This is a type of 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.
- Conditions
- Health Condition 1: N189- Chronic kidney disease, unspecified
- Registration Number
- CTRI/2024/03/064791
- Lead Sponsor
- Dr Jatin Kothari
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
(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.
(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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method