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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Oslo University Hospital
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Renal Transplant Drug: Placebo Drug: Ibandronate Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: Ibandronate

Placebo Comparator: 2 Drug: Placebo

Primary Outcome Measures :
  1. Difference in percent lumbar BMD change from baseline to 12 months between the two treatment groups. [ Time Frame: December 2010 ]

Secondary Outcome Measures :
  1. Lumbar BMD change; absolute and relative [ Time Frame: December 2010 ]
  2. Hip BMD change; absolute and relative [ Time Frame: December 2010 ]
  3. Radial BMD change; absolute and relative [ Time Frame: December 2010 ]
  4. Femural BMD change; absolute and relative [ Time Frame: December 2010 ]
  5. Change in height [ Time Frame: December 2010 ]
  6. Change in biochemical efficacy and bone markers [ Time Frame: December 2010 ]
  7. Change in HRQoL scores (SF-36 and mini OQOL) [ Time Frame: December 2010 ]
  8. Incidence of post-transplant complications [ Time Frame: December 2010 ]
  9. Frequency of clinically significant safety laboratory variables [ Time Frame: December 2010 ]
  10. Adverse event rates [ Time Frame: December 2010 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00423384

Rikshospitalet-Radiumhospitalet Medical Center
Oslo, Norway, 0027
Sponsors and Collaborators
Smerud Medical Research International AS
Oslo University Hospital
Study Director: Knut T Smerud, MSc Smerud Medical Research International AS, Drammensveien 41, N-0271 Oslo, Norway

Responsible Party: Knut Smerud, Smerud Medical Research International AS Identifier: NCT00423384     History of Changes
Other Study ID Numbers: SMR-1471
EUDRACT no.: 2006-003884-30
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: March 24, 2010
Last Verified: March 2010

Keywords provided by Smerud Medical Research International AS:

Additional relevant MeSH terms:
Ibandronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs