CTRI/2022/07/043913尚未招募未知
A Prospective, Randomized, Open-label, Parallel-group Investigator-initiated Study to Compare the Efficacy and Safety of Supplementation with Capsules of Calcium Carbonate, Calcitriol in Combination with Magnesium, Soy Isoflavones, and Vitamin K2-7 versus Capsules of Calcium Carbonate, Calcitriol in Combination with Zinc in Postmenopausal Women with Osteoporosis
Dr Hrishikesh Patkar0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Post Menopausal women upto 65 years of age who are diagnosed with osteoporosis.
- •a. Postmenopausal status defined as no vaginal bleeding or spotting for at least 12 consecutive months prior to screening without an alternative medical cause
- •b. Osteoporosis as diagnosed by BMD T-score less than or equal to â??2.50 at the lumbar spine (L1-L4) by DXA
- •2.Patients who require test Product or active comparator for their treatment of osteoporosis as per investigator discretion
- •3.Patients willing to give their written informed consent to participate in the study
- •4.Patients willing to comply with all aspects of the protocol
排除标准
- •1. Patients with known hypersensitivity to any of the study treatment ingredient
- •2. Vitamin D deficiency as indicated by serum levels of 25-hydroxyvitamin D test, Vitamin D <10 ng/mL at screening.
- •3. Malabsorption syndrome or any gastrointestinal disorders that are associated with malabsorption
- •4. Patients with history of hip replacement
- •5. Patients with history of any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, Pagetâ??s disease, Cushingâ??s disease, or hyperprolactinemia
- •Patients with history of severe, untreated hypocalcaemia or hypercalcemia
- •7. Patients with current evidence of hyperparathyroidism or hypoparathyroidism
- •8. Patients with a history of renal calculi
- •9. Any clinical fracture within last 6 months prior to screening
- •10. Patients receiving concomitant medications such as estrogen or estrogen-related compounds, bisphosphonates, fluorides, calcitonin, or any other treatment within the previous 6 months that might have influenced bone mineralization
- •11. Currently receiving treatment for osteoporosis which cannot be stopped or which may interfere with study results or safety of patients participating in the study
- •12. Patients who received any solid organ or bone marrow transplant or on chronic immunosuppression for any reason
- •13. Height, weight or abdominal circumference of patient that has a potential to preclude accurate DXA measurements
- •14. Patients with poorly controlled hypertension or diabetes mellitus
- •15. Any clinically significant acute or chronic illness that could compromise the integrity of study data or affect the analyses if the disease exacerbates during the study or place the subject at risk by participating in the study
- •16. Patients with history of alcohol and/or drug/substance abuse and current significant alcohol consumption which as per investigator judgement make the subject, Ineligible to participate in the study.
- •17. Patients with hyperuremia or known history of gout and other disease related to uric acid accumulation.
- •18. Patients who are immobilized >6 weeks.
- •19. Patients who were a part of any other clinical trial during the past three months prior to screening
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