CTRI/2024/03/064638招募中4 期
A prospective, multi-centre, open label, phase IV study to evaluate safety and efficacy profile of DenosteRel® in post-menopausal women with osteoporosis
Reliance Life Sciences Pvt Ltd RLS19 个研究点 分布在 1 个国家目标入组 233 人开始时间: 2024年3月29日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 233
- 试验地点
- 19
- 主要终点
- To evaluate safety profile of DenosteRel® in postmenopausal women patients with
研究概览
简要总结
This is prospective, multi-centre, open label, phase IV study to evaluate safety and efficacy profile of DenOsteoRelâ„¢. In this study, a total of 233 postmenopausal women patients with osteoporosis will be enrolled. Out of these 233 patients, a subset of 50 patients who have failed on Bisphosphonate therapy will be enrolled. For this subset of 50 patients only, section 6.2 exclusion criteria no. 14 will not be applicable. Informed consent will be obtained from the participating patients prior to any study specific activity following which patient will be enrolled in the study. Eligible subjects will receive DenOsteoRelâ„¢ at a recommended dose as per prescribing information. Patients will receive **DenOsteoRelâ„¢**as a single subcutaneous injection (60 mg) at baseline and at Month 6 as per prescribing information. Safety and efficacy evaluations will be performed from baseline to end of study visit (visit 6/ Month 9).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
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.Received any solid organ or bone marrow transplant or on chronic 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 interpretation of the results of the study or may prevent the patient from completing the study.
- •Participation in any clinical study of an investigational product within previous 3 months.
结局指标
主要结局
To evaluate safety profile of DenosteRel® in postmenopausal women patients with
时间窗: AE & SAE Will be Captured at Day 1,Day 30 Day 90, Day 180, Day 270 & Withdrawal Visit
osteoporosis
时间窗: AE & SAE Will be Captured at Day 1,Day 30 Day 90, Day 180, Day 270 & Withdrawal Visit
次要结局
- To evaluate efficacy profile of DenosteRel® in postmenopausal women patients with(osteoporosis)
研究者
Dr Ajaykumar Yadav
Reliance Life Sciences Pvt. Ltd. (RLS)
研究点 (19)
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