CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 90 enrolled
Drug / intervention
Denosumab (Prolia)drug
Likely dose
Denosumab (Prolia) 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01377467
NCT01377467Phase 3Completed
CompareCT.gov

A Phase 3, Investigator-initiated, Randomized, Open-label Single-center Study of the Effect of Denosumab on the Prevention of Bone Mineral Density Loss After Renal Transplantation

Rudolf Wuethrich·interventional·Posted Jun 21, 2011·Updated May 26, 2016

In Brief

A Phase 3 clinical trial evaluating Denosumab (Prolia) for Osteoporosis and Chronic Kidney Disease. Completed, enrolled 90 participants across 1 site.

Detailed Summary

The primary objective of the study is to examine the effect of denosumab on lumbar spine bone mineral density (BMD) after one year of treatment in newly transplanted renal allograft recipients. Secondary endpoints include BMD changes at the total hip and the femoral neck, changes in body height, changes in bone mineral metabolism parameters, incidence of fractures, and allograft function at one year. Safety measurements include the occurrence of rejection episodes, infectious complications, graft loss and mortality. * Trial with medicinal product

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis, Chronic Kidney Disease
CountriesSwitzerland
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 21, 2011
Enrollment StartJun 1, 2011
Primary CompletionMay 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 15.0 years ago

Interventions

Denosumab (Prolia)drug

60 mg s.c. injection at baseline and after 6 months