Ibandronate Versus Placebo in the Prevention of Bone Loss After Renal Transplantation.
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|ClinicalTrials.gov Identifier: NCT00423384|
Recruitment Status : Unknown
Verified March 2010 by Smerud Medical Research International AS.
Recruitment status was: Active, not recruiting
First Posted : January 18, 2007
Last Update Posted : March 24, 2010
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplant||Drug: Placebo Drug: Ibandronate||Phase 2 Phase 3|
Demographic, medical history, previous and current medication, as well as baseline measurements of Bone Mineral Density (BMD), laboratory efficacy and safety variables as well as Quality-of-Life scores will be undertaken in the period from 1 week prior to transplantation until 1 week after transplantation. In this period, any existing fractures will be determined using traditional x-ray of the thoraco-lumbar columna. Renal graft functioning as well as transplantation complications will be followed tightly, and calcium supplementation as well as active vitamin D (calcitriol) will be administered together with the standard immunosuppressive regimen.
As soon as patients have recovered from transplantation, and renal functioning is considered sufficiently stable, and no later than 28 days after the transplantation, qualified patients will be randomised to receive either ibandronate or placebo, stratified by gender. Bone mineral density and most of the clinical data and laboratory tests will then be followed until 12 months after transplantation as described in the attached flowchart (section 11.1), with hospital visits for administration of study drugs and follow-up of at 13, 26, 39 and 52 weeks after transplantation. Furthermore, all the patients will be followed prospectively from the time of transplantation and for ten years with regard to cardiovascular events. Data concerning cardiovascular events will be collected from the Norwegian renal registry for the whole study population in the follow up period of about 10 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Ibandronate Versus Placebo as add-on to Active Vitamin D and Calcium in the Prevention of Bone Loss After Renal Transplantation.|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||December 2010|
|Placebo Comparator: 2||
- Difference in percent lumbar BMD change from baseline to 12 months between the two treatment groups. [ Time Frame: December 2010 ]
- Lumbar BMD change; absolute and relative [ Time Frame: December 2010 ]
- Hip BMD change; absolute and relative [ Time Frame: December 2010 ]
- Radial BMD change; absolute and relative [ Time Frame: December 2010 ]
- Femural BMD change; absolute and relative [ Time Frame: December 2010 ]
- Change in height [ Time Frame: December 2010 ]
- Change in biochemical efficacy and bone markers [ Time Frame: December 2010 ]
- Change in HRQoL scores (SF-36 and mini OQOL) [ Time Frame: December 2010 ]
- Incidence of post-transplant complications [ Time Frame: December 2010 ]
- Frequency of clinically significant safety laboratory variables [ Time Frame: December 2010 ]
- Adverse event rates [ Time Frame: December 2010 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00423384
|Rikshospitalet-Radiumhospitalet Medical Center|
|Oslo, Norway, 0027|
|Study Director:||Knut T Smerud, MSc||Smerud Medical Research International AS, Drammensveien 41, N-0271 Oslo, Norway|