Health Condition 1: Z940- Kidney transplant status
Conditions
Interventions
Intervention1: DENOSUMAB (60 MG - S/C INJECTION)- 2 DOSES 6 MONTHLY INTERVAL WITH CALCIUM CARBONATE (1GM/DAY) AND VIT D3 (1000 IU/DAY) FOR 12 MONTHS: DENOSUMAB (60 MG- S/C INJECTION) - 2 DOSES 6 MONTH
Sponsors
IPGMER AND SSKM HOSPITAL KOLKATA
Eligibility
Inclusion criteria
Inclusion criteria: 1. All the renal transplant recipients transplanted in our institute with less than 1 year from the date of renal transplant to study entry point. 2.Age older than 18 years. 3. DEXA SCAN T Score less than -2.5 i.e. suggestive of osteoporosis.
Exclusion criteria
Exclusion criteria: 1. eGFR 2. Patients after total parathyroidectomy and Evidence of severe hyper- or hypo-parathyroidism i.e.(iPTH >800 ng/l or 3. Patients treated with bisphosphonates, fluoride, calcitonin, or anabolic steroids with in 1 years of enrolment. 4. Hypocalcemia (total calcium 2.7 mmol/l or 10.8 mg/dl) (Patients will be included in the study after correcting the hypo or hypercalcemia.) 5. Active infections and/or malignancy. 6. Ongoing pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To see the changes in T Score in DEXA SCAN in both armsTimepoint: 6 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of Beta-CTX/ Beta-CrossLaps ( C-terminal telopeptide of type 1 collagen) and P1NP (Procollagen type 1 N ââ?¬â??terminal propeptide )Timepoint: 6 months and 12 months;Changes in serum Calcium, phosphorus, Parathyroid hormone level and 25(OH) VitaminD level.Timepoint: 6 months and 12 months;The factors involved in the changes in BMD.Timepoint: 6 months and 12 months;To capture any fracture event in the study population during 1 years of treatmentTimepoint: 6 months and 12 months;To see any adverse effectsTimepoint: 6 months and 12 months;To see the changes in FRAX SCORE( where applicable)Timepoint: 6 months and 12 months | — |
Countries
India
Contacts
Public ContactDR ATANU PAL
IPGMER AND SSKM HOSPITAL
Outcome results
None listed