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

Phase 4

Terminated

• Conditions: Female With Osteoporosis and Chronic Kidney Disease
• Interventions: Drug: NaCl (placebo); Drug: Denosumab

• Registration Number: NCT02792413
• Lead Sponsor: University Hospital, Montpellier

Brief 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

Detailed 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

Study Timeline

• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-06
• Study First Posted: 2016-06-07
• Study Start: 2018-11-19
• Primary Completion: 2020-12-10
• Study Completion: 2020-12-10
• Status Verified: 2022-04
• Last Update Submitted: 2023-08-08
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	NaCl (placebo)	NaCl 0.9% (1 mL), subcutaneous injection every 6 months for 24 months
Denosumab	Denosumab	Denosumab 60 mg, subcutaneous injection every 6 months for 24 months

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Morbi-mortality at 24 months of follow-up	24 months after inclusion
Variation of phosphorus at 6, 12, 18 et 24 months of follow-up	6, 12, 18 and 24 months after inclusion
Relative variation of abdominal aorta calcification scores after 24 months of follow-up	24 months after inclusion
Variation of calcium at 6, 12, 18 and 24 months of follow-up	6, 12, 18 and 24 months after inclusion
Relative variation of lumbar bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)	24 months after inclusion
Relative variation of coronary calcification scores after 24 months of follow-up	24 months after inclusion
Adverse events occuring during the entire study	24 months after inclusion

Trial Locations

Locations (9)

CHU Lyon Sud, Nephrology department; 🇫🇷 Lyon, France

AIDER; 🇫🇷 Montpellier, France

Clinique Médipole Cabestany; 🇫🇷 Cabestany, France

CHL Castelnau Le Lez; 🇫🇷 Castelnau-le-Lez, France

CHU Montpellier, Nephrology department; 🇫🇷 Montpellier, France

CHU Nice, Nephrology department; 🇫🇷 Nice, France

AP-HM, Nephrology department; 🇫🇷 Marseille, France

CHU Nimes, Nephrology department; 🇫🇷 Nimes, France

CH Perpignan, Nephrology department; 🇫🇷 Perpignan, France