CTRI/2024/03/064791尚未招募不适用
A Prospective, Observational, Investigator-initiated Study (IIS) to Investigate the Real-World Effectiveness and Safety of Denosumab in Patients with Osteoporosis due to Chronic Kidney Disease.
Dr Jatin Kothari2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年4月5日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percentage change in BMD at lumbar spine and femur neck by dual x-ray absorptiometry (DEXA)
研究概览
简要总结
This will be a prospective, single arm IIS in dialysis dependent CKD patients, diagnosed with Osteoporosis and receiving Denosumab as per clinical practice. The duration of study will be 24 months (18 months treatment + 6 months follow up). The collected data will be analysed to see the effectiveness and safety profile of denosumab in these patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •(1.)Age greater than 18 years.
- •(2.) Patients with at least 3 months Maintenance Hemodialysis (MHD).
- •(3.) Patients having a history of prior fracture in either the lumbar spine or the proximal femur whose T-score less than −1.0 in the LS and FN, or (4.) T-score -2.5 to -4.0, or (5.) Patients at high risk of bone fracture.
- •Criteria for assigning high risk will be a previous history of fragility fracture, a family history of bone fracture in the proximal femur, or having a risk of bone fracture during the past 10 years of greater than 15% according to the FRAX scale.
- •(6.) Baseline clinically acceptable physical examination.
- •(7.) Stable Electrocardiograph results at screening.
- •(8.) Patients receiving Denosumab as part of routine clinical practice.
排除标准
- •(1.) Hypoparathyroidism, hypocalcemia (albumin adjusted serum Calcium conc.
- •less than 8.5 mg/dl) or Vitamin D deficiency (25-hydroxyvitamin D level less than 30 ng/ml at screening) (2.) Contraindications for receiving denosumab.
- •(3.) Known hypersensitivity to denosumab.
- •(4.) Patients who had been pretreated with Denosumab in the past 6 months (5.) Active infection.
- •(6.) Known history of coronary artery disease (CAD), history of Stroke, a history of malignancy, other cardiac ailments active infection, pregnancy, and known alcohol or drug abuse at screening.
- •(7.) Patients currently on Teriparatide/ Bisphosphonates.
- •(8.) History of malignancy or parathyroidectomy.
- •(9.) Hypocalcemic (Ca less than 8.5 mg/dL), pregnant, lactating/nursing, at screening.
- •(10.) Physicians discretion.
结局指标
主要结局
Percentage change in BMD at lumbar spine and femur neck by dual x-ray absorptiometry (DEXA)
时间窗: from baseline to 6, 12 ,18 and 24 months
次要结局
- -Incidence of any fracture at 1 and 2 years.(- Changes in Fracture Risk Assessment Tool (FRAX) score)
研究者
Dr Jatin Kothari
Apex Kidney Care Pvt. Ltd.
研究点 (2)
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