ncpa ne osteoporosis for print.ppt - cecity.com file1 Osteoporosis Carrie Foust Koenigsfeld, PharmD...

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Osteoporosis

Carrie Foust Koenigsfeld, PharmD

Associate Professor

Drake College of Pharmacy

Objectives

� Define osteoporosis and identify at-risk population(s) for osteoporosis

� Discuss strategies for the community pharmacist to provide disease state education to this patient population and improve medication therapy adherence

� Discuss methods for community pharmacies to offer patient care services related to osteoporosis

� Discuss the appropriate use of the various drug products used for osteoporosis

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Impact of Osteoporosis

� ~44 million Americans aged 50 and older have osteoporosis or low bone mass

� It is estimated that by the year 2010 over 52 million Americans in this same age group will be affected

� Lifetime risk of osteoporotic fracture: 1 out of 2 women and 1 out of 5 men

� Economic consequences: ~$17 billion

What is Osteoporosis?

Condition characterized by low bone mass,

deterioration of bone, and an increase in the risk of fracture.

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Pathophysiology

� Bone remodeling unit:

– Osteoblasts (bone formation) and osteoclasts (bone resorption) in balance on bone surface

– Net bone loss occurs in O.P. due to greater bone resorption compared to formation

� Defects in mineral metabolism: calcium and vitamin D

�

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Types and Composition of Bone

� 80% adult bone is cortical bone and 20% is trabecular bone

– Cortical - forms the dense outer layer of bone

– Trabecular - spongy, latticework located primarily in the middle of bone and at the end of the long bones

� Midradius 80% Cortical 20% Trabecular

� Heel 25% Cortical 75% Trabecular

� Femur neck 75% Cortical 25% Trabecular

� Lumbar spine 40% Cortical 60% Trabecular

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National Osteoporosis Foundation. Physician’s Guide to Prevention and Treatment of Osteoporosis. Belle Mead, NJ: Excerpta Medica, Inc: 1999.


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Signs and Symptoms

� SILENT!

� Vertebral fractures: Back pain which can be chronic, disabling; kyphosis; loss of height

� Hip fracture: ~20-25% mortality within 1 year, up to 25% may require long-term nursing home care, and ~30% fully regain their pre-fracture level of independence

Educational Point

� A patient must understand their disease state and be able to recognize it.

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Diagnosis

� Gold standard: Dual energy x-ray absorptiometry (DEXA or DXA)-Hip and Spine

– Baseline and repeat q 1-3 years

� Serum and urine calcium: Ca++ balance

� 1,25-hydroxyvitamin D - osteomalacia or Vit D insufficiency

� Biochemical markers

– Urine or Blood

– Early markers of response to medication

Patient Care Service Opportunity

� Peripheral DXA

– Measures bone density of forearm, finger, or heel

� Quantitative Ultrasound Densitometry

– Assessment of risk

– Need for physician referral

– Educational opportunity

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Homework

� Identify locations that perform DEXA diagnostic assessment

T-score/Z-score

� T-score - bone mass compared with the mean peak bone mass of a normal young adult, sex adjusted reference population

� Z-score - mean BMD and SD for a healthy age-matched population are used as the reference range

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WHO Criteria

� WHO Criteria for the Diagnosis of Osteoporosis

– Normal BMD is within 1 SD of a “youngnormal” adult (T-score above –1)

– Osteopenia BMD is between 1 and 2.5 SDbelow that of a “young normal”adult (T-score between –1 and –2.5)

– Osteoporosis BMD is 2.5 SD or more below that ofa “young normal” adult (T-score at orbelow –2.5)

WHO Criteria

� Applies to:

– Postmenopausal women and men 50+yrs

� International Society for Clinical Densitometry (ISCD) recommendations for patients <50yrs:

– Use ethnic or race adjusted Z-scores instead of T-scores

– Z-scores of <-2.0 = “low bone mineral density for chronological age”

– Z-scores of >-2.0 = “within the expected range for age”

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Z-score and T-score Comparison


Indications for BMD Testing

� Women age 65+; men age 70+

� Postmenopausal women and men age 50-69 based on clinical risk factors

� Fracture after age 50

� Medical conditions (e.g., RA) or medications (e.g., glucocorticoids ≥3months)

