osteoporosis treatment

1. MIACALCIC ® Nasal Spray Training course 2004

6. Illustration of decreases in bone mass with age >10 years.

9. Illustration of the relationship between osteoporosis-associated fractures and age.

14. Medical Background Knowledge

24. Long Bone-Femur

56. The effects of osteoporosis on cortical and trabecular bone. Figure Shows the effects of osteoporosis on cortical and trabecular bone.

60. Characteristics of Primary (Postmenopausal and Senile) and Secondary steoporosis Any age Usually after age 75 10 years after menopause (often begins 55-60; can begin earlier) Age of onset chronic disorder, chronic use of certain drugs (ie. Corticosteroids) Old age, age- related Disorders Menopause, estrogen deficiency, genetic Predisposition, dietary and lifestyle factors Reasons Male/Female Male/Female Female Sex Secondary Senile Postmenopausal

65. “ hip fracture” Colles’fracture

144. The Use of SERMs in the Treatment and Prevention of Osteoporosis Oral 60-mg tablet Mode of administration Common adverse event considered to be drug related: Hot flashes (menopausal side effects) Leg cramps Precautions about use in patients with a history of thromboembolic events. Safety A selective estrogen receptor mediator Binds to estrogen receptors Reduces resorption of bone Decreases overall bone turnover Effects Prevention and treatment of postmentopausal osteoporosis Bone disease indications Raloxifene: (Evista, Eli Lilly) Available agents in United States

168. At 3 Years 200 IU Salmon Calcitonin NS Reduces New Vertebral Fractures by 37% Patients with > 1 new vertebral fracture (%) Placebo 200 IU salmon calcitonin NS  37% p=0.037 Stock et al., JBMR 1997, 12(1)

169. At 5 Years 200 IU Salmon Calcitonin NS Reduces New Vertebral Fractures by 36% in Women With 1-5 Prevalent Vertebral Fractures at Baseline Patients with > 1 new vertebral fracture (%) Placebo 200 IU salmon calcitonin NS  36% p=0.03 Chesnut et al., AJM 2000, Vol 109, 267-276

170. At 5 Years 200 IU Salmon Calcitonin NS Reduces New Vertebral Fractures by 33% All Patients (%) Placebo 200 IU salmon calcitonin NS  33% p=0.03 Chesnut et al., AJM 2000, Vol 109, 267-276

172. At 5 Years 200 IU Salmon Calcitonin NS Reduces New Vertebral Fractures by 53% in Women >70 Years Women >70 years with > 1 new vertebral fracture (%) Placebo 200 IU salmon calcitonin NS  53% p=0.012 Silverman et al., Third Amsterdam menopause symposium abstract book 2001, page 91

173. At 5 Years 200 IU Salmon Calcitonin NS Reduces New Vertebral Fractures by 62% in Women >75 Years Women >75 years with > 1 new vertebral fracture (%) Placebo 200 IU salmon calcitonin NS  62% p=0.028 Silverman et al., JBMR 2001, 16(1), S530

174. 200 IU Salmon Calcitonin NS is Effective Across All Age Groups 1,2 0 5 10 15 20 25 30 35 45 40 36%* 53%* 62%* Calcitonin Placebo Primary analysis Patients with 1-5 Vertebral fractures Post-hoc analysis All patients > 70 All patients > 75 *p<0,05 Patients (%) with vertebral fractures 1. Chesnut et al., AJM 2000, Vol 109, 267-276. 2. Silverman et al., JBMR 2001, 16(1), S530

175. Effect of Salmon Calcitonin NS* on Hip Fracture at 3 Years Placebo Salmon calcitonin NS* Patients with hip fracture (%)  72% P=0.046 Silverman et al., Third Amsterdam menopause symposium abstract book 2001, page 91 *combined 100 IU and 200 IU doses

176. Effect of Salmon Calcitonin NS* on Hip Fracture at 5 Years Placebo Salmon calcitonin NS* Patients with hip fracture (%)  68% p=0.047 Silverman et al., Third Amsterdam menopause symposium abstract book 2001, page 91 *combined 100 IU and 200 IU doses

193. MIACALCIC Nasal Spray vs Injectable 2-ml vials containing 200 IU per mL Metered-dose solution in 2ml bottles, Delivers 200 IU per spray How supplied 100IU (SC or IM) every other day (fo