This trial is active, not recruiting.

Condition renal transplant
Treatments placebo, ibandronate
Phase phase 2/phase 3
Sponsor Smerud Medical Research International AS
Collaborator Oslo University Hospital
Start date January 2007
End date December 2009
Trial size 130 participants
Trial identifier NCT00423384, EUDRACT no.: 2006-003884-30, SMR-1471


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Placebo Comparator)

Primary Outcomes

Difference in percent lumbar BMD change from baseline to 12 months between the two treatment groups.
time frame: December 2010

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Renal transplant recipients - Adults, ≥ 18 years of age - Either gender - Signed informed consent Exclusion Criteria: - Persisting s-Ca > 2.55 mmol/L (through the first two weeks after transplantation) - Impaired graft functioning (estimated GFR <30 ml/min) - Previous (within the last 12 months) treatment with bisphosphonates, sodium fluoride, calcitonin, strontium, PTH, SERM, growth hormone or anabolic steroids at any time before transplantation. - Known adynamic bone disease - Previous parathyroidectomy - Pregnant or lactating females or females of childbearing potential who do not use an approved method of contraception (oral contraceptives or IUD); positive urine pregnancy test, where applicable. - Use of any investigational drug (s) and/or device(s) - Previous participation in this trial - History of hypersensitivity to bisphosphonates

Additional Information

Official title Ibandronate Versus Placebo as add-on to Active Vitamin D and Calcium in the Prevention of Bone Loss After Renal Transplantation.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by Smerud Medical Research International AS.