GUIDELINE NOTES FOR OSTEOPOROSIS SCREENING

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1 GUIDELINE NOTES FOR OSTEOPOROSIS SCREENING Last updated and approved by Trillium CHP s Quality Management Improvement Committee on March 20, 2013 Originally developed in May 2003 by the LIPA Osteoporosis Screening Consensus Committee, a workgroup appointed by the LIPA Managed Care Committee. Committee members were: Jon Ekstrom, MD, Chair; Doug Austin, MD; John Bagdade, MD; Cathyrn Chicola, MD; Robert Gunderman, MD; Paul Longstreth, MD; Jane Mossberg, MD; Byron Musa, MD Lipa was renamed Trillium Medicaid on September 1, Literature reviews and recommendations of other organizations: The prevalence, clinical consequences, and economic impact of osteoporosis are summarized in extensive literature reviews and are not duplicated here. Please see: The National Osteoporosis Foundation NOF s Newly Revised 2013 Clinician s Guide to Prevention and Treatment of Osteoporosis at (Accessed 3/6/2013) US-Adapted WHO Fracture Risk Assessment Tool. This is a tool from the World Health Organization (WHO) that assesses 10 year fracture risk. NOF recommends use of this tool for osteoporosis screening and treatment. US Preventive Services Task Force (USPSTF), Screening for Osteoporosis in Postmenopausal Women (updated 2011), US Preventive Services Task Force (USPSTF), Vitamin D and Calcium Supplementation to Prevent Fractures (2013), The American Association of Clinical Endocrinologists has posted their Medical Guidelines for Clinical Practice for the Diagnosis and Treatment of Postmenopausal Osteoporosis at (Accessed 3/7/2013) Gourlay ML, Fine JP, Preisser JS, et al. Bone-Density Testng Interval and Transition to Osteoporosis in Older Women. N Engl J Med 2012; 366: Magnitude of Issue (from NOF) Osteoporosis is a silent disease until it is complicated by fractures fractures that can occur following minimal trauma. These fractures are common and place an enormous medical and personal burden on individuals during aging and a major economic toll on the nation. Osteoporosis can be prevented, diagnosed and treated before any fracture occurs. Importantly, even after the first fracture has occurred, there are effective treatments to decrease the risk of further fractures. Prevention, detection and treatment of osteoporosis should be a mandate of primary care providers.

2 Guideline Notes for Osteoporosis Screening Decision Sequence, March 2013 Page 2 Defining Osteoporosis The diagnosis of osteoporosis is established by measurement of bone mineral density (BMD) or by the occurrence of adulthood hip or vertebral fracture in the absence of major trauma (such as a motor vehicle accident or multiple level falls). WHO Definition of Osteoporosis Based on BMD Classification T-score Normal T-score -1.0 Low Bone Mass (Osteopenia) -1.0 > T-score > -2.5 Osteoporosis T-score -2.5 Severe or Established Osteoporosis T-score < -2.5 with one or more fractures Recommendations For concise presentation, recommendations for BMD screening/testing and Vertebral Imaging are outlined in an attached decision sequence flow sheets. The numbers of the following paragraphs serve as references to those flow sheets. Indications for BMD Testing and Screening: 1. Female 65 years OR Male 70 years? NOF guidelines recommend that women 65 years and men 70 years should receive BMD testing for osteoporosis. Women and men who have already been tested and are undergoing treatment for osteoporosis should continue with medically appropriate care. 2. Suffered a fracture at age 50 years? Adults age 50 and older with non-traumatic vertebral compression fractures or extremity fractures from minimal trauma (in the absence of metastatic disease or other local mechanical problem) are presumed to have osteoporosis. The NOF guidelines recommend BMD testing for these adults to determine degree of disease severity. 3. Bone Disease? When considering BMD screening for osteoporosis, taking a history and evaluating risk factors is important. Many conditions that affect the bones will be obvious from history or from routine laboratory tests obtained as part of previous health care. 4. Test and treat disease If a patient is already known to have one of the conditions found in Table 1, BMD screening does not apply. The underlying condition should be evaluated and treated. These conditions have higher than average risk for decreased bone density. Depending on the condition and circumstances, BMD testing with central densitometry may be helpful to guide therapy. To expedite referral approval, requests for referrals for bone evaluation for patients with these conditions should indicate the diagnosis on the request form. Such requests should not be evaluated as screening test requests.

