Overview

Effect of Raloxifene Plus Cholecalciferol and Cholecalciferol Alone on the Bone Mineral Density in Postmenopausal Women With Osteopenia: an 1-year Randomized Controlled Trial

Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yonsei University
Treatments:
Cholecalciferol
Raloxifene Hydrochloride
Criteria
Inclusion Criteria:

1. 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)

2. Osteopenia ( -2.5 SD< T-scoreā‰¤ -1.0 SD in DXA)

Exclusion Criteria:

1. Secondary osteoporosis (Systemic glucocorticoid use, aromatase inhibitor,
thyrotoxicosis, hypeparathyroidism, etc)

2. Vitamin D deficiency at baseline (25-OH-vitD <10ng/mL)

3. Active cancer treatment

4. History of vascular thrombosis

5. Bisphosphonate treatment within the last 12months

6. Contraindication for Raloxifene according to the SPC