopenia, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Yonsei University · Phase 4, Interventional, and Treatment
Osteoporosis is a very strong predictor of fractures with low BMD, but more than half of osteoporotic fractures actually occur in the osteopenic patient group. Therefore, it is important to prevent fractures by actively evaluating fracture risk even in patients with osteopenia.
Raloxifene is a second-generation SERM agent that inhibits bone resorption and is used for the prevention and treatment of postmenopausal osteoporosis. The clinical effect of raloxifene has already been demonstrated in the Multiple Outcomes of Raloxifene Evaluation (MORE) study, a large-scale RCT, to increase BMD and improve lipid profile. In this study, we aimed to evaluate the efficacy of Raloxifene plus cholecalciferol in postmenopausal women with osteopenia.
Backgroud : Osteoporosis is a powerful predictor of fractures with low BMD, but more than half of osteoporotic fractures occur in osteopenia. Therefore, it is important to start drug treatment after diagnosis of osteoporosis, but it is also important to prevent fractures by actively evaluating the risk of fractures in patients with osteopenia. Raloxifene is a selective oestrogen receptor modulator (SERM) that has beneficial effects on bone and lipid profile and has been approved by the FDA as a treatment to prevent osteoporosis. However, studies on the efficacy of Raloxifene plus cholecalciferol in osteopenia patients lack evidence.
Aim : This study aimed to investigate the efficacy of raloxifene plus cholecalciferol in postmenopausal women with osteopenia.
Methods : A prospective, single-center, randomized, opne label, parallel, intervention study in 112 patients investigating the difference in bone mineral density between raloxifene plus cholecalciferol group and cholecalciferol group. Study participants are randomly assigned using the R procedure in a 1:1 ratio at enrollment. Each participant takes raloxifene plus cholecalciferol or cholecalciferol for 48 weeks. All participants were tested for bone turnover markers, routine chemistry, and lipid profile at baseline and 6-month intervals. In addition, at baseline and 48 weeks, DXA, whole spine x-ray, quantitative CT, bioimpedance analysis, muscle function test (handgrip test, jump power), and EQ-5D test.
Perspectives : More than half of osteoporotic fractures occur in patients with osteopenia. This study will confirm the effect of Raloxifene plus cholecalciferol on bone density and show changes in muscle function and lipid metabolism. Through this, early and active treatment can be suggested as a new guideline for preventing osteoporosis and osteoporotic fractures in postmenopausal women with osteopenia.
470 studies on the registry are indexed under Bone Diseases, Metabolic; 71 are open to participants now.
This study's enrollment of 112 is above the median of 60 across 359 interventional studies indexed under Bone Diseases, Metabolic.
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Exclusion Criteria:
Raloxifene 60mg + Cholecalciferol 800 IU
Drug: Raloxifene plus cholecalciferol
Cholecalciferol 800 IU
Drug: Cholecalciferol
Rabone D ( Raloxifene 60mg + Cholecalciferol 800 IU ) 1 Capsule once daily
Also known as: Rabone D
D3 oral base drop, 4 drops once daily (800 IU)
Also known as: D3 base oral drop
BMD lumbar spine
Change in lumbar spine BMD from baseline to 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol
Time frame: 48 weeks
BMD femoral neck and total hip
Change in femoral neck and total hip BMD from baseline to 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol
Time frame: 48 weeks
Bone turnover marker
Changes in p-CTX and P1NP From Baseline to 24 and 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol
Time frame: 24 weeks, 48 weeks
Muscle function
Changes in muscle fucntion (Handgrip, jump power) From Baseline to 24 and 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol
Time frame: 24 weeks, 48 weeks
Lipid profile
Changes in lipid profile From Baseline to 24 and 48 weeks after the Ralxifene plus cholecalciferol
Time frame: 24 weeks, 48 weeks
Vertebral fracture
Morphometric Vertebral Fractures Assessed by whole spine x-ray
Time frame: 48 weeks
Quantitative CT
Change in quantitative CT from baseline to 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol Morphometric Vertebral Fractures Assessed by whole spine x-ray Baseline to 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol
Time frame: 48 weeks
Bioimpedance analysis
Changes in bioimpedance analysis From Baseline to 24 and 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol
Time frame: 24 weeks, 48 weeks
EQ-5D test
Changes in EQ-5D test From Baseline to 24 and 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol
Time frame: 24 weeks, 48 weeks
Plan to share: No
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