� Assessment for osteoporosis treatment initiation/monitoring

� Discontinuation of estrogen therapy

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WHO Fracture Risk Assessment -Risk Factors

� Current age

� Gender

� Prior Osteoporotic fracture

� Femoral neck BMD

� Low body mass index

� Oral Glucocorticoids ≥3months (ever)

� Rheumatoid arthritis

� Parental history of hip fracture

� Current smoking

� Alcohol intake (3 or more drinks/d)

� Secondary Osteoporosis

Conditions Associated with Osteoporosis/Fracture

– Hyperthyroidism

– Diabetes

– Rheumatoid arthritis

– Hyperparathyroidism

– Multiple myeloma

– Premature ovarian failure/prolonged amenorrhea

– Menopause (≤45 y/o)

– Inflammatory bowel disease/Malabsorption

– And many, many more…

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Medications Associated with Osteoporosis/Fracture

– Corticosteroids

� ↓intestinal absorption

� ↑urinary excretion

� Inhibit osteoblasts

– Loop diuretics (vs Thiazides ↓calcium excretion)

� ↑calcium excretion

– Excess thyroid hormone

� ↑osteoclast activity

– Anticonvulsants

� ↓calcium absorption by ↑ catabolism of vitamin D

Medications Associated with Osteoporosis/Fracture

– Aluminum containing antacids� ↓calcium absorption

– Tetracycline� ↓calcium absorption

– Long term Heparin � ↓vitamin D

– Sedatives� ↑fall risk

– Depo-Provera (November 2004)� ↓ estradiol levels, leading to increased bone

resorption

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Treatment Recommendations

Postmenopausal women and men age 50+ with the following:

� Hip or vertebral fracture

� T-score ≤-2.5 at femoral neck or spine

� Low bone mass (T-score -1 to -2.5) at femoral neck or spine and either:

1) 10 yr probability of hip fracture ≥3% based on FRAX

2) 10 yr probability of a major osteoporosis related fracture ≥20% based on FRAX

WHO FRAX Algorithm

� 10-year hip fracture risk� 10-year probability of a major osteoporotic fracture� Developed to evaluate fracture risk of patients with

osteopenia� Based on bone mineral density at the femoral neck

and clinical risk factors� Only applicable for:

– Patients 40-90yrs– No prior osteoporosis treatment– Femoral neck data or total hip BMD (women only)

� http://www.shef.ac.uk/FRAX/

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FRAX Algorithm

� Online

� Paper Charts

– Men and Women >50 yrs; increments of 5 yrs

– China, France, Italy, Japan, Spain, Sweden, Turkey, UK, and USA

– Select according to BMI or T-score for femoral neck BMD

– Will need number of clinical risk factors

– 10 yr prob. of hip facture or major osteoporotic fracture

Educational Point

� Patients need to understand their test results to improve medication therapy adherence.

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� National Osteoporosis Month in May

– Online or Paper FRAX for all patients

– Show change of risk with decreased risk factors

� Focus on modifiable risk factors

– Referral for diagnostic testing and assessment

Prevention & Treatment Options

� Lifestyle Modifications� Prevention:

– HRT

� Prevention and treatment:– Calcium & vitamin D– Bisphosphonates (Exception: Reclast- treatment

only)– SERMs: Raloxifene

� Treatment only:– Calcitonin– Forteo

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Lifestyle Modifications

� Weight bearing exercise

� Smoking cessation

� Alcohol in moderation

� Caffeine

� Fall prevention

HRT-Prevention Only

� Mechanism for improvement of BMD -

↓ osteoclast activity, ↑intestinal calcium absorption

� 50-80% decrease in vertebral fractures and 25% decrease in non-vertebral fractures within 5 years

� WHI:

– 34% reduction in hip fracture

– 24% reduction in total fractures

� Do we still recommend HRT for Osteoporosis???

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Menostar (Estradiol Transdermal)

� Indication - prevention of postmenopausal Osteoporosis

� 14mcg/day x 7 days

� Intact uterus - progestin administered x 14 days Q6-12 months; endometrial biopsy yearly or as recommended

� Drug interactions and contraindications similar to other estrogen products

Calcium and Vitamin D -Prevention and Treatment

� Calcium Requirements

– 9-18 years 1,300mg/d

– 19-50 years 1,000mg/d

– 51-70 years 1,200mg/d

– >70 years 1,200mg/d

� Vitamin D Requirements

– 9-50 years 200IU/d

– 51-70 years 400IU/d

– >70 years 600IU/d

NEW 2008 NOF recommendation

– 50+ years 800-1000IU/d

Bone Health and Osteoporosis - A Report of the Surgeon General 2004; 7:159-160.Source: Food and Nutrition Board of the Institute of Medicine 1997.