3 Guideline Notes for Osteoporosis Screening Decision Sequence, March 2013 Page 3 Table 1. Disorders Known to Contribute to Osteoporosis and Fractures Osteoporosis Osteoporosis includes patients with osteoporosis diagnosed by previous densitometry or bone biopsy Osteoporosis includes a presumptive diagnosis for patients age 50 and older with nontraumatic vertebral compression fractures or extremity fractures from minimal trauma (in the absence of metastatic disease or other local mechanical problem). Osteoporosis also includes a presumptive diagnosis for women age 65 and older and men age 70 and older. Note: Bone appearance (whiteness or darkness on x-ray is not a reliable indicator of density Gastrointestinal Disease Celiac Disease Crohn s disease Gastrectomy or Gastric Bypass GI Surgery Inflammatory Bowel Disease Malabsorption Pancreatic Disease Primary Biliary Cirrhosis Short Bowel Syndrome Genetic Disorders Cystic Fibrosis Ehlers-Danlos Gaucher s Disease Glycogen Storage Disease Hemochromatosis Homocystinuria Idiopathic Hypercalciuria Marfan Syndrome Menkes Steely Hair Syndrome Osteogenesis Imperfecta Parental history of hip fracture Porphyria Riley-Day Syndrome Endocrine and Metabolic Disorders Acromegaly Adrenal Insufficiency Central Adiposity Cushing s Syndrome Diabetes Mellitus Type I & II Growth Hormone Deficiency Hypogonadism Hypophosphatasia Hypercortisolism Hypercalciuria Hyperparathyroidism Hyperprolactinemia Hyperthyroidism Idiopathic Hypercalciuria Porphyria Pregnancy Thyrotoxicosis Hypergonadal States Androgen Insensitivity Anorexia Nervosa and Bulemia Athletic Amenorrhea Hyperprolactinemia Panhypopituitarism Premature Menopause Premature Ovarian Failure Turner s and Klinefelter s Syndrome Rheumatic and Autoimmune Diseases Ankylosing Spondylitis Lupus Rheumatoid Arthritis Other Rheumatic and Autoimmune Disorders Hematologic Disorders Hemophilia Leukemia and Lymphoma Monoclonal Gammopathies Multiple Myeloma Sickle Cell Disease Systemic Mastocytosis Thalasemmia

4 Guideline Notes for Osteoporosis Screening Decision Sequence, March 2013 Page 4 Central Nervous Disorders Epilepsy Multiple Sclerosis Parkinson s Disease Spinal Cord Injury Stroke Other Disorders AIDS/HIV Alcoholism Amyloidosis COPD Chronic Metabolic Acidosis Congestive Heart Failure Depression Emphysema End Stage Renal Disease Excess Vitamin A Idiopathic Scoliosis Immobilization Major Depression Metastatic Cancer with Pathologic Fracture Muscular Dystrophy Nutritional Deficiencies (Calcium, Vit. D, &Protein) Organ Transplantation Paraplegia, Quadriplegia Parenteral Nutrition Post-transplant Bone Disease Prior Fracture as an Adult Renal insufficiency/failure Sarcoidosis Weight Loss Medications Aluminum (in antacids) Androgen deprivation therapy Anticoagulants (heparin) Anticonvulsants Aromatase inhibitors Barbituates Cancer chemotherapeutic drugs (may lead to remodeling which may lead to osteoporosis) Cyclosporine A and Tacrolimus Depo-medroxyprgesterone (premenopausal contraception) GnRH analogs Heparin Immunosupressive agents (such as used in transplant patients) Lithium Methotrexate Protein Pump Inhibitors Selective Serotonin Reuptake Inhibitors Systemic steroid therapy ( 5 mg/d of prednisone for 3 months) Tamoxifen (premenopausal use) Thiazolidinedioones (such as Actos and Avandia) Thyroid hormone (if higher then replacement amount) Warfarin 5. Postmenopausal Women < age 65 or Men age 50 to 69 who have a risk factor profile with a ten year probability of major osteoporotic fracture 10% or hip fracture of 1.5%. Because menopause reduces endogenous estrogen and may increase need for medical intervention in high risk patients, all women should have evaluation for risk factors for osteoporosis around the time of menopause. Men should have evaluation for risk factors beginning at age 50 years old. NOF guidelines recommend BMD screening for younger postmenopausal women and men age 50 to 69 based on risk factor profile. If based on WHO Fracture Risk Assessment Tool (FRAX) their ten year probability of major osteoporotic fracture is 10% or probability of a hip fracture is 1.5% there is concern for osteoporosis based on their clinical risk factor profile and BMD screening is recommended. 6. No evidence to support BMD screening in premenopausal women or men < 50 years old. Follow status. BMD measurement is not recommended in children or adolescents and is not routinely indicated in healthy young men or premenopausal women unless there are specific risk factors for bone loss. Women and men not meeting criteria for screening or testing who are concerned about bone density can be offered advice about ways to reduce fracture risk through diet, exercise, and safety precautions (see Non-medication advice).

