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Pamidronate in the prevention of bone loss after liver transplantation: a randomized controlled trial |
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| Authors: | Ana Monegal Núria Guañabens María Jesús Suárez Francisco Suárez Gerardo Clemente Miguel García-González Manuel De la Mata Trinidad Serrano Fernando Casafont Santiago Torne Cesar Barrios Miquel Navasa |
| Institution: | Department of Rheumatology, Hospital Clínic i Provincial, Barcelona, Spain; Liver Transplantation Unit, Hospital de Cruces, Bilbao, Spain; Liver Transplantation Unit, Hospital Juan Canalejo, La Coruña, Spain; Liver Transplantation Unit, Hospital Gregorio Marañón, Madrid, Spain; Department of Gastroenterology, Hospital Ramón y Cajal, Madrid, Spain; Liver Transplantation Unit, Hospital Reina Sofía, Córdoba, Spain; Liver Transplantation Unit, Hospital Lozano Blesa, Zaragoza, Spain; Gastroenterology and Hepatology Unit, Hospital Marqués de Valdecillas, Santander, Spain; Liver Transplantation Unit, Hospital Clínico de Santiago, Santiago de Compostela, Spain; Liver Transplantation Unit, Clínica Puerta de Hierro, Madrid, Spain; Liver Unit, Hospital Clínic i Provincial, Barcelona, Spain |
| 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 (L2–L4) 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. |
| Keywords: | bisphosphonates bone loss liver transplantation pamidronate |