drugset / Trial / NCT05386784

Effect of Raloxifene Plus Cholecalciferol and Cholecalciferol Alone on the Bone Mineral Density in Postmenopausal Women With Osteopenia

NCT05386784

Phase 4 Completed 112 enrolled Yonsei University
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2020-12-16
Primary completion
2022-07-14
Completion
2022-07-14

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cholecalciferol Other / unclassified 800 iu Oral
Comparator Raloxifene Other / unclassified 60 mg

Indications