CTRI/2020/10/028767尚未招募4 期
A Prospective, Single-center, Open label, Randomized, Parallel-group, Comparative Clinical Study to Evaluate the Efficacy and Safety of Bio-D3® Plus Vs Shelcal® in the Treatment of Patients with Osteoporosis of Lumbar Spine
Dr Pravin Markade0 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
- 4 期
- 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
- Pms
入排标准
入选标准
- •1.Adult male or female patients aged between 18 to 65 years of age (both ages inclusive).
- •2.Patients diagnosed by DXA as osteoporotic, with BMD score of T <-2.5 in lumbar spine.
- •3.Patients with inadequate levels of Calcium/Calcitriol in the opinion of investigator requiring study treatment.
- •4.Patients willing to use only oral Acetaminophen/Paracetamol (less than or equal to 4 g per day) for aches and pains experienced during the trial.
- •5.Women of childbearing potential must be willing to consistently use an appropriate method of contraception.
- •6.Willingness to give their written informed consent to participate in the study.
- •7.Patients willing to comply with all aspects of the protocol.
排除标准
- •1.Patients who have known history of other bone/metabolic disease (e.g. osteomalacia or osteogenesis imperfecta) and liver cirrhosis.
- •2.Patients who have unstable liver disease (as defined by the known history of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbertâ??s syndrome or asymptomatic gallstones).
- •3.Patients have history of malabsorption syndrome or any gastrointestinal disorders associated with malabsorption.
- •4.Patients with osteomyelitis or osteonecrosis.
- •5.Patient has a history or evidence of lumbar fracture.
- •6.Patients who are known to have history of calcium intolerance.
- •7.Patients who are receiving Ayurvedic, Unani, Herbal, and Homeopathy therapy as stable dose in the past 3 months from screening for treatment of osteoporosis.
- •8.Patients with a known history of hypersensitivity to any of the active or inactive ingredients of the investigational products.
- •9.Patients with history of hypercalcemia, hypercalciuria, or active kidney stone disease.
- •10.Patients receiving glucocorticoids, estrogens, thyroid hormone, parathyroid hormone, fluoride, bisphosphonates, calcitonin, thiazide diuretics, barbiturates, or antiepileptic medications in the past 3 months from screening.
- •11.Patients with known history of fracture in the past 6 months from screening.
- •12.Patients with known history of malignancy
- •13.Patients who received any organ or bone marrow transplantation.
- •14.Any clinical abnormality which, in the opinion of the investigator, will prevent the patient from completing the study or interfere with the interpretation of the study results.
研究者
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