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

Renal Transplant Clinical Trial

Official title:

Ibandronate Versus Placebo as add-on to Active Vitamin D and Calcium in the Prevention of Bone Loss After Renal Transplantation.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00423384
• Other study ID #: SMR-1471
• Secondary ID: EUDRACT no.: 200
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: January 17, 2007
• Last updated: March 22, 2010
• Start date: January 2007
• Est. completion date: December 2010

Study information

• Verified date: March 2010
• Source: Smerud Medical Research International AS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Transplant

Intervention

Drug:
• Placebo
Placebo
• Ibandronate
I.v.

Locations

Country	Name	City	State
Norway	Rikshospitalet-Radiumhospitalet Medical Center	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Smerud Medical Research International AS	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in percent lumbar BMD change from baseline to 12 months between the two treatment groups.		December 2010	No
Secondary	Lumbar BMD change; absolute and relative		December 2010	No
Secondary	Hip BMD change; absolute and relative		December 2010	No
Secondary	Radial BMD change; absolute and relative		December 2010	No
Secondary	Femural BMD change; absolute and relative		December 2010	No
Secondary	Change in height		December 2010	No
Secondary	Change in biochemical efficacy and bone markers		December 2010	No
Secondary	Change in HRQoL scores (SF-36 and mini OQOL)		December 2010	No
Secondary	Incidence of post-transplant complications		December 2010	Yes
Secondary	Frequency of clinically significant safety laboratory variables		December 2010	Yes
Secondary	Adverse event rates		December 2010	Yes