A J Freemont1, J A Hoyland, J Denton. 1. Osteoarticular Pathology, The Medical School, University of Manchester, UK. tony.freemont@man.ac.uk
Abstract
BACKGROUND: Renal osteodystrophy is a common complication of end-stage renal disease (ESRD) and is a major cause of morbidity in patients with ESRD. High serum levels of phosphorus, calcium and parathyroid hormone are associated with the development of this disease. The effects on bone of treatment with lanthanum carbonate, a new phosphate binder, and calcium carbonate were assessed in patients with ESRD. METHODS: This was an open-label, multicenter, parallel-group study. Patients were recruited within 12 weeks of commencing dialysis. Following screening, phosphate binder administration was stopped, tetracycline labeling administered and a transiliac bone biopsy taken. After randomization to lanthanum carbonate or calcium carbonate, patients were titrated to an optimum dose for 8 weeks and maintained at this dose for 44 weeks. The bone was then labeled and a second biopsy taken. Biopsy samples were analyzed histomorphometrically. RESULTS: Paired bone biopsies from 33 lanthanum carbonate- and 30 calcium carbonate-treated patients were suitable for analysis. None of the patients on either treatment developed osteomalacia. Assessment of activation frequency changes showed that 41% of biopsies from lanthanum carbonate-treated patients moved towards normal (observed values at the follow-up biopsy were closer to expected values than were the baseline values, so patients were considered to be improved) compared with 23% of calcium carbonate-treated patients (p = 0.15). CONCLUSIONS: This study indicates that there was no evidence of aluminum-like toxicity with lanthanum carbonate after 1 year of treatment in ESRD patients commencing dialysis, and there appeared to be a beneficial effect on bone-cell function and activity compared with calcium carbonate.
RCT Entities:
BACKGROUND:Renal osteodystrophy is a common complication of end-stage renal disease (ESRD) and is a major cause of morbidity in patients with ESRD. High serum levels of phosphorus, calcium and parathyroid hormone are associated with the development of this disease. The effects on bone of treatment with lanthanum carbonate, a new phosphate binder, and calcium carbonate were assessed in patients with ESRD. METHODS: This was an open-label, multicenter, parallel-group study. Patients were recruited within 12 weeks of commencing dialysis. Following screening, phosphate binder administration was stopped, tetracycline labeling administered and a transiliac bone biopsy taken. After randomization to lanthanum carbonate or calcium carbonate, patients were titrated to an optimum dose for 8 weeks and maintained at this dose for 44 weeks. The bone was then labeled and a second biopsy taken. Biopsy samples were analyzed histomorphometrically. RESULTS: Paired bone biopsies from 33 lanthanum carbonate- and 30 calcium carbonate-treated patients were suitable for analysis. None of the patients on either treatment developed osteomalacia. Assessment of activation frequency changes showed that 41% of biopsies from lanthanum carbonate-treated patients moved towards normal (observed values at the follow-up biopsy were closer to expected values than were the baseline values, so patients were considered to be improved) compared with 23% of calcium carbonate-treated patients (p = 0.15). CONCLUSIONS: This study indicates that there was no evidence of aluminum-like toxicity with lanthanum carbonate after 1 year of treatment in ESRDpatients commencing dialysis, and there appeared to be a beneficial effect on bone-cell function and activity compared with calcium carbonate.
Authors: Christoph Pautke; Stephan Vogt; Kilian Kreutzer; Cornelia Haczek; Gabriele Wexel; Andreas Kolk; Andreas B Imhoff; Horst Zitzelsberger; Stefan Milz; Thomas Tischer Journal: J Anat Date: 2010-04-26 Impact factor: 2.610