title: A 1-year randomized, double-blind, placebo-controlled study of intravenous ibandronate on bone loss following renal transplantation.
abstract: The clinical profile of ibandronate as add-on to calcitriol and calcium was studied in this double-blind, placebo-controlled trial of 129 renal transplant recipients with early stable renal function (≤ 28 days posttransplantation, GFR ≥ 30 mL/min). Patients were randomized to receive i.v. ibandronate 3 mg or i.v. placebo every 3 months for 12 months on top of oral calcitriol 0.25 mcg/day and calcium 500 mg b.i.d. At baseline, 10 weeks and 12 months bone mineral density (BMD) and biochemical markers of bone turnover were measured. The primary endpoint, relative change in BMD for the lumbar spine from baseline to 12 months was not different, +1.5% for ibandronate versus +0.5% for placebo (p = 0.28). Ibandronate demonstrated a significant improvement of BMD in total femur, +1.3% versus -0.5% (p = 0.01) and in the ultradistal radius, +0.6% versus -1.9% (p = 0.039). Bone formation markers were reduced by ibandronate, whereas the bone resorption marker, NTX, was reduced in both groups. Calcium and calcitriol supplementation alone showed an excellent efficacy and safety profile, virtually maintaining BMD without any loss over 12 months after renal transplantation, whereas adding ibandronate significantly improved BMD in total femur and ultradistal radius, and also suppressed biomarkers of bone turnover. Ibandronate was also well tolerated.
authors.affiliation: Section of Nephrology, Oslo University Hospital, Rikshospitalet, Oslo, Norway. knut.smerud@smerud.com
authors.forename: K T
authors.initials: KT
authors.lastname: Smerud
authors.forename: S
authors.initials: S
authors.lastname: Dolgos
authors.forename: I C
authors.initials: IC
authors.lastname: Olsen
authors.forename: A
authors.initials: A
authors.lastname: Åsberg
authors.forename: S
authors.initials: S
authors.lastname: Sagedal
authors.forename: A V
authors.initials: AV
authors.lastname: Reisæter
authors.forename: K
authors.initials: K
authors.lastname: Midtvedt
authors.forename: P
authors.initials: P
authors.lastname: Pfeffer
authors.forename: T
authors.initials: T
authors.lastname: Ueland
authors.forename: K
authors.initials: K
authors.lastname: Godang
authors.forename: J
authors.initials: J
authors.lastname: Bollerslev
authors.forename: A
authors.initials: A
authors.lastname: Hartmann
mesh_terms: D061605:Administration, Intravenous; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000008:administration & dosage*; D001862:Bone Resorption / Q000188:drug therapy* / Q000209:etiology; D002117:Calcitriol / Q000008:administration & dosage; D002136:Calcium, Dietary / Q000008:administration & dosage; D004164:Diphosphonates / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000077557:Ibandronic Acid; D016030:Kidney Transplantation / Q000009:adverse effects*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy* / Q000209:etiology; D014815:Vitamins / Q000008:administration & dosage
chemical_list: D050071:Bone Density Conservation Agents; D002136:Calcium, Dietary; D004164:Diphosphonates; D014815:Vitamins; D002117:Calcitriol; D000077557:Ibandronic Acid