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Efficacy and safety of desomumab in the treatment of chronic kidney disease-mineral and bone disorder complicated with low bone mineral density

The role and mechanism of PTH-OPG/RANKL in chronic kidney disease-mineral and bone disorder complicated with low bone mineral density

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056463
Enrollment
Unknown
Registered
2022-02-06
Start date
2022-04-01
Completion date
Unknown
Last updated
2024-10-15

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

Conditions

chronic kidney disease-mineral and bone disorder

Interventions

test group:Denosumab 60mg subcutaneously

Sponsors

Tianjin Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The diagnosis of CKD-MBD with low bone mineral density is clear; 2. Males, aged 60 years and over; 3. Calcium, phosphorus, PTH metabolism is stable or the following standards are met after treatment: Calcium 2.2 - 2.6mmol/L, Phosphorus 0.87 - 1.45mmol/L, PTH 150 - 300pg/ml; 4. Complete clinical data; 5. Patient informed consent.

Exclusion criteria

Exclusion criteria: 1. Long-term bed rest; 2. Confirmed Cushing's syndrome, hypogonadism, hyperthyroidism, primary hyperparathyroidism, plasma cell disease, leukemia and lymphoma, myelodysplastic syndrome, systemic lupus erythematosus, rheumatoid arthritis, Osteogenesis imperfecta, primary and metastatic bone tumors and other primary diseases that may lead to secondary osteoporosis; 3. Long-term use of glucocorticoids, anticonvulsants, methotrexate, cyclosporine, thyroid hormones, aluminum-containing antacids, etc.; 4. In the past 3 months, the use of estrogen, calcitonin, bisphosphonates, teriparatide, Xianling Gubao and other drugs affecting bone metabolism; 5. It is contraindicated in drug application such as history of allergy to denosumab and hypocalcemia.

Design outcomes

Primary

MeasureTime frame
Ca;P;BAP;PINP;ß-CTX;bone mineral density;

Countries

China

Contacts

Public ContactYang Dingwei

Tianjin Hospital

dxyang0072003@163.com+86 13512052807

Outcome results

None listed

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