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Background/Aims: Lanthanum carbonate (LC, FOSRENOL®) is an effective phosphate binder for which tolerability and a safety profile have been reported in haemodialysis patients. Patients from previous studies entered a 2-year extension, enabling assessment of efficacy and safety for up to 6 years of LC monotherapy. Methods: Patients from four previous trials entered this study. Results: Ninety-three patients started the extension, with 22 entering a sixth year of LC treatment. Two-thirds of all patients received LC doses of 2,250 or 3,000 mg/day. Reductions in serum phosphate and calcium × phosphate product were maintained for up to 6 years. There were no new or unexpected adverse events (AEs), and no increase in the incidence of events with increasing treatment exposure. Over the complete duration of therapy, treatment-related AEs occurred in 25.8% of patients and were primarily gastrointestinal in nature. No clinically relevant changes in liver function tests were observed and there was no evidence of adverse effects on the liver, bone or the central nervous system. Conclusions: LC monotherapy was effective and well tolerated for up to 6 years with no evidence of safety concerns or increased frequency of AEs.

Osteoporosis is known to occur in patients with kidney transplants, but limited information is available about the prevalence and causes of this complication. We asked all 330 patients with kidney transplants in our unit to participate in this study of whom 165 (50%) agreed to do so. The characteristics of the participating patients were similar to the remaining 165 nonparticipants. Seventy of 165 (42%) of the participants were women of whom 40 were postmenopausal in contrast to the men of whom only one was hypogonadal. Bone mineral density (BMD) was significantly reduced at the radius (Z score, ؊1.5) and femoral neck (Z score, ؊0.7), but the lumbar spine was normal. BMD was lower in women than men at all skeletal sites. Osteoporosis was found in 10 -44% and osteopenia was found in 35-50% of women depending on the site. BMD was related inversely to time since transplantation and cumulative prednisolone dose. Twenty-seven of the 165 (16%) patients had either vertebral deformities or a history of a low trauma fracture after transplantation. This fracture group consisted of 10/27 (37%) men and 17/27 (63%) women, of whom 14 were postmenopausal. Fracture patients tended to be older and have a longer duration of renal failure, dialysis, transplantation, greater cumulative steroid dose, and higher bone resorption markers than the nonfracture group. No differences were found for cumulative doses of cyclosporin or tacrolimus. Logistic regression showed that only duration of dialysis and time since transplantation significantly increased fracture risk, with odds ratio (OR) for each year of dialysis or transplantation being 1.21 (CI, 1.00 -1.48) and 1.14 (CI, 1.05-1.23), respectively. These data show that low bone density and fractures are common in patients with kidney transplant and are determined by both pre-and posttransplant variables. Fracture risk was greatest in women, particularly if they were postmenopausal and we recommend that this subgroup is targeted for assessment and treatment.

A high incidence of osteopenia is likely in renal transplant recipients in whom pre-existing uraemic osteodystrophy, persisting hyperparathyroidism and glucocorticoids constitute a formidable array of risk factors. The correction of some biochemical and hormonal abnormalities, an increase in body weight and an increase in physical activity following transplantation could favour improvements in skeletal integrity. Using dual energy X-ray absorptiometry (DEXA), we studied prospectively the regional bone mineral density (BMD) of 34 consecutive cadaveric renal allograft recipients who were already established on dialysis. BMD of these patients was measured at the time of transplantation and was repeated at 3, 6 and 12 months following the transplantation. Immunosuppression was achieved using triple therapy: azathioprine, cyclosporin-A and prednisolone. At baseline, total BMD and BMD at the lumbar spine and femoral neck did not differ from age- and sex-matched controls. Females experienced marked and progressive bone loss at the lumbar spine, with less marked changes at the femoral neck. Males, in contrast, experienced substantial reduction of BMD at the femoral neck at 6 months and a recovery at 12 months without significant change at the lumbar spine. Whole body bone mineral content fell transiently in males, with partial recovery by 6 months. No significant correlation was found with the cumulative doses of either corticosteroids or cyclosporin-A, the duration of hospitalisation, the function of the transplant, patient age or menopausal status. In females the loss of BMD at the lumbar spine at 6 months was closely associated with a high parathyroid hormone level (PTH) at transplantation, and in males, the loss of BMD at the femoral neck was associated with a low PTH level at transplantation. We conclude that rapid falls in BMD appear to be inherent to the process of renal transplantation and that strategies to prevent this loss should be evaluated.

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Renal-transplant recipients have an increased prevalence of leukoplakia, dysplasia, and cancer of the lip.

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