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Efficacy and safety evaluation of denosumab in maintenance hemodialysis patients witn osteoporosis:a randomized controlled, multicenter, optimal efficacy study

Efficacy and safety evaluation of denosumab in maintenance hemodialysis patients witn osteoporosis:a randomized controlled, multicenter, optimal efficacy study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088032
Enrollment
Unknown
Registered
2024-08-09
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

maintenance hemodialysis patients witn osteoporosis

Interventions

denosumab combined with conventional treatment group:denosumab injection 60mg, injected subcutaneously every six months
conventional treatment group:coutinue with the original therapeutic schedule

Sponsors

The Third Affiliated Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1)Voluntarily sign informed consent.2) Age 18-80.3) Regular maintenance hemodialysis for at least 3 months with any of the following three criteria: hip or vertebral fragility fracture; Bone mineral density of axial bone or bone mineral density of distal 1/3 of radius was evaluated by dual-energy X-ray densitometry (DXA) with T value=-2.5; Bone density measurements were consistent with reduced bone mass and a brittle fracture of the proximal humerus, pelvis, or distal forearm.

Exclusion criteria

Exclusion criteria: 1) Those who have contraindicated the use of denosumab. 2) Patients who have used anti-osteoporosis drugs such as bisphosphonates and denosumab in the past 6 months. 3)iPTH< 150pg/ml. 4) Corrected calcium<8.4mg/dL. 5) Patients with cancer, severe liver insufficiency, serious heart disease including coronary heart disease, heart failure,and arrhythmia. 6) Fertile women who are not on contraception, pregnant or breastfeeding. 7) Any medical or surgical conditions not specified in the protocol that the investigator believes may pose a high risk to the patient or prevent the patient from complying with the study requirements or completing the study.

Design outcomes

Primary

MeasureTime frame
fracture;

Secondary

MeasureTime frame
Vascular calcification and incidence of cardiovascular events;

Countries

China

Contacts

Public ContactTANG YING

The Third Affiliated Hospital of Southern Medical University

ty.102@163.com+86 135 3364 6831

Outcome results

None listed

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