The Effects Of Denosumab On Bone health in renal Allograft Transplant Patients.
Not Applicable
- Conditions
- Health Condition 1: N186- End stage renal disease
- Registration Number
- CTRI/2021/11/038018
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
•All patients 18 years and above undergoing renal allograft transplant in the Department of Renal Transplant Surgery, PGIMER Chandigarh.
Exclusion Criteria
•Allograft dysfunction: Serum creatinine value above 2.5mg/dl at three weeks post transplantation.
•Patient with severe hyperparathyroidism or hypoparathyroidism (iPTH >800 or <10ng/L) prior to transplant.
•Patients with severe hypocalcaemia or hypercalcemia (total calcium <7.2 or > 11mg/dl) prior to transplant.
•If subject failed to lay supine position during DEXA scan.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method oTo assess the changes in bone mineral density of lumbar spine and hip in a time dependant manner serially at 6 months and 12 months after renal transplantation in patients receiving and not receiving denosumab. <br/ ><br>oTo compare the changes in bone turnover post renal transplantation serially at and 12 months in patients who receive and do not receive denosumab. <br/ ><br>Timepoint: oTo assess the changes in bone mineral density of lumbar spine and hip in a time dependant manner serially at 6 months and 12 months after renal transplantation in patients receiving and not receiving denosumab. <br/ ><br>oTo compare the changes in bone turnover post renal transplantation serially at and 12 months in patients who receive and do not receive denosumab. <br/ ><br>
- Secondary Outcome Measures
Name Time Method oTo assess and compare changes in bone histomorphometry on bone biopsy at zero hour and at 12 months post-transplant in patients who receive and do not receive denosumab. <br/ ><br>oTo compare the risk of renal allograft rejection between these two groups. <br/ ><br> <br/ ><br>Timepoint: 1 year 3 months