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Calcium -Prevention and Treatment

� Calcium Sources

– Dietary

– Supplement - most commonly used– Calcium carbonate

– Calcium citrate

– Coral Calcium????

� Elemental content

� Absorption

– ≤600mg at a time

– Gastric acid secretion

� Side effects

Estimating Daily Dietary Calcium Intake

� Step 1: Estimate calcium intake from calcium-rich foods

Product Servings/d Est.Calcium

/serving (mg)

Calcium (mg)

Milk (8oz) X 300 =

Yogurt (6oz) X 300 =

Cheese (1 oz. or 1 cubic in.)

X 200 =

Fortified foods/ juices

X 80-1,000 =

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Estimating Daily Dietary Calcium Intake

� Step 2: Total from Step 1 + 250 mg for nondairy sources = Total Dietary Calcium (mg)

� Nondairy sources:

– Cereals (40-50IU/serving)

– Egg yolks

– Salt-water fish

– Liver

Educational Point

� Send patients away with specific examples of calcium sources and amounts

– Brochures available regarding lifestyle modification

� National Osteoporosis Foundation

� Calcium Calculator: www.calciuminfo.com

� NIH Osteoporosis and Related Bone Disease-National Resource Center

–http://www.niams.nih.gov/Health_Info/Bone/default.asp

� Pharmaceutical Companies

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� Grocery store tour to review food labels and identify calcium rich foods

� Collaborate with a Registered Dietician; offer appointments one day/month for basic nutrition education

– Individual

– Group classes

Patient Case

� A 70-year-old ambulatory patient has recently been started on Prednisone 60mg daily for her polymyalgia rheumatica (PMR). On reviewing her prescription, you discuss her calcium intake and she states “I’m taking one or two Tums a day”

– What are the issues here?

– What would you suggest?

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Vitamin D

� Primary Vitamin D Sources - Supplement or Sun

� <10% dietary calcium absorbed if deficient

� 1,25-hydroxyvitamin D levels

� Osteoporosis

� Celiac or inflammatory bowel disease

� Anticonvulsants

� Elderly homebound

� Renal disease

� Persistent musculoskeletal pain

Vitamin D

� <20ng/mL deficient; normal 30-60ng/mL

� Tx with 25,000 - 50,000IU vitamin D2 (ergocalciferol - RX only) dose orally once a week for 6-8 weeks; recheck in 2 months; maintenance may require a dose every 2-4 weeks

� May also do 1,000IU QD vitamin D3 (cholecalciferol - OTC)

� If advanced renal disease (CrCl <30ml/min), recommend calcitriol (active form - RX only) 0.25mcg/day

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Educational Point

� Patients often do not understand “why” vitamin D is important

� Readily identifiable target groups

– A patient purchasing calcium

– Prescription drug category

– Recent fracture


� Risk Factor Questionnaire

� Counseling on modifiable risk factors

� OTC counseling

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Bisphosphonates -Prevention and Treatment

� Impair osteoclast function and decrease the number of osteoclasts

� Retained by the skeleton for an extended period of time - long term effects


� Alendronate (Fosamax)

– Also approved for treatment of men; treatment of men/women with glucocorticoid induced osteoporosis

– Vertebral and hip fractures ↓50% over 3 years

– Generic now available

– 5mg/d or 35mg/wk for prevention; 10mg/d or 70mg/wk for treatment

– Liquid formulation

– Fosamax Plus D (2800IU Vit D/wk or 5600IU VitD/wk)

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� Risedronate (Actonel)

– Also approved for treatment of men; prevention/treatment of men/women with glucocorticoid induced osteoporosis

– Vertebral fractures ↓41-49% (significant ↓ in vertebral fractures after 1 year); non-vertebral fractures ↓36% over 3 years

– 5mg/d, 35mg/wk, 150mg/month

– Actonel + Calcium (35mg/wk + 6 tabs 500mg Calcium Carbonate)


� Ibandronate (Boniva)

– Vertebral fractures ↓ 50% over 3 years

– 2.5mg/d or 150mg/month for prevention/treatment

– 3mg/3ml IV administered over 15-30seconds Q3mo (treatment only)

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Educational Points

� Bisphosphonate Counseling:

– Esophageal side effects

� Full glass of water

� Remain upright, do not take any medications, eat or drink (except water) for ½ hour after (60 minutes with Boniva)

� Recent Class effect - osteonecrosis of the jaw

� Avoid in patients with severe renal dysfunction

Bisphosphonates -A Few Years or Forever?

