Status:
COMPLETED
Effect of Raloxifene Plus Cholecalciferol and Cholecalciferol Alone on the Bone Mineral Density in Postmenopausal Women With Osteopenia
Lead Sponsor:
Yonsei University
Conditions:
Postemenopusal Women With Osteopenia
Eligibility:
FEMALE
50+ years
Phase:
PHASE4
Brief 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 fr...
Detailed Description
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 d...
Eligibility Criteria
Inclusion
- Postmenopausal women (defined as no menstruation for more than 48 weeks prior to screening and no other pathological or physiological causes. If in doubt, a serum follicle-stimulating hormone (FSH) test may be performed at screening)
- Osteopenia ( -2.5 SD\< T-score \< -1.0 SD in DXA )
Exclusion
- Secondary osteoporosis (Systemic glucocorticoid use, aromatase inhibitor, thyrotoxicosis, hypeparathyroidism, etc)
- Vitamin D deficiency at baseline (25-OH-vitD \<10ng/mL)
- Active cancer treatment
- History of vascular thrombosis
- Bisphosphonate treatment within the last 12months
- Contraindication for Raloxifene according to the SPC
Key Trial Info
Start Date :
December 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2022
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT05386784
Start Date
December 16 2020
End Date
July 14 2022
Last Update
April 17 2024
Active Locations (1)
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1
Yonsei University Health System, Severance Hospital
Seoul, South Korea