The Study Of Alendronate Sodium Enteric-coated Tablets In Prevention And Treatment Of Osteoporosis In Postmenopausal Women

Objective: Postmenopausal osteoporosis(POMP), a chronic and progressive disease, is directly correlated to the lack of estrogen, as well as varied genetic factors and acquired predispositions. Its characteristic is that bone resorption exceeds to bone formation in a long term, which leads to the decrease of bone mass, the destruction of bone microstructure, the depress of bone strength, and increases the risk of bone fracture. It is severely harmful to the public health. In the recent 30 years, bisphosphonates (BPs) has developed to the most effective inhibitors of bone resorption. It is across the board of research, has certain therapeutic effect, and has widespreaded in clinical application. Alendronate, the third generation of BPs, which has a strong effect of anti-resorption of bone, can quickly degrade the bone transformational index, increase the bone mineral density, depress the risk of bone fracture, and has few of adverse reaction. Our experiment:(1) analyses the bone metabolism in postmenopausal women with relevant indicators to explore the incidence of osteoporosis, that in order to explore the direction for further treatment; (2) detects the bone mineral density, transformational index, and other serum biochemical indicator of postmenopausal women before and after the treatment of Alendronate, records the adverse reactions in the treatment period, in order to observe and analyse the efficacy and safety of Alendronate sodium enteric-coated tablets in prevention and treatment of osteoporosis in postmenopausal women, provide the foundation of the further clinical application.Methods: select 42 postmenopausal women treated in the Department of Endocrine of the Second Hospital of HeBei Medical University, aging 55~65 year-old. All of them are natural menopause more than 1 year. Their BMI is 18.1~29.4kg/m2. They are all consistent with the diagnostic criteria. (1)These 42 women are the observation group. Select 25 healthy child-bearing women, aging 25~35 year-old, to be the control group. Their BMI is 18.0~28.2kg/m2. Compare the relevant indicators of bone metabolism of the two groups: serum calcium (Ca), phosphorus (P), alkaline phosphatase (ALP), serum osteocalcin (Su-BGP), serum tartrate-resistant acid phosphatase (TRAP), bone mineral density (BMD), leptin (LP), interleukin-6 (IL-6) and so on, were statistically analyzed. All of the 42 postmenopausal women undertake a prospective, self-compared study lasting 1.5 years, take Caltrate D 600mg/d and Alendronate sodium enteric-coated tablets 70mg per week orally in 6 month, and interview per 4 weeks. Measure the BMD of lumbar vertebrae 2-4(L2-4), left neck of femur, Ward's triangle, femoral trochanter, and ALP, BGP, TRAP, ALT, AST, BUN, Crea, Ca, P before the treatment,in the end of the 6th month and 1 year after the treatment. Observe that whether or not the subjects occur adverse reaction, for example, nausea, vomitus, stomachache and other severe side effects like osteonecrosis of the jaw during the treatment in order to evaluate the therapeutic effect, safety and tolerance of oral Alendronte.Results: (1) Menopausal women compared with women of child-bearing age, serum calcium, phosphorus has no statistical difference; alkaline phosphatase, serum osteocalcin, serum tartrate-resistant acid phosphatase are statistically significant; the BMD of L2-4 and left femoral neck, femoral trochanter and Ward's triangle reduce in a statistical difference (p<0.05). No significant difference in serum leptin, interleukin-6 are statistically significant (p<0.05).(2)At the end of the 6th month of the treatment, the BMD of L2-4, left femoral neck, femoral trochanter and Ward's triangle increase 2.8%, 6.3%, 6.5%, 7.2%,which is statistically significant (P<0.05) compared with before the treatment. The BMD at the end of the 6th month compared with 1 year after the treatment has no significant difference. ALP, BGP and TRAP are significant higher before the treatment than the end of the 6th month and 1 year after the treatment (P<0.05). But there is no significant difference between the 6th month and 1 year after. The ALT, AST, BUN, Crea, Ca, P have no significant difference before and after the treatment. 3 subjects occurred nausea and stomachache, and exited the study in the end. 2 subjects were lost follow-up. All of the subjects did not have other sever side effect during the study.Conclusion: Postmenopausal women with postmenopausal osteoporosis are related to the speed up of bone metabolism, leptin levels and body fat content has no significant correlation. Alendronate sodium enteric-coated tablets for treating postmenopausal osteoporosis can significantly increase the BMD, degrade the bone transformational index, and has few side effects. It has satisfied efficacy, safety and tolerance.