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Ibandronate Versus Placebo in the Prevention of Bone Loss After Renal Transplantation.

NCT00423384 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2010-03-24

No results posted yet for this study

Summary

Loss of bone mass is a common complication in patients with end-stage-renal failure, both before and particularly after transplantation. In addition to standard underlying therapy with calcium and active vitamin D, we will study the effect of ibandronate (a bisphosphonate) versus placebo on bone mineral density as well as incidence of fracture rates after kidney transplantation.We also wish to study whether any prevented bone loss will also lead to reduced cardiovascular disease. Patients will be followed for 12 months after transplantation, and the ibandronate treatment is one injection every 3 months.

Conditions

  • Renal Transplant

Interventions

DRUG

Placebo

Placebo

DRUG

Ibandronate

I.v.

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • Smerud Medical Research International AS

    lead OTHER

Principal Investigators

  • Knut T Smerud, MSc · Smerud Medical Research International AS, Drammensveien 41, N-0271 Oslo, Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-12-31
Completion
2010-12-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs

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 NCT00423384 on ClinicalTrials.gov