CTRI/2024/03/064638招募中4 期
A prospective, multi-centre, open label, phase IV studyto evaluate safety and efficacy profile of DenosteRel® inpost-menopausal women with osteoporosis - NA
Reliance Life Sciences Pvt Ltd RLS0 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
- 招募中
- 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.Postmenopausal ambulatory woman =75 years of age (post menopausal phase of 5 years or more).
- •2.Patients with BMD value consistent with a T-score between -2.5 to -4.0 at either lumbar spine or hip.
- •3.Able to understand the study procedures and the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements.
排除标准
- •1.Patients with any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings, Paget’s disease, Cushing’s disease or Hyperpolactinemia
- •2.Patients with severe, untreated hypocalcaemia or hypercalcemia
- •3.Patients with Vitamin D deficiency; Vitamin D supplements will be permitted and patient can be retested for Vitamin D.
- •4.Current hyperparathyroidism or hypoparathyroidism
- •5.Uncontrolled Hyperthyroidism or hypothyroidism except patients on stable thyroid hormone replacement therapy for last one year
- •6.Any clinical fracture within last 6 months prior to screening and/or any vertebral fracture on screening spinal X-ray
- •7.Prior use of Denosumab; hypersensitivity to the Denosumab or any of the excipients
- •8.Patients with prior history or current evidence of osteomyelitis or osteonecrosis of the jaw, active dental or jaw condition which requires oral surgery, planned invasive dental procedure or non-healed dental or oral surgery.
- •9.Receivedanysolidorganorbonemarrowtransplantoronchronic immunosuppression for any reason
- •10.History of malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5-years.
- •11.Height, weight or girth that has a potential to preclude accurate DEXA measurements
- •13.Administration of fluoride (except for dental treatment), or strontium ranelate within last one year
- •14.Administration of IV bisphosphonate, cumulative use of oral bisphosphonates (= 1 month) within last 6 months; or any use of oral bisphosphonate within last 3 months ( except for the subset of 50 patients who will be enrolled based on treatment failure with bisphosphonate).
- •15.Administration of any of the following treatments within 6 weeks prior to screening: Anabolic steroid or testosterone, androgen deprivation therapy, parathyroid hormone analogue, calcitonin, calcitriol, vitamin D derivatives (Vitamin D contained in supplements or multivitamins will be permitted) or other bone active drugs including anticonvulsants and heparin
- •16.Chronic systemic ketoconazole, chronic systemic corticosteroid, ACTH, cinacalcet, aluminium, lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone agonists within 6 weeks prior to screening
- •17.History of Rheumatoid arthritis
- •18.History of malabsorption syndrome or any gastrointestinal disorders associated with malabsorption.
- •19.Patients who are HIV, HBsAg, HCV test positive.
- •20.History of alcohol or substance abuse within the last 12-months which the Investigator believes would interfere with understanding or completing the study.
- •21.History of myocardial infarction or stroke within 6 months prior to enrolment or any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study: uncontrolled hypertension, unstable angina; congestive heart failure (= grade 2), cardiac arrhythmia, clinically significant peripheral vascular disease; uncontrolled diabetes
- •22.History or presence of any medical or psychiatric condition or disease, physical examination finding, clinical laboratory finding or any other condition that in the opinion of the Investigator, may place the patient at unacceptable risk for study participation or that might affect the interpreta
研究者
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