Clinical trial NCT00423384: Ibandronate Versus Placebo in the Prevention of Bone Loss After Renal Transplantation.
Official title: Ibandronate Versus Placebo as add-on to Active Vitamin D and Calcium in the Prevention of Bone Loss After Renal Transplantation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Renal Transplant
Keywords: Ibandronate
Placebo
Doubleblind
Bone
loss
Kidney
transplant
Lead sponsor: Smerud Medical Research International AS
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2007-01-18
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in percent lumbar BMD change from baseline to 12 months between the two treatment groups.
timeFrame: December 2010
Secondary outcomes:
measure: Lumbar BMD change; absolute and relative
timeFrame: December 2010
measure: Hip BMD change; absolute and relative
timeFrame: December 2010
measure: Radial BMD change; absolute and relative
timeFrame: December 2010
measure: Femural BMD change; absolute and relative
timeFrame: December 2010
measure: Change in height
timeFrame: December 2010
measure: Change in biochemical efficacy and bone markers
timeFrame: December 2010
measure: Change in HRQoL scores (SF-36 and mini OQOL)
timeFrame: December 2010
measure: Incidence of post-transplant complications
timeFrame: December 2010
measure: Frequency of clinically significant safety laboratory variables
timeFrame: December 2010
measure: Adverse event rates
timeFrame: December 2010
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet-Radiumhospitalet Medical Center
Study officials:
affiliation: Smerud Medical Research International AS, Drammensveien 41, N-0271 Oslo, Norway
name: Knut T Smerud, MSc
role: STUDY_DIRECTOR
References: