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Completed

NCT Number: NCT05386784

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

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.

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Key information

Conditions

Postemenopusal Women With Osteopenia

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Raloxifene plus cholecalciferol

Drug

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

Other names: Rabone D

Cholecalciferol

Drug

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

Other names: D3 base oral drop

Primary outcomes

  1. BMD lumbar spine

    Time frame: 48 weeks

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

Secondary outcomes

  1. BMD femoral neck and total hip

    Time frame: 48 weeks

    Change in femoral neck and total hip BMD from baseline to 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol

  2. Bone turnover marker

    Time frame: 24 weeks, 48 weeks

    Changes in p-CTX and P1NP From Baseline to 24 and 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol

  3. Muscle function

    Time frame: 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

  4. Lipid profile

    Time frame: 24 weeks, 48 weeks

    Changes in lipid profile From Baseline to 24 and 48 weeks after the Ralxifene plus cholecalciferol

  5. Vertebral fracture

    Time frame: 48 weeks

    Morphometric Vertebral Fractures Assessed by whole spine x-ray

  6. Quantitative CT

    Time frame: 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

  7. Bioimpedance analysis

    Time frame: 24 weeks, 48 weeks

    Changes in bioimpedance analysis From Baseline to 24 and 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol

  8. EQ-5D test

    Time frame: 24 weeks, 48 weeks

    Changes in EQ-5D test From Baseline to 24 and 48 weeks after the Ralxifene plus cholecalciferol vs cholecalciferol

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 23, 2022
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.