Denosumab Treatment in CKD Patients at High Risk of Fracture
Chronic Kidney Diseases, Fracture, Bone Density, Low
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Denosumab, Chronic Kidney Diseases, Treatment, Fracture
Eligibility Criteria
Inclusion Criteria: ≥18 years old; Stage 3b-5D chronic kidney disease; The 10-year probability of hip fracture assessed by fracture risk assessment tool (FRAX) was >5%; Voluntarily signed informed consent. Exclusion Criteria: Age < 18 or ≥100 years; Premenopausal women; Denosumab was absolutely contraindicated; Had received denosumab or bisphosphonates therapy; Tertiary hyperparathyroidism; Patients with malignant tumor; Patients at risk for osteonecrosis of the jaw; Estimated follow-up time ≤12 months.
Sites / Locations
- Nephrology Department of Beijing Jishuitan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Denosumab group
Non-denosumab group
Fifty-one patients were randomly assigned to the denosumab group, which received subcutaneous injection of denosumab 60mg once every 6 months. Serum calcium, phosphorus, alkaline phosphatase, iPTH, tPINP, 25(OH)VitD, DXA and qCT were measured before medication. Serum calcium, phosphorus and iPTH were examined at day 1, 7 and 14, alkaline phosphatase, tPINP and 25(OH)VitD at day 7 and 14, and electrocardiogram at day 1 and 7 after treatment. Intravenous calcium supplementation was required if muscle spasms and QT prolongation occurred. Six months after medication, subcutaneous injections of denosumab 60mg were repeated. The protocol was repeated every 6 months, totally 24 months. Bone mineral density, clinical parameters and adverse events were evaluated at 24 months.
The other 51 patients did not use denosumab and used other medications, such as diphosphonates, active vitamin D and/or active vitamin D analogue, calcimimetics, calcitonin, estrogen receptor agonists, etc. At the same time, calcium and vitamin D were supplemented. The baseline serum calcium, phosphorus, alkaline phosphatase, iPTH, tPINP, 25(OH)VitD, DXA, and qCT were measured. The above parameters were rechecked every 6 months, and the medications was recorded, totally 24 months.