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

NCT ID: NCT05386784

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-16
• Study Completion Date: 2022-07-14

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.

Conditions

Postemenopusal Women With Osteopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Raloxifen plus cholecalciferol

Raloxifene 60mg + Cholecalciferol 800 IU

Group Type: ACTIVE_COMPARATOR

Raloxifene plus cholecalciferol

Intervention Type: DRUG

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

Cholecalciferol

Cholecalciferol 800 IU

Group Type: ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type: DRUG

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

Interventions

Raloxifene plus cholecalciferol

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

Intervention Type: DRUG

Cholecalciferol

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

Intervention Type: DRUG

Other Intervention Names

Rabone D; D3 base oral drop

Eligibility 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-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

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yumie Rhee

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Endocrine Research Institute, Yonsei University College of Medicine

Locations

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Countries

South Korea

References

Shin S, Hong N, Rhee Y. A randomized controlled trial of the effect of raloxifene plus cholecalciferol versus cholecalciferol alone on bone mineral density in postmenopausal women with osteopenia. JBMR Plus. 2024 May 30;8(7):ziae073. doi: 10.1093/jbmrpl/ziae073. eCollection 2024 Jul.

Reference Type: DERIVED

PMID: 38939828 (View on PubMed)

Other Identifiers

4-2020-0977

Identifier Type: -

Identifier Source: org_study_id