Osteoporosis in Men Wendy Rosenthal PharmD. This program has been brought to you by PharmCon

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1 Osteoporosis in Men Wendy Rosenthal PharmD This program has been brought to you by PharmCon

2 Osteoporosis in Men Speaker: Dr. Wendy Rosenthal, President of MedOutcomes, will be the presenter for this webcast. Wendy Munroe Rosenthal is the President of MedOutcomes, Inc. She received her Doctor of Pharmacy degree from the Medical University of South Carolina and her Bachelor of Science in Pharmacy from the University of Georgia. Speaker Disclosure: Dr. Rosenthal has no actual or potential conflicts of interest in relation to this program This program has been brought to you by PharmCon PharmCon is accredited by the accreditation counsel for Pharmacy Education as a provider of continuing pharmacy education Legal Disclaimer: The material presented here does not necessarily reflect the views of Pharmaceutical Education Consultants (PharmCon) or the companies that support educational programming. A qualified healthcare professional should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity.

3 Osteoporosis in Men Accreditation: Pharmacists: L01-P Pharmacy Technicians: L01-T Target Audience: Pharmacists & Technicians CE Credits: 1.0 Continuing Education Credit or 0.1 CEU for pharmacists/technicians Expiration Date: 8/15/2011 Program Overview: While the rate of osteoporosis in men is lower than in women, the consequences are often more devastating. However, this condition often goes unrecognized and thus untreated. Pharmacist s interventions are critical to help identify those at greatest risk and then achieve treatment goals. This program provides information on osteoporosis, its diagnosis and management in the male population. Objectives: Describe the pathophysiology of osteoporosis in men and how it differs from that in women. Discuss the risk factors of osteoporosis in the male population. Develop a therapeutic regimen for men disagnosed w ith osteoporosis. This program has been brought to you by PharmCon

4 The Numbers 2 million men have osteoporosis (8 million women) Lifetime risk for an osteoporotic fracture in men is 13% The incidence of fractures in a man is similar to that of a woman who is about 10 years younger Direct health care costs associated with osteoporosis in 2001 were $17 billion with one 1/5 or $3.4 billion for men

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6 Osteoporotic Fractures Wrist Results from trying to break a fall Warning of possible bone loss Vertebral Associated with pain and deformity and decreased quality of life The incidence of vertebral fractures in men is about ½ that of women Incidence increases 18-fold from age 45 to 85

7 Osteoporotic Fractures Hip Median age of hip fracture is 79 years Lifetime risk of hip fractures in men: 6-11% (Women: 18 20%) Primary cause of morbidity, mortality and cost About 1/3 of men die within a year after breaking a hip (26% higher than for women) 50% are discharged to a nursing home 41% return to prefracture level of function

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9 Factors Influencing Development of Osteoporosis Peak bone mass at maturity Rate of age-related bone loss during later life

10 Peak Bone Mass The highest level of bone mass achieved at skeletal maturity Attained between ages As much as 70% of peak bone mass is genetically determined

11 Age-Related Bone Loss Protracted slow phase Starts around age 35 Lose bone at a rate of 0.5-1% per year Due to osteoblastic activity and GI calcium absorption Women: Transient, accelerated phase Occurs after menopause Lose bone at a rate of 2-5% per year for 5-10 years

12 Phases of Bone Loss Normal Bone : % of peak bone mass Osteopenia : 75-90% of peak bone mass Thinning bone Microarchitecture intact Slightly higher risk of fracture Osteoporosis : <75% of peak bone mass Thinning bone Microarchitecture disrupted High risk of fracture

13 Lower Incidence of Osteoporosis in Men Higher peak bone mass & larger bones Shorter life expectancy Lack of rapid phase of bone loss

14 Who has the most risk factors for osteoporosis? Who has the greatest risk for fracture? 52 yo Male Problem list: asthma, hyperlipidemia Height / weight: 5 5, 130 lbs Family history: mother had osteoporosis 75 yo Male Problem list: HTN, smoker, hx of sexual dysfunction Height / weight: 6, 195 lbs 80 yo Male Problem list: hx of alcohol abuse, hx of vertebral fractures Height / weight: 5 7 (loss of 1.5 ), 168 lbs

15 52 yo Male Problem list: asthma, hyperlipidemia Height / weight: 5 5, 130 lbs Family history: mother had hip age 75

16 75 yo Male Problem list: HTN, smoker, hx of sexual dysfunction Height / weight: 6, 195 lbs

17 80 yo Male Problem list: hx of alcohol abuse, hx of vertebral fractures Height / weight: 5 7 (loss of 1.5 ), 168 lbs

18 Classification in Men Primary osteoporosis Age-related or idiopathic Tends to occur in men > 70 yo Secondary osteoporosis Due to hypogonadism, chronic diseases, drug therapy or adverse lifestyle practices Tends to occur in men < 70 yo

19 Secondary Causes About 2/3 of men with osteoporosis have secondary causes 15% hypogonadism 15% alcohol abuse 17% glucocorticoid excess 17% other medical conditions

20 Diagnosis & Monitoring

21 BMD Technologies X-ray based Bone absorbs x-ray photons in proportion to calcium content Measures calcium in bone Ultra-sound based Measures speed of sound through the site Assesses bone elasticity & structure Gives an estimate of BMD

