EUCTR2016-000431-40-FR
Active, not recruiting
Phase 1
Randomized controlled study evaluating the effect of a biotherapy treatment (anti-RANKL ligand antibody: Denosumab) on bone and vascular metabolism in osteoporotic chronic kidney disease - HDENO
Health Ministry0 sitesJune 17, 2016
ConditionsMedDRA version: 19.0Level: LLTClassification code 10009119Term: Chronic renal failureSystem Organ Class: 100000004857Therapeutic area: Not possible to specify
DrugsProlia
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- MedDRA version: 19.0Level: LLTClassification code 10009119Term: Chronic renal failureSystem Organ Class: 100000004857
- Sponsor
- Health Ministry
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient female of 65 years or older
- •Chronic kidney disease stage 5 patient, hemodialyzed with extracorporeal treatment for at least 3 months
- •History of vertebral fracture
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range 0
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 30
Exclusion Criteria
- •Cinacalcet treatment
- •Substitutive hormonal treatment
- •Calcium phosphate balance (PTH, 25(OH) vitamin D3, Calcium, phosphate) outside the KDIGO guidelines
- •Hypersensibility to active substance or one of excipients of Prolia®
Outcomes
Primary Outcomes
Not specified
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