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

University Hospital Center (CHU)

Status and phase

Terminated

Phase 4

Conditions

Female With Osteoporosis and Chronic Kidney Disease

Treatments

Drug: Denosumab

Drug: NaCl (placebo)

Study type

Interventional

Funder types

Other

Identifiers

RECHMPL15_0496

UF 9676 (Other Identifier)

Details and patient eligibility

About

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

Full description

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) (by bone densitometry) at 24 months
on bone mineral density evolution (femoral T-score) (by bone densitometry) after 24 months of follow-up
on bone mineral density evolution (lumbar T-score) (by bone densitometry) after 24 months of follow-up
on coronary and abdominal aorta calcification scores evolution (by multiple detector computed tomography and plain abdominal X-ray) 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

Enrollment

4 patients

Sex

Female

Ages

65 to 95 years old

Volunteers

No Healthy Volunteers

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)