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

Phase 2

• Conditions: Renal Transplant
• Interventions: Drug: Placebo; Drug: Ibandronate

• Registration Number: NCT00423384
• Lead Sponsor: Smerud Medical Research International AS

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-17
• Study First Submitted QC: 2007-01-17
• Study First Posted: 2007-01-18
• Primary Completion: 2009-12
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-22
• Last Update Posted: 2010-03-24
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Renal transplant recipients
• Adults, ≥ 18 years of age
• Either gender
• Signed informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Ibandronate	Ibandronate

Primary Outcome Measures

Name	Time	Method
Difference in percent lumbar BMD change from baseline to 12 months between the two treatment groups.	December 2010

Secondary Outcome Measures

Name	Time	Method
Lumbar BMD change; absolute and relative	December 2010
Hip BMD change; absolute and relative	December 2010
Radial BMD change; absolute and relative	December 2010
Femural BMD change; absolute and relative	December 2010
Change in height	December 2010
Change in biochemical efficacy and bone markers	December 2010
Change in HRQoL scores (SF-36 and mini OQOL)	December 2010
Incidence of post-transplant complications	December 2010
Frequency of clinically significant safety laboratory variables	December 2010
Adverse event rates	December 2010

Trial Locations

Locations (1)

Rikshospitalet-Radiumhospitalet Medical Center; 🇳🇴 Oslo, Norway