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Denosumab for Prevention of Osteoporosis in Renal Transplant Recipients

NCT01377467 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2016-05-26

Study results available
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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

Conditions

Interventions

DRUG

Denosumab (Prolia)

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

Sponsors & Collaborators

  • Rudolf Wuethrich

    lead OTHER

Principal Investigators

  • Rudolf P Wuthrich, MD · Division of Nephrology, University Hospital, Zurich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2015-05-31
Completion
2015-10-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01377467 on ClinicalTrials.gov