Status:
UNKNOWN
Ibandronate Versus Placebo in the Prevention of Bone Loss After Renal Transplantation.
Lead Sponsor:
Smerud Medical Research International AS
Collaborating Sponsors:
Oslo University Hospital
Conditions:
Renal Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 act...
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 score...
Eligibility Criteria
Inclusion
- Renal transplant recipients
- Adults, ≥ 18 years of age
- Either gender
- Signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00423384
Start Date
January 1 2007
End Date
December 1 2010
Last Update
March 24 2010
Active Locations (1)
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1
Rikshospitalet-Radiumhospitalet Medical Center
Oslo, Norway, 0027