6. Design of the FIT Trial Screening Visits * BMD ( < 0.68 g/cm 2 ) * Other eligibility * Vertebral X-ray Vertebral Deformity Present Vertebral Deformity Absent Vertebral Deformity Study Randomize (N=2027) 3 years Prim. Endpoint New Vertebral Deformity Sec. Endpoint All Clinical Fractures Clinical Fracture Study Randomize (N=4434) 4.25 years Prim. Endpoint Any Clinical Fracture Sec. Vertebral Deformity O STEO F OS
7. FIT Trial - Increase in BMD at Femoral Neck 4.1% increase in BMD with Alendronate p<0.001 % of patients Lancet, 348, 1996 Months alendronate placebo O STEO F OS
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9. Alendronate plus Hormone Replacement Therapy (HRT) 428 postmenopausal women receiving HRT (average duration of treatment 9.5 years) Bone mass : > 2 SD below normal Average age : 62 years Average duration of menopause : 15 years 214 women continued on HRT for one year 214 women received alendronate 10 mg/day along with HRT for one year Inpharma 26 Sept’ 1998, No. 1156: 18
10. Alendronate plus Hormone Replacement Therapy (HRT) Bone mass HRT alone group Combination therapy group (alendronate + HRT) Percentage increases in bone mass from baseline after 1 year’s treatment Inpharma 26 Sept’ 1998, No. 1156: 18 Addition of Alendronate to Hormone Replacement Therapy (HRT) results in 2 to 5 times greater increase in Bone Mineral Density (BMD) than HRT alone
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12. Alendronate in Steroid-Induced Osteoporosis (Patients receiving 7.5 mg Prednisone) Age : 17-83 year NEJM 1998; 339: 292-9. 4 2 0 -2 12 24 36 48 Lumbar Spine M e a n ( S E ) P e r c e n t C h a n g e i n B o n e M i n e r a l D e n s i t y + Week Placebo n=159 5 mg of alendronate n=161 10 mg of alendronate n=157
13. Early Postmenopausal Intervention Cohort Study (EPIC) NEJM 1998; 338(8): 485-492. 1609 postmenopausal women (aged 45 to 59 years) Study Centres : US and Europe Placebo n = 502 Alendronate 2.5 mg/day n = 499 Alendronate 5 mg/day n = 498 Estrogenprogestin n = 110
14. Hip Bone Mineral Density NEJM 1998; 338(8): 485-492. 0% 20% 40% 60% 80% 100% Placebo 2.5 mg of alendronate 5 mg of alendronate Estrogen- progestin >2% gain 2% change >2% loss Women (%)
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16. Alendronate Osteoporosis Prevention Study Group Annals of Internal Medicine, 1998; 128 : 253-261 447 women < age 40 to 59 years > Duration of menopause : 6 to 36 months before study entry Duration of trial : 3 years Placebo n = 90 Alendronate 1 mg/day n = 92 Alendronate 5 mg/day n = 88 Alendronate 10 mg/day n = 88 Alendronate 20/0 mg/day n = 89
17. Alendronate Osteoporosis Prevention Study Group (Contd.) Annals of Internal Medicine, 1998; 128 : 253-261 Mean changes from baseline in Bone Mineral Density 0 -3 -3 -2 -1 0 1 2 3 4 5 6 12 18 Month Mean change in Trochanter Bone Mineral Density, Percentage Points 24 30 36 0 -3 -2 -1 0 1 2 6 12 18 Month Mean change in Total Body Bone Mineral Density, Percentage Points 24 30 36 Placebo 1 mg/d 5 mg/d 10 mg/d 20/0 mg/d
18. Alendronate in Men with Primary Osteoporosis – Interim Results (12 months) of an Ongoing Study * BMD Inpharma 1999; No. 1196: Pg 13–14 Lumbar Spine *p<0.001 * Femoral Neck *p<0.04 *
![Osteoporosis : The Silent Thief ,[object Object],O STEO F OS Amount of bone resorbed >>> Amount of bone formed by osteoclasts by osteoblasts ¯ BONE LOSS](https://image.slidesharecdn.com/alendronate-1233838340358678-2/85/Osteoporosis-The-Silent-Thief-Osteoporosis-The-Silent-Thief-1-320.jpg)
