Background: Renal osteodystrophy is one of the commonest complications of chronic renal failure. It may have a severe impact on the quality of life of patients on maintenance dialysis therapy. Besides post-menopausal women and elderly people, the dialysis patients are another high risk group. But at present, there is no research on how to prevent osteoporosis in maintenance dialysis patients. This study was conducted to observe the bone density of maintenance dialysis patients and to evaluate the clinical outcomes and safety of different administration dosage of salmon calcitonin to prevent osteoporosis in maintenance dialysis patients.
Methods: One hundred and forty-eight patients on maintenance dialysis were involved in the 12-month, randomized, controlled trial. Fifty patients (experiment I group) received subcutaneous injection of salmon calcitonin (50 U) three times a week for 12 months. Fifty patients (experiment II group) received subcutaneous injection of salmon calcitonin (100 U) three times a week for 12 months. At the same time, both of them received oral calcium carbonate 1500 mg tid and rocaltrol 0.25 microg qn for 12 months. The control group only received oral calcium carbonate 1500 mg tid and rocaltrol 0.25 microg qn for 12 months. The levels of bone mass density (BMD) of the lumbar spine and femoral neck, serum intact parathyroid hormone (iPTH), osteocalcin (OC), calcium, phosphorus, alkaline phosphatase (ALP) were assessed at baseline and then again after 3, 6 and 12 months of treatment.
Results: The values of BMD at the lumbar spine and femoral neck before the treatment were not significantly different from those 3, 6, and 12 months after the treatment in trial groups I and II (all P > 0.05) and there were no significant differences in the BMD values at different time points between trial groups I and II. In the control group, the BMD values at the lumbar spine and femoral neck 3, 6, and 12 months after the beginning of trial were significantly lower than those before the trial, and significantly lower than the corresponding values of trial groups I and II (all P < 0.05). The serum OC 3, 6, and 12 months after the treatment was significantly lower than that before the experiment (all P < 0.05) in the control group. However, there was no significant difference in the value of serum OC before and 3, 6, and 12 months after the treatment in trial groups I and II (all P > 0.05).
Conclusions: The dose of salmon calcitonin 50 U three times a week plus calcium carbonate and active vitamin D can effectively preserve the BMD and prevent bone loss in maintenance dialysis patients, and it is well tolerated by patients on maintenance dialysis.