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

Phase 4

Completed

• Conditions: Postemenopusal Women With Osteopenia
• Interventions: Drug: Raloxifene plus cholecalciferol; Drug: Cholecalciferol

• Registration Number: NCT05386784
• Lead Sponsor: Yonsei University

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 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.

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 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.

Study Timeline

• Study Start: 2020-12-16
• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-23
• Primary Completion: 2022-07-14
• Study Completion: 2022-07-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 112

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-score < -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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Raloxifen plus cholecalciferol	Raloxifene plus cholecalciferol	Raloxifene 60mg + Cholecalciferol 800 IU
Cholecalciferol	Cholecalciferol	Cholecalciferol 800 IU

Primary Outcome Measures

Name	Time	Method
BMD lumbar spine	48 weeks	Change in lumbar spine BMD from baseline to 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol

Secondary Outcome Measures

Name	Time	Method
BMD femoral neck and total hip	48 weeks	Change in femoral neck and total hip BMD from baseline to 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol
Bone turnover marker	24 weeks, 48 weeks	Changes in p-CTX and P1NP From Baseline to 24 and 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol
Muscle function	24 weeks, 48 weeks	Changes in muscle fucntion (Handgrip, jump power) From Baseline to 24 and 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol
Lipid profile	24 weeks, 48 weeks	Changes in lipid profile From Baseline to 24 and 48 weeks after the Ralxifene plus cholecalciferol
Quantitative CT	48 weeks	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
EQ-5D test	24 weeks, 48 weeks	Changes in EQ-5D test From Baseline to 24 and 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol
Vertebral fracture	48 weeks	Morphometric Vertebral Fractures Assessed by whole spine x-ray
Bioimpedance analysis	24 weeks, 48 weeks	Changes in bioimpedance analysis From Baseline to 24 and 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of