| Postmenopausal osteoporosis(PMOP) and osteoporotic fracture is acommon and frequently encountered disease in the women, as the averagelifespan of our country's population lengthening. Estrogen replacementtrerapy(ERT) has been widely used to prevent and treat PMOP, which plays asimportant role to relieve menopausal syndrome, to decrease PMOP andosteoporotic fracture, and to improve women's quatity of life. But this methodhas some adverse effects e.g. irregular vaginal bleeding, weight gain, breast pain,endometrial hyperplasia, etc. Long-term ERT will increase the risk ofhysteromyoma, breast cancer, endometrial cancer and thromboembolic disease,which limits the ERT's application for PMOP. In 1977 the 1stbisphosphonate(BP)-etidronate disodium, developed by Procter&Gamblecompany and Monsanto company, was available in Itali on market. Thissynthetic compounds can increase bone mineral density(BMD) effectively,relieve bone pain caused by osteoporosis, and reduce osteoporotic fracture without adverse effects of ERT. That made BPs become a better choice toprevent and treat PMOP.The 3rd generation BPs-risedronate sodium(RIS) has been successfullysynthesized at home and has entered phase II clinical trials. Its capsule formmay relieve adverse effect to alimentary tract further. To assess the efficacy andsafety of domestic RIS for PMOP, 240 postmenopausal women withosteoporosis or osteopenia were enrolled, and the following study wasperformed:①The general state of health, electrocardiogram, X-ray film ofthoracic vertebrae and lumbar vertebrae, BMD of L2-4 and hip, and laboratorytests, etc were examined. no statictical difference was found between two groups.②All patients were evenly randomized to receive either risedronate(5 mg/d )orplacebo for 12 months. Both groups were supplemented with element calcium500 mg and vitamin D3 200 units daily simultaneously.③At 6 and 12months(mo) the efficacy of RIS on BMD of L2-4 and hip, serum bone glaprotein(BGP), urine N-terminal telopeptides of typeⅠcollagen/creatinine(NTX/Cr), X-ray film of thoracic vertebrae and lumbarvertebrae was assessed and compared with those before treatment.④Thegeneral state of health, electrocardiogram, laboratory tests, and adverse reactionsof RIS were assessed after 3, 6, 9, 12 months of treatment, and compared withthose before treatment. According to these results, it is determined whether theRIS treatment is safe and whether the RIS should be continued or not.Result: There is no statictical difference between 2 groups in general stateof health and demographic characteristics. After treatment, 203(84.58%) patientsin line with the program, the BMD of the L2-4 and hip increased after 1 year ofrisedronate therapy,with 8.28%±13.79% gain for the lumbar vertebraecompared with 4.09%±14.60% gain of the placebo patients(P<0.05). But for the BMD of hip only 8.49%±15.58% gain was foud, and there was nodifference compared with 6.84%±18.34% gain of placebo patients(P>0.05).The serum BGP and urine NTX/Cr decreased after 1 year therapy withrisedronate,i.e., 2.94±4.73ng/ml loss for serum BGP and 9.38±65.93μg/Lloss for urine NTX/Cr. In the placebo group There were 0.53±3.90ng/ml lossfor serum BGP and 3.59±59.86μg/L gain for urine NTX/Cr with significantdifferences(P<0.05). No serious adverse events about risedronate were reported.Conclusion: RIS inhibits high bone turn over rate of PMOP patients,produces greater gains in BMD, significantly in lumbar vertebrae. It alsorelieves bone pain and reduces the risk of fracture for PMOP patients. Mainadverse reaction is mild upper gastrointestinal discomfort. There are alsodiarrhea, constipation, intraocular pressure increase, etc. The symptoms relievedas drug withdrawal. No other serious adverse reactions occur. RIS is effectiveand safe to prevent or treat PMOP only with mild adverse effects. |
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