Efficacy of parathyroid hormone (1-34) and elcatonin in postmenopausal women with osteoporosis：A randomized and controlled trial for 18 months / 中华内分泌代谢杂志

Objective Recombinant human parathyroid hormone(1-34) [ rhPTH(1-34)] is the unique anabolic substance acting on the skeleton. The efficacy and safety of long-term administration of rhPTH(1-34) in Chinese postmenopausal women have not been evaluated. This study compared the clinical efficacy and safety of rhPTH(1-34) with elcatonin for treating postmenopausal women with osteoporosis in 11 urban areas of China. Methods A total of453 postmenopausal women with osteoporosis were enrolled in an 18-month, multi-center, randomized, controlled study. They were randomized to receive either rhPTH(1-34) 20 μg(200 U) daily for 18 months, or elcatonin 20 U weekly for 12 months. Lumbar spine ( L1-4) and femoral neck bone mineral density (BMD), fracture rate, back pain as well as biochemical markers of bone turnover ( serum bone-specific alkaline phosphatase was measured by radioimmunoassay; C-telopeptide/ creatinine ( CTX/ Cr) measured by quantitative sandwich enzyme-linked immunosorbent assay) at 6, 12, and 18 months. Adverse events were recorded. Results rhPTH(1-34) increased lumbar BMD more significantly than that did by elcatonin at 6 months( M6), 12 months (M12), and 18 months(M18; 4. 3% vs 1. 94% , 6. 8% vs 2. 72% , 9. 51% vs 2. 86% , P<0. 01). There was only a small but significant increase of femoral neck BMD at M18(2. 64% , P<0. 01) in rhPTH(1-34) groups. There were greater increases in bone turnover markers in the rhPTH(1-34) group than in the elcatonin group at M6, M12, and M18[serum bone-specific alkaline phosphatase(BSAP) 93. 67% vs -3. 56% , 117. 78% vs -4. 12% , 49. 24% vs-5. 81% , P<0. 01; urinary CTX/ Cr 250% vs -29. 5% , 330% vs -41. 4% , 273 % vs -10. 6% , P<0. 01]. rhPTH (1-34) showed similar effect of pain relief as elcatonin. The incidence of clinical fractures was 5. 36% (6 / 112) in elcatonin group and 3. 23% ( 11 / 341 ) in rhPTH ( 1-34 ) group ( P = 0. 303 ). Both treatments were well tolerated. Hypercaluria(9. 38% ) and hypercalcemia(7. 04% ) in rhPTH(1-34) group was transient and caused no clinical symptoms. Pruritus(8. 21% vs 2. 68, P=0. 044) and redness of injection site(4. 40% vs 0, P=0. 024) were more frequent in rhPTH(1-34). Nausea / vomiting(16. 07% vs 6. 16% , P = 0. 001) and hot flushes(7. 14% vs 0. 59% , P<0. 001) were more common in elcatonin group. Conclusion rhPTH(1-34) treatment was associated with greater increases in lumbar spine BMD and bone formation markers. It could increase femoral BMD after 18 months treatment. rhPTH(1-34) could ameliorate back pain effectively. The results of the present study indicate that rhPTH(1-34) is an effective, and safe agent in treating postmenopausal women with osteoporosis.

Comparison of several early drug interventions in postmenopausal women with osteopenia / 中华内分泌代谢杂志

Two hundreds postmenopausal women with osteopenia, aged 45-80, were randomly divided into 4 groups, and received different drug interventions. After treatment for 12 months, the lumbar spine bone mineral density(BMD)and total hip BMD in alendronate group increased significantly(3.5% and 2.6%, both P＜0.05), the lumbar spine BMD raised 2.0% in selective estrogen receptor regulator group(P＜0.05). Bone turnover indices improved in both groups(all P＜0.05). No change in BMD or bone turnover indices was found in patients treated with active vitamin D3and calcium.

Risk factor analysis for postmenopausal osteoporosis in Shanghai / 中华老年医学杂志

Objective To investigate the risk factors for postmenopausal osteoporosis in Shanghai.Methods Five hundred postmenopausal community-dwelling women aged 45-80 years were recruited. The case-control study was performed from June 2008 to September 2008.A total number of 250 women with postmenopausal osteoporosis identified with their bone mineral density (BMD) were selected as case group, and 250 non-osteoporosis women were selected as control group. BMD was measured by dual energy X-ray absorption (DEXA). Results Univariate logistic regression analysis showed that age, eduction level, occupation, years since menopause, BMI, use of calcium,historyofnon-violencefracture,fall,diabetesmellitus,chronicgastricdiseases, gastrointestinal resection and diarrhea were related to osteoporosis.Multiple logistic regression showed that age, years since menopause and nutritional status were the risk factors for osteoporosis. ConclusionsThe occurrence of osteoporosis is related with many factors in postmenopausal women in Shanghai, and women with early menopause, low BMI and older age should pay more attention to the prevention and treatment of osteoporosis.