22 WHO Diagnostic Categories Normal = BMD > -1.0 SD of young adult mean Osteopenia = BMD > -1 SD but < -2.5 SD below young adult mean Osteoporosis = BMD -2.5 SD or more below young adult mean

23 FRAX Tool 10 yr fracture risk model & fracture probability Based on femoral neck BMD & 9 risk factors Only for patients 40-90yo never receiving prior treatment for osteoporosis

24 FRAX Tool: Risk Factors Current age Gender Prior osteoporotic fracture Femoral neck BMD Low body mass index Rheumatoid arthritis Secondary osteoporosis Parental history of hip fracture Current smoking Alcohol intake of 3 or more drinks daily Oral glucocorticoids > 5mg/d of prednisone for > 3 mo

25 Who should be treated? Men with the following: Hip or vertebral fracture T score < femoral neck or spine after evaluation to exclude secondary causes T score -1.0 to -2.5 & 10-year probability of hip fracture >3% or 10-year probability of major osteoporosis-related fracture > 20% based on FRAX

26 Osteoporosis Prevention Plan for Men Meet recommended daily allowance for calcium and vitamin D Keep up a lifelong exercise program Don t smoke Drink in moderation Report any loss of sexual function or desire to physician

27 Physical Activity Prevent falls Weight bearing exercise maintains BMD Start early & continue throughout life Benefits site specific Benefits continue as long as the activity continues

28 Calcium Intake Recommendations No universal standard NOF: All individuals should intake at least 1200 mg of elemental calcium daily

29 Calcium Supplements Calcium carbonate is often recommended because of high % of elemental calcium and low cost Some suggest calcium citrate has greater bioavailability Calcium lactate and citrate may be preferable in the elderly and those on H 2 antagonists or proton pump inhibitors Lack of studies examining differences in therapeutic outcomes with various calcium preparations

30 Administration Issues Take citrate between meals & carbonate with meals Take with 8 oz. of liquid Do not take more than approximately 500 to 600 mg/dose Do not take with high fiber meal

31 Sources of Vitamin D Sun exposure Require about 5-15 minutes of sun exposure 2-3 times/week Diet Milk (1 cup = 100 IU); fatty fish, liver, eggs & fortified cereals

32 NOF Vitamin D Intake Recommendations Adults < 50 yo: IU daily Adults > 50 yo : IU daily

33 Remember: Adequate calcium and vitamin D supplementation are required adjunctive therapy with all medications for osteoporosis

34 Drug Therapy for Men FDA indication for use in men Alendronate (Fosamax ) Alendronate/vitamin D (Fosamax Plus D ) Risedronate (Actonel ) Teriparatide (Forteo ) Other considerations Ibandronate (Boniva ) Calcitonin (Miacalcin Fortical ) Testosterone

35 Bisphosphonates Major Action: suppress bone resorption preventing further bone loss Decrease in number or depth of resorptive sites Stops further architectural loss Slower turnover allows better mineralization Resulting increase in BMD due to more complete mineralization, not increased synthesis of bone

36 Efficacy in Men Alendronate Increased BMD at lumbar spine 7.1%, femoral neck 2.5% Significant reduction in vertebral fracture incidence, no differences in nonvertebral fractures Risedronate Increased BMD at lumbar spine 4.5%, femoral neck 1.1% Fracture data not assessed

37 Dosing Options Alendronate 10mg tab once daily 70mg tab once weekly 70mg oral solution once weekly 70mg / vit D 2800 IU once weekly 70mg / vit D 5600 IU once weekly Risedronate 35mg tab once weekly

38 Bisphosphonates Administration Issues Poor oral absorption Only 1-5% is absorbed Reduced further with the presence of food or calcium GI irritation May cause local irritation of the upper GI mucosa if not taken precisely as directed

39 Bisphosphonates Administration Requirements Take with a full glass of water in morning Do NOT eat or drink anything for at least 30 minutes after taking Do NOT lie down for at least 30 minutes after taking and until after eating Same for all oral dosage forms

40 Bisphosphonates Adverse Effects Esophageal irritation or erosion Bone, joint and/or muscle pain Hypocalcemia

41 Teriparatide Mechanism of Action Recombinant human parathyroid hormone (PTH) Identical sequence to 34 N-terminal amino acids of 84- amino acid PTH Actions of PTH: Regulation of bone metabolism Regulation of renal tubular reasorption of calcium & phosphate Regulation of intestinal calcium absorption

42 Teriparatide Efficacy in Men Increased BMD at lumbar spine 6% and femoral neck 1.5% Fracture data not assessed

43 Teriparatide Dosage and Administration 20 mcg once daily administered as subcutaneous injection into thigh or abdominal wall Take at any time of the day Supplied a pre-assembled disposable pen device with 28 doses for instructions on use Use for longer than 2yr not recommended due to lack of safety & efficacy data

44 Teriparatide Adverse Effects Dizziness Leg cramps Transient orthostatic hypotension Infrequent event seen within first several doses Begins within 4 hr of dosing and then resolves Transient increases serum calcium

45 Testosterone Consider in men with proven hypogonadism Has not been well studied Risk:Benefit unknown Risk?= increased incidence of prostatic cancer Benefit?= may increase BMD but no evidence of reduced fracture risk

46 Summary: Osteoporosis in Men Men have a lower risk for developing osteoporosis but greater risk for adverse consequences Men fracture about 10 years later than women Underlying cause must be identified First line drug treatment is generally a bisphosphonate

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