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

NCT05386784 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2024-04-17

No results posted yet for this study

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.

Conditions

  • Postemenopusal Women With Osteopenia

Interventions

DRUG

Raloxifene plus cholecalciferol

Rabone D ( Raloxifene 60mg + Cholecalciferol 800 IU ) 1 Capsule once daily

DRUG

Cholecalciferol

D3 oral base drop, 4 drops once daily (800 IU)

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Yumie Rhee · Department of Internal Medicine, Endocrine Research Institute, Yonsei University College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05386784 on ClinicalTrials.gov