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

Fracture risk reduction with denosumab in chronic kidney disease stage 3-5 - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059536

Enrollment

104

Registered

2023-11-06

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N189- Chronic kidney disease, unspecified

Interventions

Intervention1: Inj Denosumab: Inj Denosumab 60 mcg to be given 6 monthly subcutaneous along with calcium 1000 mg daily and vitamin D3 1000 IU daily Control Intervention1: Placebo: Placebo is 1 ml norm

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 1.Patients with ongoing dialysis. 2. Patients after total parathyroidectomy and evidence of severe hyper- or hypoparathyroidism (iPTH >800 or 3.Patients treated with bisphosphonates, fluoride, calcitonin, or anabolic steroids within 1 year of enrolment. 4. Hypocalcemia (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.

Design outcomes

Primary

Measure	Time frame
Absolute and percentage change in T score in DEXA SCAN from baseline at 12 months after therapy.Timepoint: baseline, 12 months	—

Secondary

Measure	Time frame
1.change in BMD from baseline at 12 months after therapy. 2.Change in serum Beta CTX and P1NP from baseline at 12 months after therapy. 3.Incidence of any clinically evident osteoporotic fracture during 12 months follow up period. 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	—

Countries

India

Contacts

Public ContactLaky Saha

Institute of Post Graduate Medical Education and Research

drsgupta007@gmail.com9830082267

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026