� FLEX Trial (Fracture Intervention Trial Long Term Extension)

– Randomized, DB, 10 US Centers

– 1099 postmenopausal women with a mean of 5yrs prior alendronate treatment

– 5mg/d or 10mg/d or placebo for 5 years

– Primary Outcome Measure - Total hip BMD

JAMA 2006; 296:2927-2938.

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FLEX Trial Results

� Placebo

– total hip BMD decline -2.4%; spine -3.7%

– Mean remained at or above baseline

� NS risk of nonvertebral fractures btw two groups

� Lower risk clinical vertebral fractures

– 5.3% placebo and 2.4% alendronate

(RR 0.45 95% CI 0.24-0.85)

� Conclusion - D/C for up to 5 yrs does not appear to significantly increase fracture risk; women at high risk of clinical vertebral fracture may benefit from continuation

Reclast (Zoledronic Acid) -Treatment Only

� Bisphosphonate

� Vertebral fracture ↓70% (with significant ↓ after 1 year); hip fracture ↓41%; non-vertebral ↓25%

� 5mg/year - 15 minute infusion� Concurrent Calcium+D recommended� General Cautions - hydration� Question of Atrial Fibrillation

� FDA approved for reducing complications of solid tumor bone metastases

– Recent study regarding breast cancer - helps prevent spread to bone and breast recurrence

� Cost $1300/yr

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Horizon Trial

� 3,889 postmenopausal osteoporosis pts

� Randomized to zoledronic acid 5mg/placebo

� All received calcium/vit D

� TX group/placebo– Vertebral fracture 3.3% vs 10.9% (RR 0.3, 95%

CI 0.24-0.38)

– Hip fracture 1.4% vs 2.5% (HR 0.59, 95% CI 0.42-0.83)

N Engl J Med 2007; 356:1809-22.

Horizon Recurrent Fracture Trial

� Randomized, double-blind, placebo controlled study

� 2,127 patients age 50+; hip fracture with surgical repair within the past 90 days

� Primary endpoint - new clinical fracture

� Tx group/placebo rate of new fractures– 8.6% vs 13.9% (HR 0.65, 95% CI 0.5-0.84,

p=0.001)

� Death: 9.6% tx vs 13.3% placebo died (HR 0.72, 95% CI 0.56-0.93, p=0.01)

N Engl J Med 2007; 357.

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Homework

� Identify locations that offer Boniva injections or Reclast infusion

Selective Estrogen Receptor Modulators (SERMS) - Prevention and Treatment

� Raloxifene (Evista)

– Estrogen-like effects in some tissues (+ bone)

– Estrogen blocking effects in others (reduced risk for breast and uterine cancer)

– 30-55% reduction in risk of vertebral fractures

– 60mg/d with or without food

– May increase hot flashes (6%); thromboembolic risk

– Recent indication update

� Reduction in the risk of invasive breast cancer…

– STAR Trial - Tamoxifen and Raloxifene

JAMA 2006; 295:2727-2741.

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� Breast Cancer Awareness month is October

� Handouts available

� If patient has family history, educate on benefit of SERM therapy in those who qualify

Calcitonin-Salmon (Miacalcin) -Treatment

� Suppresses bone resorption by inhibiting osteoclast activity

� ~35% reduction new vertebral fractures

� Approved for women >5 years postmenopausal with low bone mass

� Dual action - ↓ incidence of fracture and analgesic effect

� Available as a nasal spray and subcutaneous

� Single nasal spray dose 200IU/d

� Adverse effects: congestion, nasal discharge, sneezing

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Forteo (Teriparatide) - Treatment

� Recombinant Human Parathyroid hormone

– Only agent currently available that stimulates osteoblastic activity

� Indicated for treatment of men and postmenopausal women with osteoporosis with high risk of fracture

� Vertebral fracture ↓65%; nonvertebral fracture ↓53%


� 3ml pre-filled pen containing 750mcg

� Use for up to 28 days

� Refrigerate

� Dose - 20mcg QD SC injection into thigh or AB

� Mild adverse effects: nausea, dizziness, leg cramps

� Cost concerns

� Combination with a Bisphosphonate?

