| Objective To evaluate the clinical efficacy and safety of recombinant human parathyroid hormone (1-34) [rhPTH (1-34)] in the treatment of osteoporosis (OP), and to compare that with the efficacy of elcatonin. Methods A total of 60 patients with primary OP were randomly divided into 2 groups: rhPTH (1-34) group (PTH group) and elcatonin group (CT group), with the ratio of 3:1. Patients in PTH group received a daily subcutaneous injection of 20μg rhPTH (1-34) for 18 months, while patients in CT group received a weekly intramuscular injection of 20U elcatonin for 12 months. The bone mineral density (BMD) of the lumbar vertebrae 2-4 (L2-4) and the femoral neck, blood calcium and phosphorus, urinary calcium, serum bone specific alkaline phosphatase (BSAP), and urinary c-terminal telopeptides of type I collagen (CTX-I) were detected before the treatment and at the 6th month, the 12th month, and the 18th month after the treatment. Results Compared with those at the baseline, BMD of L2-4 in PTH group increased significantly at the 6th, the 12th, and the 18th month after the treatment . BMD of the femoral neck increased significantly at the 18th month after the treatment , while BSAP increased significantly at the 6th month and the 12th month after the treatment, and the correction value of CTX-I increased significantly at the 6th month, the 12th month, and the 18th month. In CT group, BMD of the L2-4 increased significantly at the 12th month . BMD of the femoral neck increased significantly at the 12th month and the 18th month, while BSAP decreased significantly at the 12th month and the 18th month , and no significant difference of the correction value of CTX-I before and after the treatment was observed. The comparison between 2 groups showed that the improvement of BMD of the L2-4 and growth rate at the 6th month, the 12th month, and the 18th month in PTH group were higher than that in CT group . However, the increase of BMD of the femoral neck and growth rate at the 12th month and the 18th month in CT group were higher than that in PTH group. There was no significant difference of the rate of adverse events between 2 groups. Nevertheless, there was a transient hypercalcemia in PTH group. Conclusion The application of rhPTH (1-34) is safe and effective in the treatment of primary OP. It is superior to calcitonin on improving BMD of the vertebrae in onset time, growth rate, and growth range, but inferior to calcitonin on improving BMD of the femoral neck. |