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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-19

Study Completion Date

2020-12-10

Brief Summary

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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

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Detailed Description

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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

Conditions

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Female With Osteoporosis and Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Denosumab

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

Group Type EXPERIMENTAL

Denosumab

Intervention Type 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.

Placebo

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

Group Type PLACEBO_COMPARATOR

NaCl (placebo)

Intervention Type 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.

Interventions

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Denosumab

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.

Intervention Type DRUG

NaCl (placebo)

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.

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

65 Years

Maximum Eligible Age

95 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No