Role of Raloxifene in Post Menopausal Osteoporosis: A Prospective study

Shanmugapriya, R (2007) Role of Raloxifene in Post Menopausal Osteoporosis: A Prospective study. Masters thesis, Madras Medical College, Chennai.


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INTRODUCTION: In 1000 BC life expectancy was only 17 years and by the time of 100 BC in the time of Julius Caesar, it had reached 25 years. In 2000 AD the average life expectancy was 79.7 years for women and 74.3 for men (Centers for Disease Control and Prevention 2004). Osteoporosis the most prevalent and a major global public health problem affecting elderly women 4 times more commonly than men. (National osteoporosis foundation 2003) Because of this demographic change the number of hip fractures increase approximately six fold increasing the morbidity in the postmenopausal group. (Cooper et al). Osteoporosis is highly prevalent in India, 4 to 6 million people are affected, it is projected that by the year 2030 the proportion of postmenopausal women will be 2nd highest next to china and the burden of osteoporosis in India will also be very high (Gupta et al). Osteoporosis is characterized by low bone mass and micro architectural deterioration of Bone tissue leading to enhanced bone fragility consequently increased risk of fractures even with little or no trauma. Post menopausal status directly attributes to osteoporosis due to hormonal deficiency and contributes to significant morbidity, mortality, reduction in quality of life, and increasing health care costs. Various drugs used are as follows: • Sex hormones, • Bisphosphonates, • Calcitonin, • Calcium and vitamin D, • Tibolone, • Teriparatide, • Flouride, • Statins, • Thiazides, • SERMS. Raloxifene is a selective estrogen receptor modulator used in the prevention and management of postmenopausal osteoporosis. To date there has been few prospective trials and several randomized control trials since 1997 comparing Raloxifene with various other standard therapies. This prospective study was undertaken to assess the efficacy of Raloxifene in the treatment of postmenopausal osteoporosis. AIM OF THE STUDY: The aim of this study was to determine the efficacy of Raloxifene in postmenopausal women by comparing the pretreatment and post treatment bone mineral density levels. SUBJECT AND METHODS: This was a prospective randomised placebo control study conducted at Govt. Kasthurba Gandhi Hospital, Chennai at the department of Obstetrics and Gynecology. This study comprised of study subject (n=50) postmenopausal women attending gynaec op for other problems from September 2004 to September 2006. The study was approved by the hospital ethical committee. The BMD studies were done at SMS Medica-Chennai osteoporosis detection centre, Nungambakkam Chennai. Inclusion Criteria: • Women who attained spontaneous menopause • The duration of menopause being minimum of two years. • Not on any drugs like hormone replacement, Vit D, Ca supplementation. • No history of any vertebral compression fractures • No history any spinal deformity or spinal surgery. • No history of osteoarthritis Exclusion Criteria: • Patients with menopausal symptoms. • Patients with history of postmenopausal bleeding • Patients on chronic medication. • Patients who had hysterectomy or premature menopause. • Patients having active rheumatoid arthritis, gastrointestinal, liver, metabolic, and Neoplastic or endocrinological disease. • History of recurrent vascular thrombosis • Family history of any breast or genital malignancies. • Hyperparathyroidism, Pagets disease, Renal osteodystrophy • History of treatment with bisphosphonates, sodiumflouride, calcitonin, estroprogestins, • anabolic steroids, cortcosteroids, Calcium or vitamin D supplementation • Smokers or alcoholics METHODS: The women so selected based on the inclusion and exclusion criteria were explained about the study and consent was obtained. Detailed menstrual, obstetric, drug intake history was taken. Each subject underwent general physical, 39 of 78 systemic abdominal examination. They were randomly assigned to the study and control groups and were subjected to DEXA scan. On the day of scan subjects were asked to eat normally. To avoid calcium supplements for at least 24 hours before the scan. They were requested to wear loose, comfortable clothing, avoiding garments that have zippers, belts or buttons made of metal and were asked to remove jewelry, eye glasses and any metal objects or clothing that might interfere with the images. Following DEXA, those assigned to the study group were given 60 mg Raloxifene orally for one year. For the randomly assigned matched control group, similarly shaped inert capsules were given for the same duration. RESULTS: This study, conducted at government Kasturba Gandhi Hospital for Women and Children, Chennai during the period September 2004 to September 2006 compares the efficacy of Raloxifene in post menopausal osteoporosis with that of a placebo. The findings from both the group of patients were correlated in terms of bone mineral density. 50 patients were included in the study and the outcomes were analyzed using various parameters. The results were subjected to statistical analysis using chisquare test, ANOVA, frequency and percentage analysis, T-test, one way tests and group correlations. Many crosstabs were formed from the results to understand various relationships in the results between the control and the placebo group. CONCLUSION: Using Raloxifene in the post menopausal group on an outpatient basis is a relatively safe and simple treatment with no major adverse effects in improving the bone mineral density in the spine and hip joint. • Raloxifene reduces the incidence of vertebral fractures and reducing the long term morbidity and mortality in postmenopausal women. • Raloxifene has no risk of endometrial changes and breast cancer, breast tenderness (compared to estrogens) and no major side effect profile. The compliance is good , • As the risk of osteoporosis increases with increasing duration of menopause, Raloxifene should be initiated as soon as menopause sets in so that the morbidity in the rapid losers can be prevented. • In a country where follow up advice is not properly complied with, e Raloxifene can be safely administered and made available in every pharmacy. So in countries like India where the resources are limited, patients must be made aware of the postmenopausal osteoporosis and treated effectively so health care costs could reduce.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Raloxifene ; Post Menopausal Osteoporosis ; Prospective study.
Subjects: MEDICAL > Obstetrics and Gynaecology
Depositing User: Subramani R
Date Deposited: 03 Dec 2017 11:04
Last Modified: 09 Dec 2017 01:52

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