TerminatedPhase 4

Study Evaluating Denosumab on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease

Stopped: Modified study and new deposit in RECHMPL21\_0451

France4 participantsStarted 2018-11-19

Plain-language summary

Aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease females the effect of denosumab: * on bone mineral density (femoral T-score) at 24 months * on bone mineral density evolution (femoral T-score) after 24 months of follow-up * on bone mineral density evolution (lumbar T-score) after 24 months of follow-up * on coronary and abdominal aorta calcification scores evolution after 24 months of follow-up * on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) after 24 months of follow-up * on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up * the tolerance after 24 months of follow-up

Who can participate

Age range65 Years – 95 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient of 65 years or older * Chronic kidney disease stage 5 patient, hemodialyzed with extracorporeal treatment for at least 3 months * Patient with osteoporosis (history of bone fracture or T-scoring \< -2.5 SD) * PTH levels in the serum in agreement with the KDIGO guidelines, in the absence of treatment with Cinacalcet. Exclusion Criteria: * Cinacalcet treatment * Calcium parameters (PTH, 25(OH) vitamin D3, Calcium) outside the KDIGO guidelines * Suspicion of lower bone remodeling * Hypersensibility to active substance or one of excipients of denosumab * Patient with a cancer or myeloma * Patient with severe heaptic cytolysis * Patients with severe teeth problems * Patient positive for HIV * Patient involved in another biomedical research * Vulnerable patients (protected by the law, under guardianship, deprived of freedom)

What they're measuring

Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)

Timeframe: 24 months after inclusion

Trial details

NCT IDNCT02792413

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-10