Effect of Raloxifene Plus Cholecalciferol and Cholecalciferol Alone on the Bone Mineral Density in Postmenopausal Women With Osteopenia
Primary Purpose
Postemenopusal Women With Osteopenia
Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Raloxifene plus cholecalciferol
Cholecalciferol
Sponsored by
About this trial
This is an interventional treatment trial for Postemenopusal Women With Osteopenia
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Yonsei University Health System, Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Raloxifen plus cholecalciferol
Cholecalciferol
Arm Description
Raloxifene 60mg + Cholecalciferol 800 IU
Cholecalciferol 800 IU
Outcomes
Primary Outcome Measures
BMD lumbar spine
Change in lumbar spine BMD from baseline to 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol
Secondary Outcome Measures
BMD femoral neck an total hip
Change in femoral neck and total hip BMD from baseline to 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol
Bone turnover marker
Changes in p-CTX and P1NP From Baseline to Six and twelve months after the Ralxifene plus cholecalciferol
Muscle function
Changes in muscle fucntion (Handgrip, jump power) From Baseline to Six and twelve months after the Ralxifene plus cholecalciferol
Lipid profile
Changes in lipid profile From Baseline to Six and twelve months after the Ralxifene plus cholecalciferol
Vertebral fracture
Morphometric Vertebral Fractures Assessed by whole spine x-ray
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05386784
Brief Title
Effect of Raloxifene Plus Cholecalciferol and Cholecalciferol Alone on the Bone Mineral Density in Postmenopausal Women With Osteopenia
Official Title
Effect of Raloxifene Plus Cholecalciferol and Cholecalciferol Alone on the Bone Mineral Density in Postmenopausal Women With Osteopenia: an 1-year Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2020 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postemenopusal Women With Osteopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Raloxifen plus cholecalciferol
Arm Type
Active Comparator
Arm Description
Raloxifene 60mg + Cholecalciferol 800 IU
Arm Title
Cholecalciferol
Arm Type
Active Comparator
Arm Description
Cholecalciferol 800 IU
Intervention Type
Drug
Intervention Name(s)
Raloxifene plus cholecalciferol
Other Intervention Name(s)
Rabone D
Intervention Description
Rabone D ( Raloxifene 60mg + Cholecalciferol 800 IU ) 1 Capsule once daily
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
D3 base oral drop
Intervention Description
D3 oral base drop, 4 drops once daily (800 IU)
Primary Outcome Measure Information:
Title
BMD lumbar spine
Description
Change in lumbar spine BMD from baseline to 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
BMD femoral neck an total hip
Description
Change in femoral neck and total hip BMD from baseline to 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol
Time Frame
48 weeks
Title
Bone turnover marker
Description
Changes in p-CTX and P1NP From Baseline to Six and twelve months after the Ralxifene plus cholecalciferol
Time Frame
48 weeks
Title
Muscle function
Description
Changes in muscle fucntion (Handgrip, jump power) From Baseline to Six and twelve months after the Ralxifene plus cholecalciferol
Time Frame
48 weeks
Title
Lipid profile
Description
Changes in lipid profile From Baseline to Six and twelve months after the Ralxifene plus cholecalciferol
Time Frame
48 weeks
Title
Vertebral fracture
Description
Morphometric Vertebral Fractures Assessed by whole spine x-ray
Time Frame
48 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yumie Rhee
Phone
82-2-2228-0883
Email
yumie@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yumie Rhee
Organizational Affiliation
Department of Internal Medicine, Endocrine Research Institute, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yumie Rhee
Phone
82-2-2228-0883
Email
yumie@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Raloxifene Plus Cholecalciferol and Cholecalciferol Alone on the Bone Mineral Density in Postmenopausal Women With Osteopenia
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