A 1-Year Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Ibandronate on Bone Loss Following Renal Transplantation.
Smerud KT, Dolgos S, et al.American Journal of Transplantation 2012 [record in progress].
Aims
To evaluate the effect of intravenous ibandronate on bone loss following renal transplantation.
Interventions
Intravenous ibandronate 3mg versus intravenous placebo every 3 months during 12 months. All patients were given oral calcitriol 0.25 mcg/day, calcium 500mg bid, intravenous basiliximab induction and immunosuppressive therapy consisting of a calcineurin inhibitor (cyclosporine or tacrolimus), prednisolone and mycophenolate mofetil.
Participants
129 renal transplant recipients with early stable renal function (≤ 28 days post-transplantation, GFR ≥ 30 mL/min).
Outcomes
Primary outcome was relative change in bone mineral density (BMD) in the lumbar spine (L2–L4) from baseline to 12 months. Secondary outcomes included BMD in other compartments (total femur, ultradistal radius, proximal 1/3 radius and total body); biochemical markers of bone variables included Type I procollagen (N-terminal) PINP, osteocalcin, bone-specific alkaline phosphatase, collagen type 1 cross-linked N-telopeptide, iPTH, 25-OH vitamin D. Safety and tolerability assessment included adverse events, serious adverse events, biopsy verified transplant rejections, level of serum creatinine,
Follow-up
12 months
CET Conclusions
IV ibandronate, compared to placebo in a randomised and double blinded study, was not associated with improved preservation of lumbar spine bone mineral density (assessed by DXA-scan). In both the study and control group lumbar spine bone mineral density actually improved, which may be associated with the calcium and calcitriol administered to both groups. Corticosteroid use is now less frequent than it was at the time of the studies on which the power calculation was based and this may partly explain the preserved bone density. Femoral and radial bone mineral density was higher in the study group than the placebo group, although the clinical significance of this is unclear. The study was not powered to assess for differences in fracture rates.
Data analysis
Strict intention-to-treat analysis
Trial registration
NCT00423384 (ClinicalTrials.gov); EudraCT 2006-003884-30.