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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000431-40-FR

Enrollment

Registered

2016-06-17

Start date

2016-05-19

Completion date

Unknown

Last updated

2025-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 19.0 Level: LLT Classification code 10009119 Term: Chronic renal failure System Organ Class: 100000004857

Interventions

Trade Name: Prolia Product Name: denosumab Product Code: 55513-710 Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the

Eligibility

Sex/Gender

All

Inclusion 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

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®

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of denosumab on bone mineral density (femoral T-score) at 24 months in a population of old osteoporotic chronic kidney disease females;Secondary Objective: To evaluate the effect of denosumab on bone mineral density evolution (femoral T-score) after 24 months of follow-up To evaluate the effect of denosumab on bone mineral density evolution (lumbar T-score) after 24 months of follow-up To evaluate the effect of denosumab on coronary and abdominal aorta calcification scores evolution after 24 months of follow-up To evaluate the effect of denosumab 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 To evaluate the effect of denosumab on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up To evaluate the tolerance after 24 months of follow-up;Primary end point(s): Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry);Timepoint(s) of evaluation of this end point: month 0, month 24	—

Measure

Time frame

Main Objective: To evaluate the effect of denosumab on bone mineral density (femoral T-score) at 24 months in a population of old osteoporotic chronic kidney disease females;Secondary Objective: To evaluate the effect of denosumab on bone mineral density evolution (femoral T-score) after 24 months of follow-up To evaluate the effect of denosumab on bone mineral density evolution (lumbar T-score) after 24 months of follow-up To evaluate the effect of denosumab on coronary and abdominal aorta calcification scores evolution after 24 months of follow-up To evaluate the effect of denosumab 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 To evaluate the effect of denosumab on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up To evaluate the tolerance after 24 months of follow-up;Primary end point(s): Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry);Timepoint(s) of evaluation of this end point: month 0, month 24

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Secondary

Measure	Time frame
Secondary end point(s): - Relative variation of femoral bone mineral density after 12 months of follow-up and evolution during the 24 months of follow-up - Relative variation of lumbar bone mineral density after 12 and 24 months of follow-up and evolution during the 24 months of follow-up - Evolution of coronary calcification scores at 12 and 24 months of follow-up - Evolution of abdominal aorta calcification scores at 12 and 24 months of follow-up - Variation of parameters of bone remodelling, calcium phosphorus metabolism and inflammation at 6, 12, 18 et 24 months of follow-up - Morbi-mortality at 24 months of follow-up - Adverse events occuring during the entire study;Timepoint(s) of evaluation of this end point: month 0, 6, 12, 18, 24	—

Measure

Time frame

Secondary end point(s): - Relative variation of femoral bone mineral density after 12 months of follow-up and evolution during the 24 months of follow-up - Relative variation of lumbar bone mineral density after 12 and 24 months of follow-up and evolution during the 24 months of follow-up - Evolution of coronary calcification scores at 12 and 24 months of follow-up - Evolution of abdominal aorta calcification scores at 12 and 24 months of follow-up - Variation of parameters of bone remodelling, calcium phosphorus metabolism and inflammation at 6, 12, 18 et 24 months of follow-up - Morbi-mortality at 24 months of follow-up - Adverse events occuring during the entire study;Timepoint(s) of evaluation of this end point: month 0, 6, 12, 18, 24

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Countries

France

Contacts

Public ContactClinical trial information

CHU Montpellier

a-fraysse@chu-montpellier.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026