The Therapeutic Effect Of Recombinant Human Parathyroid Hormone﹙1-34﹚in Postmenopausal Women With Osteoporosis

Objective: Osteoporosis is one of the common metabolic bone diseases. 29 postmenopausal women with osteoporosis were included. This study is to evaluate the therapeutic efficacy (calcium, phosphorus, alkaline phosphates and the right femoral neck and lumbar spine bone density) and its safety (blood pressure, heart rate, blood and urine routine, liver function, kidney function, blood sugar, ECG, etc.) of recombinant human parathyroid hormone (1-34), which is a new kind of clinical drugs for osteoporosis, on postmenopausal women with osteoporosis, treatment for up to 12 months.Methods: A total of 29 subjects with established postmenopausal osteoporosis were included. All subjects were aged from51-79(69±8 years)years old, and menopause years(MPY) were from 2 to 35 years. All were treat–ed with recombinant human parathyroid hormone (1-34) and Calcichew D. One because of anaphylactic response was exited. The treatments of the others lasted for one year. Lumbar spine (L2–4) and right femoral neck bone mineral density (BMD), serum calcium, serum phosphate and serum alkaline phosphatase, as well as biochemical markers of safty, blood pressure, and heart rate and so on were measured. Adverse events were recorded in this year. The experimental data was presented as mean±standard deviation. Analysis were used to check differences between groups by SPSS12.0,P<0.05 was considered statistically significant.Results:1 At the study endpoint the height and weight and BMI did not change significantly (P>0.05).2 Treated with recombinant human parathyroid hormone (1-34) combined with Calcichew D give the patients with postmenopausal osteoporosis relief from pain: 20 of 28 patients were in remission, and the remission rate was 71.4%.3 rhPTH (1-34) increased lumbar spine and femoral neck BMD at the study endpoint. From baseline to endpoint, rhPTH (1-34) increased L2–4 and femoral neck BMD by 6.5% (P<0.01) and 10.0% (P<0.05) at half of year, and increased L2–4 and femoral neck BMD by 6.9% (P<0.05) and 10.3% (P <0.05) .But the BMD of 6 months to 12 months did not change significantly (P >0.05).4 Mean serum calcium concentration increased at 6 and 12 months in the patients compared with baseline. It was 4.5% higher at 6 months than baseline (P<0.01). Following this, there was a increase in measured serum calcium at 12 months as compared with the baseline (P<0.05) and with at 6 months (P<0.05). Mean serum phosphate concentration increased at 6 and 12 months in the patients compared with baseline. The serum phosphate was 8.3% higher than baseline (P<0.05). Following this, there was a decrease in measured serum phosphate at 12 months as compared with the level at 6 months (P >0.05)and with baseline (P>0.05). The serum alkaline phosphates did not change significantly (P>0.05).5 Only 1 patient withdrew from the study because of an adverse event. The reason for withdrawal was hypersensitiveness. There were no changes significantly(P>0.05) in blood pressure, heart rate, blood and urine routine, liver function, kidney function, blood sugar, ECG and so on. And it is well tolerated, effective, and safe.Conclusions: rhPTH (1-34) increases lumbar and femoral neck BMD of the patients significantly at 6 months and 12 months, shows significant anabolic effects on bone, and decreases the risk of vertebral and nonvertebral fractures, and improves the quality of life, and is well tolerated. There is little adverse events and serious adverse events. The results of the present study tentatively indicate that rhPTH (1-34) is an effective, safe agent in treating postmenopausal osteoporosis.