Denosumab Treatment in CKD Patients at High Risk of Fracture

Chronic Kidney Diseases Clinical Trial

Official title:

Denosumab Treatment in Patients With Chronic Kidney Disease (CKD) at High Risk of Fracture: A Prospective, Randomised Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05692297
• Other study ID #: K2022-203-00
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2023
• Source: Capital Medical University
• Contact: Dongliang Zhang, Director
• Phone: +861058396938
• Email: zdlycy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: To verify the efficacy and safety of denosumab in the prevention and treatment of CKD-MBD in CKD patients with high risk of fracture.

Methods: A cohort of CKD patients with high risk of fracture was established and followed up for long periods (≥24 months). Patients with CKD3b-5D stage and fracture risk assessment tool (FRAX) scores at high risk or very high risk of fracture were enrolled. A multicenter, prospective, open-label, randomised controlled, interventional study was conducted. The patients were divided into two groups. The patients in the denosumab group received subcutaneous injection of denosumab 60mg once every 6 months, and the patients in the non-denosumab group received conventional treatment. Bone metabolic markers (serum calcium, phosphorus, vitamin D, parathyroid hormone, alkaline phosphatase, tartrate-resistant acid phosphatase 5b, osteocalcin, total N-terminal propeptide of type I collagen, etc.), bone mineral density (dual-energy X-ray, quantitative CT), and vascular calcification score were regularly monitored. All adverse events (all-cause death, cardiovascular death, cardiac events, fracture, hospitalization, emergency department visits, etc.) were recorded during the follow-up period. Bone mineral density and clinical parameters were compared between the two groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Density, Low
• Bone Diseases, Metabolic
• Chronic Kidney Diseases
• End Stage Renal Disease
• Fracture
• Fractures, Bone
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Drug:
• Denosumab
The patients in the denosumab group received subcutaneous injection of denosumab 60mg once every 6 months for 24 months.
• Non-denosumab
Taken other medications, such as diphosphonates, active vitamin D and/or active vitamin D analogue, calcimimetics, calcitonin, estrogen receptor agonists, etc.

Locations

Country	Name	City	State
China	Nephrology Department of Beijing Jishuitan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of bone mineral density (BMD) decline at the lumbar spine	Rate of BMD decline =[(BMD24-BMD Baseline)÷BMD baseline]*100%	24 months
Secondary	Rate of fresh fractures, cardiovascular cerebrovascular adverse events and all-cause mortality	Fresh fractures were new non-traumatic fractures during follow-up. Cardiovascular cerebrovascular adverse events were Acute myocardial infarction, heart failure, shock, cardiac arrest, stroke, and lower limb arterial occlusion occurred during follow-up. All-cause mortality was death from any cause during follow-up.	24 months