Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: Not applicable: Not applicable
Control Intervention1: Not applicable: Not applicable
Sponsors
Dr Jatin Kothari
Dr Sanjeev Gulati Kidney Clinic
Eligibility
Inclusion criteria
Inclusion criteria: (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.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in BMD at lumbar spine and femur neck by dual x-ray absorptiometry (DEXA)Timepoint: from baseline to 6, 12 ,18 and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| -Incidence of any fracture at 1 and 2 years. - Changes in Fracture Risk Assessment Tool (FRAX) score -Changes in C- Terminal Polypeptide (CTX) from baseline to 6, 12,18 and 24 months -Improvement in health-related quality of life (HRQOL) by EQ-5D from baseline to 0,6,12,18 and 24 months -Incidence of adverse events and abnormal clinical findingsTimepoint: baseline to 6, 12 ,18 and 24 months. | — |
Countries
India
Contacts
Public ContactDr Jatin Kothari
Apex Kidney Care Pvt. Ltd.
Outcome results
None listed