The follow-up study of therapeutic effects of alendronate sodium on osteoporosis / 中华老年医学杂志

Objective To study early changes in biochemical markers of bone turnover for prodicting the bone mineral density(BMD) response to alendronate therapy in Chinese men with osteoporosis. Methods Seventy-eight men aged 60 to 82 years with osteoporosis [mean age (69.8 ±11.8) years]were treated with alendronate sodium 70 mg/week for 12 months. Serum bone gla-protein (BGP) and serum pyridinoline-eross-linked earboxyterminal telopeptide of type I collagen (ICTP) level were measured by chemiluminescence (equipment is Roche E170). Serum BGP, ICTP and BSALP levels were measured before and 3 months and 12 months after treatment. BMD in lumbar spine and femoral neck were measured with dual energy X-ray absorptiometry (GE PRODIGY Inc. ) at L1-4 and at the left hip(total hip,trochanter,Ward's area and femoral neck)before and 12 months after treatment. Results After 3-months and 12-months treatment, the percent reductions of serum ICTP levels were 45.8% and 51.6%, serum BGP level 32.0% and 37.5%, serum BSALP level 35. 3% and 39.9% ,respectively. After 12-months treatment, the percent increase of lumbar BMD was 11.8%, femoral neck BMD 11.4 %. The percent reductions of serum ICTP level at months 3 and 12 after treatment were positively correlated to the percent increase of lumbar BMD (r=0.28, 0.295,P <0.05 and P<0.01)and of fermoral neck BMD at 12 months after treatment(r=0.262, 0.333, P＜0.05 and P<0.01)respectively. The percent reductions of serum BGP level at months 3 and 12 after treatment were positively correlated to the percent increase of lumbar BMD (r=0. 322, 0.401,all P<0.01) and of fermoral neck BMD at 12 months after treatment (r=0.277,0.284, all P＜0.05)respectively. The percent reductions of serum BSALP level at months 3 and 12 after treatment were positively correlated to the percent increase of lumbar BMD (r=0.133,0.231,all P＜0.05) and of fermoral neck BMD at 12 months after treatment(r=0.248, 0.317, all P＜0.01)respectively.Conclusions Early changes in biochemical markers of bone turnover rates can predict BMD response to alendronate in Chinese men with osteoporosis.

Efficacy, safety and acceptance of Acarbose treatment under day-to-day clinical practice conditions: Post-Marketing Surveillance in Chinese type 2 diabetic patients / 中华内分泌代谢杂志

The aim of this Post-Marketing Surveillance study was to assess efficacy, safety and acceptance of acarbose treatment in Chinese type 2 diabetic patients under day-to-day practice conditions. A total of 2 480 patients were enrolled by 231 physicians throughout China into an open, prospective, uncontrolled, nonrandomised, multi-centre study. Main efficacy parameters were the changes in fasting and postprandial blood glucose concentrations as well as in HbA1c levels after acarbose treatment. The majority of patients had been previously treated with other oral anti-diabetic medication or insulin and received concomitant anti-diabetics during the mean observation period of 13.5 weeks. Most patients started on a daily acarbose dose of 50 mgt. i. d. Acarbose treatment reduced fasting blood glucose concentrations by 56. 1 mg/dl ( 18 mg/dl glucose = 1 mmol/Lglucose) and 2h-postprandial values by 111.3 mg/dl over the studyperiod. HbA1c decreased by 1.9％ and body weight by 0.9 kg. 76 acarbose-related adverse events occurred; two patients experienced serious adverse events.The attending physicians assessed treatment efficacy as "very good" or "good" for 90.1％ of the patients, tolerability for 89.1％ and acarbose acceptance for 87.1％ of the patients. Acarbose is efficacious, safe and well accepted by Chinese type 2 diabetic patients under day-to-day routine conditions, both as anti-diabetic mono therapy and in combination with other anti-diabetic drugs.

A survey of diabetes prevalence in 9376 urbanite adults or Shanghai / 中国糖尿病杂志

Objective To survey the prevalence of diabetes mellitus in adults of urban inhabitants of Shanghai. Methods Of 9376 adults aged 30 years and over, 1137 whose capillary blood glucose concentrations≥6. 7mmol/L 2 hours after 100g steam-bread meal underwent to OGTT and measurement of height.body weight and WHR. WHO (1985) standard was used as diagnostic criteria, the results were compared with those diagnosed with ADA (1997) criteria. Results According to WHO criteria,the prevalence rates of DM was 4. 16 %,and the prevalence rate of IGT was 4. 26%. But according to ADA(1997) criteria, the prevalence rate of DM was 4. 76%. The prevalence rate of DM and IGT were significantly increased with increasing age in those aged over 40. The prevalence rates of DM and IGT were much higher in patients with BMI≥25 than in those with BMI