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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Smerud Medical Research International AS.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by:
Smerud Medical Research International AS
ClinicalTrials.gov Identifier:
NCT00423384
First received: January 17, 2007
Last updated: March 22, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
Renal Transplant
Drug: Placebo
Drug: Ibandronate
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Smerud Medical Research International AS:

Primary Outcome Measures:
  • Difference in percent lumbar BMD change from baseline to 12 months between the two treatment groups. [ Time Frame: December 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lumbar BMD change; absolute and relative [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
  • Hip BMD change; absolute and relative [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
  • Radial BMD change; absolute and relative [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
  • Femural BMD change; absolute and relative [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
  • Change in height [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
  • Change in biochemical efficacy and bone markers [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
  • Change in HRQoL scores (SF-36 and mini OQOL) [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
  • Incidence of post-transplant complications [ Time Frame: December 2010 ] [ Designated as safety issue: Yes ]
  • Frequency of clinically significant safety laboratory variables [ Time Frame: December 2010 ] [ Designated as safety issue: Yes ]
  • Adverse event rates [ Time Frame: December 2010 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 130
Study Start Date: January 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ibandronate
Drug: Ibandronate
I.v.
Placebo Comparator: 2 Drug: Placebo
Placebo

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423384

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

No publications provided

Responsible Party: Knut Smerud, Smerud Medical Research International AS
ClinicalTrials.gov Identifier: NCT00423384     History of Changes
Other Study ID Numbers: SMR-1471, EUDRACT no.: 2006-003884-30
Study First Received: January 17, 2007
Last Updated: March 22, 2010
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Smerud Medical Research International AS:
Ibandronate
Placebo
Doubleblind
Bone
loss
Kidney
transplant

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

ClinicalTrials.gov processed this record on September 22, 2014