title: Pamidronate in the prevention of bone loss after liver transplantation: a randomized controlled trial.
abstract: Rapid bone loss and high rates of fractures occur following liver transplantation. To analyze the effect of intravenous pamidronate on bone loss after liver transplantation. A randomized, double-blind, placebo-controlled study was performed. Seventy-nine patients were randomized to two groups of treatment: the pamidronate group (n = 38) was treated with 90 mg/IV of pamidronate within the first 2 weeks and at 3 months after transplantation; the placebo group (n = 41) received glucose infusions at the same time points. All patients received calcium and vitamin D. Bone mineral density (BMD) at the lumbar spine (L(2)-L(4)) and proximal femur using dual energy X-ray absorptiometry and also spinal X-rays were performed before, and at 6 and 12 months after liver transplantation. Biochemical and hormonal determinations were performed previous to transplantation, at 24 h before and after treatment, as well as at 6 and 12 months after liver transplantation. At 12 months after transplantation, there were significant differences in lumbar BMD changes (6 months: pamidronate 1.6% vs. placebo 0.8%, P = NS; 12 months: pamidronate 2.9% vs. placebo 1%, P < 0.05). Femoral neck BMD decreased in the pamidronate- and placebo groups during the first 6 months (6 months: pamidronate -3.1% vs. placebo -2.9%, P = NS; 12 months: pamidronate -3.2% vs. placebo -3.1%, P = NS). BMD at the trochanter remained stable in the pamidronate group, whilst a reduction was observed in the placebo group at 6 months (6 months: pamidronate -0.7% vs. placebo -3.7%, P < 0.05; 12 months: pamidronate -0.5% vs. placebo -1.2%, P = NS). Moreover, no significant differences in the incidence of fractures, serum parathyroid hormone and serum 25-hydroxyvitamin D values between both groups were found. Pamidronate did not increase the risk of serious adverse events. The results of this study show that 90 mg of intravenous pamidronate within the first 2 weeks and at 3 months following liver transplantation preserve lumbar bone mass during the first year, without significant adverse events. However, pamidronate does not reduce bone loss at the femoral neck and furthermore it does not reduce skeletal fractures.
authors.affiliation: Department of Rheumatology, Hospital Clínic i Provincial, Barcelona, Spain. 21607amb@comb.es
authors.forename: Ana
authors.initials: A
authors.lastname: Monegal
authors.forename: Núria
authors.initials: N
authors.lastname: Guañabens
authors.forename: María Jesús
authors.initials: MJ
authors.lastname: Suárez
authors.forename: Francisco
authors.initials: F
authors.lastname: Suárez
authors.forename: Gerardo
authors.initials: G
authors.lastname: Clemente
authors.forename: Miguel
authors.initials: M
authors.lastname: García-González
authors.forename: Manuel
authors.initials: M
authors.lastname: De la Mata
authors.forename: Trinidad
authors.initials: T
authors.lastname: Serrano
authors.forename: Fernando
authors.initials: F
authors.lastname: Casafont
authors.forename: Santiago
authors.initials: S
authors.lastname: Tome
authors.forename: Santiago
authors.initials: S
authors.lastname: Torne
authors.forename: Cesar
authors.initials: C
authors.lastname: Barrios
authors.forename: Miquel
authors.initials: M
authors.lastname: Navasa
mesh_terms: D000328:Adult; D000368:Aged; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001862:Bone Resorption / Q000209:etiology / Q000517:prevention & control*; D004164:Diphosphonates / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016031:Liver Transplantation / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D000077268:Pamidronate; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D000077268:Pamidronate