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Objective To observe the clinical efficacy ofErxian Decoction combined with elcatonin for the treatment of postmenopausal osteoporosis.Methods Eighty cases of female patients with postmenopausal osteoporosis were randomly divided into treatment group and control group, 40 cases in each group. The control group received intramuscular injections elcatonin treatment, and the treatment group received oralErxian Decoction on the basis of the treatment of the control group, for 12 weeks. The main clinical symptom score, VAS score and bone mineral density (BMD) of L2-L4 and in the tibia of the two groups were observed before and after treatment to assess the therapeutic effect.Results After treatment, VAS scores of the two groups were significantly lower (P<0.05). The total effective rate of the treatment group was 92.5% (37/40); the control group was 75.0 (30/40), with statistical significance (P<0.05). The treatment group was significantly better than the control group in main symptom scores, especially in improving body symptoms (P<0.05). BMD of the treatment group was significantly higher than the control group.ConclusionErxian Decoction combined with elcatonin therapy for postmenopausal women with osteoporosis can significantly improve clinical symptoms and increase BMD.
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OBJECTIVE@#To evaluate the efficacy and safety of rhPTH (1-34) vs. elcatonin.@*METHODS@#Sixty patients with primary OP were randomly divided into two groups according to the ratio of 3:1. rhPTH (1-34) group (PTH group) was treated with subcutaneous injection of rhPTH (1-34) 20 μ g daily for 18 months, and the elcatonin group (CT group) was treated with intramuscular injection of elcatonin 20 U weekly for 12 months. Bone mineral density (BMD) of the lumbar spine 2-4 (L2-4) and femoral neck, serum calcium and phosphorus, urinary calcium, serum bone specific alkaline phosphatase (BSAP), and urinary c-terminal telopeptides of type I collagen/creatinine (uCTX-I/Cr) were tested at baseline, and 6, 12, and 18 months after treatment.@*RESULTS@#In PTH group, BMD of L2-4 at 6, 12, and 18 months, BDM of femoral neck at 18 month, BSAP at 6 and 12 months and uCTX- I/Cr at 6, 12 and 18 months were all significantly raised. In CT group, BMD of L2-4 at 12 month and that of femoral neck at 12 and 18 months were significantly elevated, while BSAP was significantly decreased at 12 and 18 months, and no significant difference on CTX- I/Cr was observed. When BMD growth and growth rate between two groups were compared, PTH group had better improvement in L2-4 BMD and growth rate than CT group at 6, 12, and 18 months. BMD growth and growth rate of femoral neck at 12 month and its growth at 18 month in CT group were higher than in PTH group, but there was no significant difference between two groups regarding the growth rates at 18 month. Besides, there were no significant differences regarding the rates of adverse reactions between two groups.@*CONCLUSIONS@#rhPTH (1-34), is safe and effective in the treatment of primary OP. It is superior to elcatonin in improving vertebral BMD at onset time, growth rate and growth range, but inferior to elcatonin at BMD of femoral neck.
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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.
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Objective:To evaluate the efficacy and safety of rhPTH(1-34)vs. elcatonin.Methods:Sixty patients with primaryOP were randomly divided into two groups according to the ratio of3:1. rhPTH(1-34) group(PTH group) was treated with subcutaneous injection of rhPTH(1-34)20 μg daily for18 months, and the elcatonin group(CT group) was treated with intramuscular injection of elcatonin20U weekly for12 months.Bone mineral density(BMD) of the lumbar spine2-4(L2-4) and femoral neck, serum calcium and phosphorus, urinary calcium, serum bone specific alkaline phosphatase(BSAP), and urinary c-terminal telopeptides of type Ⅰ collagen/creatinine(uCTX-Ⅰ/Cr) were tested at baseline, and6,12, and18 months after treatment.Results:InPTH group, BMD ofL2-4 at6,12, and18 months,BDM of femoral neck at18 month,BSAP at6 and12 months and uCTX-Ⅰ/Cr at6,12 and18 months were all significantly raised.InCT group,BMD ofL2-4at 12 month and that of femoral neck at12 and18 months were significantly elevated, whileBSAP was significantly decreased at12 and18 months, and no significant difference onCTX-Ⅰ/Cr was observed.WhenBMD growth and growth rate between two groups were compared,PTH group had better improvement inL2-4BMD and growth rate thanCT group at6,12, and18 months.BMD growth and growth rate of femoral neck at12 month and its growth at18 month inCT group were higher than inPTH group, but there was no significant difference between two groups regarding the growth rates at18 month.Besides, there were no significant differences regarding the rates of adverse reactions between two groups.Conclusions: rhPTH(1-34), is safe and effective in the treatment of primaryOP.It is superior to elcatonin in improving vertebralBMD at onset time, growth rate and growth range, but inferior to elcatonin atBMD of femoral neck.