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� Black Box Warning - Do not use in patients with high risk for or who have osteosarcoma

� Patients with underlying hypercalcemic disorders should not receive Forteo

� Pregnancy Category C

Forteo Connect

� Insurance investigation

– Lowest out-of-pocket cost

– Complete prior authorization

– Patient assistance eligibility

� One-on-one support

– Injection training

– Provide information and answer questions

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Patient Case

� A 65-year-old patient who has been taking Fosamax has a sudden stroke and is admitted to the hospital. She has bilateral paralysis and remains in bed most of the day.

– What are your concerns if the Fosamax is continued?

– What is your recommendation?

Pre-/Post Learning Case

� HPI: BT is a 55 yo Caucasian female who presents to the internal medicine clinic you work in for a DEXA scan. She recently participated in an osteoporosis screening at a local community pharmacy that indicated increased risk and need for further assessment.

� PMH: Asthma & GERD (both controlled with current drug therapy); Hx of prednisone 5mg QD for asthma exacerbation - two 3-4 month courses of therapy over past two years; post-menopausal-symptom free (recently discontinued Prempro use x 3 years).

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� FH: Father died of an MI at age 70. Mother age 79 has osteoporosis with history of hip fracture 6 months ago.

� SH: Married, two children. Lactose intolerant. Does not drink alcohol. Non-smoker.

� Allergies: NKDA

� Medications:

Advair 250/50mcg 1 inhalation BIDAlbulterol HFA 1-2 puffs Q4-6 h PRNProtonix 40mg QD


PE:� BP: 120/80 mmHg� Wt: 145 Ht: 5’5’’Labs (performed today): � SrCr 1.0mg/dl DEXA t-score: -2.7 femoral

neck -2.5 spine� 1,25-Hydroxyvitamin D 10ng/ml� Calcium 6.7mg/dl� Albumin 4.0g/dl

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Pre-/Post Learning Case Questions

� 1) Which of the following risk factors for osteoporosis does the case patient have?

� A. Glucocorticoid use

� B. Weight

� C. GERD


� 1) Which of the following risk factors for osteoporosis does the case patient have?

� A. Glucocorticoid use

� B. Weight

� C. GERD

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� 2) Based on the WHO criteria for diagnosis of osteoporosis, the patient’s T-score at both the femoral neck and spine indicates:

� A. Normal bone mineral density

� B. Osteopenia

� C. Osteoporosis


� 2) Based on the WHO criteria for diagnosis of osteoporosis, the patient’s T-score at both the femoral neck and spine indicates:

� A. Normal bone mineral density

� B. Osteopenia

�C. Osteoporosis

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� 3) Based on patient specific characteristics, the patient meets the criteria for BMD testing.

� A. True

� B. False


� 3) Based on patient specific characteristics, the patient meets the criteria for BMD testing.

�A. True

� B. False

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� 4) Which of the following is the bestoption for treatment of the case patient’s vitamin D deficiency?

� A. 25,000 IU vitamin D2 weekly

� B. 200 IU vitamin D3 daily

� C. 0.25mcg calcitriol daily


� 4) Which of the following is the bestoption for treatment of the case patient’s vitamin D deficiency?

� A. 25,000 IU vitamin D2 weekly

� B. 200 IU vitamin D3 daily

� C. 0.25mcg calcitriol daily

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� 5) Which of the following is the most appropriate next step in therapy for this patient?

� A. Hormone Replacement Therapy

� B. Bisphosphonate

� C. Forteo


� 5) Which of the following is the most appropriate next step in therapy for this patient?

� A. Hormone Replacement Therapy

� B. Bisphosphonate

� C. Forteo

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Summary - Steps for Osteoporosis

Management

� Assess risk factors:

– modifiable and non-modifiable

� Assess T-score, Z-score

� Lifestyle modifications

� Calcium intake

� Drug therapy recommendations

� Continued follow-up

Q & A

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Thank You

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