Prevalence and treatment of decreased bone density in renal transplant recipients: a randomized prospective trial of calcitriol versus alendronate.

BACKGROUND: Reduced bone mineral density (BMD) is common in long-term renal transplant recipients and results in a high incidence of fractures. The optimal therapy for these patients is not known.
METHODS: Baseline BMD determinations were obtained in 211 long-term adult renal transplant recipients. One hundred and seventeen patients with a reduced BMD (T score < or = -1) were randomly assigned to treatment with alendronate and calcium (n=60) versus calcitriol and calcium (n=57). Of these, 46 and 51 patients, respectively, completed 1 year of treatment. Forty-nine patients who were not eligible or did not consent to the trial were followed prospectively.
RESULTS: Reduced baseline BMD (T score < or = -1) was present in 159 (78.7%) of patients at the lumbar spine or femur. There was no significant loss of BMD in the prospectively followed patients during 2.7 years. The average lumbar BMD increased from 0.984+/-0.149 to 1.025+/-0.143 g/cm2 (P<0.001) with alendronate and from 1.014+/-0.15 to 1.034+/-0.146 g/cm2 (P=0.002) with calcitriol. BMD at the femur increased from 0.809+/-0.092 to 0.836+/-0.107 g/cm2 (P<0.001) with alendronate and from 0.830+/-0.144 to 0.857+/-0.125 g/cm2 (P=0.023) with calcitriol.
CONCLUSIONS: One year of treatment with alendronate or calcitriol, both with calcium supplementation, resulted in significant increases in BMD at the lumbar spine and femur, with a trend toward alendronate being more effective at the spine (P=0.082). Further studies are needed to determine whether BMDs continue to increase after 1 year and whether there is any additional benefit to combining vitamin D and alendronate. Larger studies are needed to determine whether treatment decreases fracture rates.

RCT Entities:   Population Interventions Outcomes