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Objective: To evaluate the efficacy and safety of rhPTH (1-34) vs. elcatonin. Methods: Sixty patients with primary OP were randomly divided into two groups according to the ratio of 3:1. rhPTH (1-34) group (PTH group) was treated with subcutaneous injection of rhPTH (1-34) 20 μ g daily for 18 months, and the elcatonin group (CT group) was treated with intramuscular injection of elcatonin 20 U weekly for 12 months. Bone mineral density (BMD) of the lumbar spine 2-4 (L2-4) and femoral neck, serum calcium and phosphorus, urinary calcium, serum bone specific alkaline phosphatase (BSAP), and urinary c-terminal telopeptides of type I collagen/creatinine (uCTX-I/Cr) were tested at baseline, and 6, 12, and 18 months after treatment. Results: In PTH group, BMD of L2-4 at 6, 12, and 18 months, BDM of femoral neck at 18 month, BSAP at 6 and 12 months and uCTX- I/Cr at 6, 12 and 18 months were all significantly raised. In CT group, BMD of L2-4 at 12 month and that of femoral neck at 12 and 18 months were significantly elevated, while BSAP was significantly decreased at 12 and 18 months, and no significant difference on CTX- I/Cr was observed. When BMD growth and growth rate between two groups were compared, PTH group had better improvement in L2-4 BMD and growth rate than CT group at 6, 12, and 18 months. BMD growth and growth rate of femoral neck at 12 month and its growth at 18 month in CT group were higher than in PTH group, but there was no significant difference between two groups regarding the growth rates at 18 month. Besides, there were no significant differences regarding the rates of adverse reactions between two groups. Conclusions: rhPTH (1-34), is safe and effective in the treatment of primary OP. It is superior to elcatonin in improving vertebral BMD at onset time, growth rate and growth range, but inferior to elcatonin at BMD of femoral neck.
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STUDY DESIGN: Multicenter prospective study with a crossover design. PURPOSE: The objective of this study is to compare the efficacy of limaprost alfadex (LP) and elcatonin (EL) for lumbar spinal stenosis (LSS) patients with concurrent osteoporosis. OVERVIEW OF LITERATURE: It has been increasingly important to improve quality of life by establishing appropriate conservative treatments for LSS patients with concurrent osteoporosis who will presumably continue to increase due to the percentage of the aging elevations, however there is no prospective study. METHODS: A total of 19 patients with LSS and concurrent osteoporosis were enrolled in this study. The patients were divided into two groups and compared using a crossover design. The Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) and short-form (SF)-8 health survey scale were used for clinical evaluations. RESULTS: There was a significant improvement of buttock-leg pain and numbness in the EL group. A significant improvement of impaired walking function was noted for the LP group according to the JOABPEQ while the rest of the items in the JOABPEQ showed no significant differences. The SF-8 health survey revealed that somatic pains and physical summary scores in the EL group and physical functioning and physical summary scores in the LP group tended to improve but not to any statistically significant extents. CONCLUSIONS: Concomitant uses of EL may be useful in patients who do not respond satisfactorily to the treatments of LP for 6-8 weeks.
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Humans , Aging , Asian People , Back Pain , Cross-Over Studies , Drug Therapy , Health Surveys , Hypesthesia , Nociceptive Pain , Osteoporosis , Prospective Studies , Quality of Life , Spinal Stenosis , Walking , Surveys and QuestionnairesABSTRACT
ObjectiveTo investigate the effect of rhPTH (1-34) and elcatonin on bone metabolism and serum secreted protein acidic and rich in cysteine ( SPARC ) in postmenopausal women with osteoporosis.Methods One hundred and twenty-four postmenopausal women with osteoporosis were randomly divided into 2 groups:One group was treated with recombinant human parathyroid hormone ( 1-34 ) [ rhPTH ( 1-34 ) ] 200 U/d by subcutaneous injection (PTH group,n =89 )and another group was treated with elcatonin 20 U/week by intramuscular injection (CT group,n =35 ) for 12 months.All patients received a basic therapy with oral calcium ( Ca 600 mg+ Vit D3125 U,q..d.).The bone mineral density ( BMD ) of lumbar spine( L2-4 ),the left femoral neck,greater trochanter,and Ward's triangle,serum calcium and phosphate were measured by baseline,6 months' and 12 months.Levels of serum bone-specific alkaline phosphatase( BSAP),serum secreted protein acidic and rich in cysteine (SPARC)were determined by an ELISA assay.ResultsBy 12 months,rhPTH ( 1-34 ) treatment significantly increased the lumbar spine L2-4 BMD 7.9％ (P＜0.05),serum calcium 8.3 ％ ( P＜ 0.05 ),serum BSAP 93.4％ ( P＜ 0.05 ),serum SPARC by 12.6％[ ( 195.68±59.57 vs 173.81 ±81.33 ) pμg/L,P＜0.05 ].Elcatonin therapy increased the lumbar spine L2-4 BMD by 3.2％ (P＜0.05) at the end of 12 months,but elcatonin did not influence serum calcium,BSAP and SPARC.The rhPTH( 1-34 ) increased lumbar spine L2-4 BMD more than elcatonin did at 12 months( P＜0.05 ).ConclusionrhPTH (1-34) could promote the bone anabolism more effectively than elcatonin did.Serum SPARC may play an important role in promoting osteogenesis by rhPTH.