A randomized, multicenter, active-controlled trial to compare the efficacy of recombinant human parathyroid hormone (1-34) with that of elcatonin in postmenopausal women with osteoporosis in China / 中华内科杂志

ABSTRACT

Objective To compare the clinical efficacy and safety between recombinant human parathyroid hormone ( rhPTH) ( 1 -34) and elcatonin in the treatment of postmenopausal women with osteoporosis in China.Methods This 6 month, multicenter, randomized and controlled study enrolled 205 postmenopausal women with osteoporosis.They were randomized to receive either rhPTH (1 -34) 20 μg (200 U) daily or elcatonin 20 U weekly.Lumbar spine (L1-4 ) and femoral neck bone mineral density (BMD) and biochemical markers of bone turnover were measured. In the meantime adverse events were recorded. Results The results showed that both rhPTH ( 1 -34) and elcatonin increased L1-4 BMD significantly at the endpoint of the study, but femoral neck BMD did not change significantly.From baseline to endpoint, BMD of L1-4 and femoral neck in the rhPTH( 1-34) group increased by 5.51% (P <0.01) and 0.65% (P >0.05), but BMD of L1-4 and femoral neck in elcatonin group increased by 1.55% (P <0.05) and 0.11% (P>0.05).Moreover, the rhPTH(1-34) group had better improvement in L1-4 BMD than the elcatonin group at 3, 6 months, but there was no difference of BMD in these two groups with regard to femoral neck.There were greater mean increases of the bone markers in the rhPTH( 1-34) group than those in the elcatonin group at 3, 6 months [serum bone-specific alkaline phosphatase ( BSAP) 36.79% vs 0.31% ; 92.42% vs -0.17% ; the ratio of urine N-telopeptide of type I collagen and creatinine (NTX/Cr) 48.91% vs -5.32% ; 68.82% vs - 10.86%].Both kinds of treatment were well tolerated and there were no differences between the two groups in the rates of adverse events and serious adverse events.Conclusion It is concluded that rhPTH (1 -34) has more positive effects on bone formation than elcatonin as shown by the greater increments of L1-4 BMD and bone formation markers and the less occurrence of adverse events as well as no significant change in hepatic, renal or hemopoietic function.