Osteoporosis

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Slide 1 :

OSTEOFOS Osteoporosis : The Silent Thief OSTEOPOROSIS has been defined as a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of the bone tissue, with a consequent increase in bone fragility and susceptibility to fracture Amount of bone resorbed >>> Amount of bone formed by osteoclasts by osteoblasts ¯ BONE LOSS

Slide 2 :

OSTEOFOS Osteoporotic bone remodelling

Slide 3 :

OSTEOFOS Bone Remodelling With Alendronate

Slide 4 :

OSTEOFOS Mode Of Action Gets preferentially bound under osteoclasts. Osteoclasts ingest the attached alendronate. Released alendronate inactivates the osteoclasts. Bone resorption inhibited. Alendronate may reduce the number of remodelling sites

Slide 5 :

OSTEOFOS Mode Of Action (Contd.) Inhibits cytokine production by osteoblasts Supports the osteoblast mediated bone formation Induces the osteoblasts to synthesize a substance which may directly inhibit the osteoclastic resorption Alendronate inhibits the osteoclastic bone resorption without inhibiting the osteoblastic bone formation – increase in bone mass

Slide 6 :

Screening Visits * BMD (< 0.68 g/cm2) * 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 OSTEOFOS Design of the FIT Trial

Slide 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 OSTEOFOS

Slide 8 :

FIT TRIAL - Summary of Fracture Results Type of fracture % incidence P value reduction At least one new vertebral fracture 47 <0.001 Multiple (>2) new vertebral fractures 90 <0.001 Clinical (symptomatic) vertebral fracture 55 <0.001 Hip fracture 51 0.047 Wrist fracture 48 0.013 Lancet, 348, 1996 OSTEOFOS

Slide 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

Slide 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

Slide 11 :

Steroid-induced Osteoporosis Majority of bone loss occurs in the beginning (10-20%) 25% may experience a fracture 4 fold increase in all fractures Usually affects vertebrae, ribs, hip Risk higher in patients with higher dose, taking longer, low BMD etc Cause ¯ Calcium Urinary Calcium ¯ Osteoblast absorption excretion formation and function

Slide 12 :

Alendronate in Steroid-Induced Osteoporosis (Patients receiving 7.5 mg Prednisone) Age : 17-83 year NEJM 1998; 339: 292-9.

Slide 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

Slide 14 :

Hip Bone Mineral Density NEJM 1998; 338(8): 485-492.

Slide 15 :

Early Postmenopausal Intervention Cohort Study (EPIC) Results of US Cohort : Percentage increase in BMD at end of 2 years Alendronate HRT P Hip bone 1.3 + 0.3 1.8 + 0.3 P = 0.21 Lumber Spine 2.9 + 0.5 4.0 + 0.3 P = 0.06 Total body 0.8 + 0.3 1.2 + 0.2 P = 0.29 NEJM 1998; 338(8): 485-492.

Slide 16 :

Annals of Internal Medicine, 1998; 128 : 253-261 Alendronate Osteoporosis Prevention Study Group 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

Slide 17 :

Alendronate Osteoporosis Prevention Study Group (Contd.) Annals of Internal Medicine, 1998; 128 : 253-261 Mean changes from baseline in Bone Mineral Density

Slide 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 *

Slide 19 :

Dosage and Administration Dosage Prevention of postmenopausal osteoporosis 5 mg/day Treatment of postmenopausal osteoporosis 10 mg/d Administration Once-a-day with a full glass of plain water (200 ml) only, on an empty stomach Patient should not lie down for half an hour after administration Patient should not eat food for half an hour after administration

Slide 20 :

Contraindications Abnormalities of the esophagus such as stricture or achalasia Inability to stand or sit upright for at least 30 minutes Hypersensitivity to any of the components of this product Hypocalcemia OSTEOFOS

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