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

NCT02792413 | Terminated Phase 4 DMC

• 2 other identifiers: RECHMPL15_0496UF 9676
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 9

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

Conditions

Female With Osteoporosis and Chronic Kidney Disease

Keywords

osteoporosis; chronic kidney disease; anti-RANK ligand antibody; bone mineral density; vascular calcifications

Outcome Measures

Primary Outcomes (1)

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

  24 months after inclusion

Secondary Outcomes (7)

• 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

• 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

• Variation of phosphorus at 6, 12, 18 et 24 months of follow-up

  6, 12, 18 and 24 months after inclusion

Study Arms (2)

Denosumab

EXPERIMENTAL

Denosumab 60 mg, subcutaneous injection every 6 months for 24 months

Drug: Denosumab

Placebo

PLACEBO COMPARATOR

NaCl 0.9% (1 mL), subcutaneous injection every 6 months for 24 months

Drug: NaCl (placebo)

Interventions

Denosumab DRUG

Patients will receive a subcutaneous injection of Denosumab every 6 months for the duration of the study. In addition, they will receive vitamin D and calcium (which is the normal treatment) for the duration of the study.

Denosumab

NaCl (placebo) DRUG

Patients will receive a subcutaneous injection of NaCl every 6 months for the duration of the study. In addition, they will receive vitamin D and calcium (which is the normal treatment) for the duration of the study.

Placebo

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (9)

Clinique Médipole Cabestany

Cabestany, France

Location

CHL Castelnau Le Lez

Castelnau-le-Lez, France

Location

CHU Lyon Sud, Nephrology department

Lyon, France

Location

AP-HM, Nephrology department

Marseille, France

Location

AIDER

Montpellier, France

Location

CHU Montpellier, Nephrology department

Montpellier, France

Location

CHU Nice, Nephrology department

Nice, France

Location

CHU Nimes, Nephrology department

Nîmes, France

Location

CH Perpignan, Nephrology department

Perpignan, France

Location

Related Publications (1)

• Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013424. doi: 10.1002/14651858.CD013424.pub2.

  PMID: 34231877 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Osteoporosis; Vascular Calcification

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcinosis; Calcium Metabolism Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jean-Paul CRISTOL, Prof

  CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 7, 2016
• Study Start: November 19, 2018
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: August 9, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)