To compare the effect of injection Denosumab in chronic kidney disease patients over tablet calcium and vitamin D supplementation in decreasing the risk of fracture
- Conditions
- Health Condition 1: N189- Chronic kidney disease, unspecified
- Registration Number
- CTRI/2023/11/059536
- Lead Sponsor
- Institute of Post Graduate Medical Education and Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.All the CKD patients in stage 3 to 5 visiting nephrology OPD of our institute or admitted in the department of Nephrology.
2.Age older than 18 years.
3.DEXA scan T score less than -2.5 (suggestive of osteoporosis) and/or FRAX score of >20% of major osteoporotic fracture and >3% for hip fracture.
1.Patients with ongoing dialysis.
2. Patients after total parathyroidectomy and evidence of severe hyper- or hypoparathyroidism (iPTH >800 or <10 ng/l)
3.Patients treated with bisphosphonates, fluoride, calcitonin, or anabolic steroids within 1 year of enrolment.
4. Hypocalcemia (total calcium <1.8 mmol/l or 7.2 mg/dl) or hypercalcemia(total calcium >2.7 mmol/l or 10.8 mg/dl)
(patiennts will be included in the study after correction of hypo or hypercalcemia)
5.Patients who are already received Denosummab, Teriparatide, SERM,Hormone replacement therapy, Romosuzumab.
6. Active infections and/or malignancy.
7.Ongoing pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absolute and percentage change in T score in DEXA SCAN from baseline at 12 months after therapy.Timepoint: baseline, 12 months
- Secondary Outcome Measures
Name Time Method 1.change in BMD from baseline at 12 months after therapy. <br/ ><br>2.Change in serum Beta CTX and P1NP from baseline at 12 months after therapy. <br/ ><br>3.Incidence of any clinically evident osteoporotic fracture during 12 months follow up period. <br/ ><br>4.Any progression of CKD stage according to KDIGO guidelines to be calculated by eCFR by CKD EPI from baseline to 12 months after therapy.Timepoint: Baseline, 12 months