5 Guideline Notes for Osteoporosis Screening Decision Sequence, March 2013 Page 5 7. Will abnormal densitometry change therapy? The purpose of BMD screening and testing is to guide therapy. The National Osteoporosis Foundation algorithm for evaluating osteoporotic risk fracture recommends that BMD screening is not indicated unless the results will influence the patient s treatment decision. If the patient will refuse medication, do not perform densitometry unless there is some expectation that an abnormal measurement will cause the patient to change that decision or cause the patient to more rigorously follow non-medication treatment advice. It would be reasonable to re-address the issue of potential osteoporosis screening and treatment options at subsequent periodic health exams. The National Osteoporosis Foundation algorithm for evaluating osteoporotic fracture risk recommends that at risk individuals who are not willing to consider medication treatment be given advice about ways to reduce fracture risk through diet, exercise, and safety precautions (see Non-medication advice). 8. Central test abnormal? Dual energy x-ray absorptiometry (DXA) measurement of the hip and spine is the technology now used to establish or confirm a diagnosis of osteoporosis, predict future fracture risk and monitor patients by performing serial assessments. Quantitative computerized tomography may be useful in cases when DXA is precluded by metallic hardware or localized bony abnormalities. However, the literature and several experts indicate that QCT tends to over-diagnose osteoporosis, is less useful than alternative methods, and is not appropriate for routine screening. Consider discussing choice of technique with a knowledgeable bone densitometrist when in doubt. 9. If the central test is normal, individualize non-medication advice. Consider re-screening in 15 years. The central tests are the current gold standard. If normal, no further BMD testing is indicated in the absence of significant changes in clinical status, and treatment for osteoporosis would not be started. These adults should still be offered advice about ways to reduce fracture risk through diet, exercise, and safety precautions (see Non-Medication advice). The recommendation to consider BMD screening again in fifteen years is based on Recent Findings from Study of Osteoporotic Fractures (funded by NIH) specifically addressing testing intervals in older woman to identify osteoporosis before a major fracture occurred. 10. If the central test is abnormal, individualize non-medication advice and consider pharmacological therapy. All adults with an abnormal test and/or hip or vertebral (clinical or asymptomatic) fracture(s) should be advised on reducing fracture risk through diet, exercise, and safety precautions and considered for pharmacologic therapy. Postmenopausal women and men age 50 and older presenting with the following should be considered for pharmacological treatment: T-score at the femoral neck or spine after appropriate evaluation to exclude secondary causes. Low bone mass (T-score between -1.0 and -2.5 at the femoral neck or spine and a 10-year probability of a hip fracture 3% or a 10-year probability of a major osteoporosis-related fracture 20 % based on the US-adapted WHO algorithm. FDA prescription drugs approved for postmenopausal osteoporosis in alphabetical order are bisphosphonates (alendronate, ibandronate, risedronate, and zoledronic acid), calcitonin, estrogen agonist/antagonist (raloxifene), estrogens and/or hormone therapy, parathyroid hormone (Teripartide) and RANKL inhibitor (denosumab). FDA prescription drugs approved for men in alphabetical order are bisphosphonates (alendronate, risendronate, and zoledronic acid) and parathyroid hormone (teriparatide); also Denosumab for men receiving ADT for prostate cancer. The NOF recommends that individual clinical judgment should be exercised when making treatment decisions. No pharmacologic therapy should be considered indefinite in duration. After the initial three to five year treatment period, a comprehensive risk assessment should be

6 Guideline Notes for Osteoporosis Screening Decision Sequence, March 2013 Page 6 performed. There is no uniform recommendation that applies to all patients and duration decisions need to be individualized. Estrogen has been extensively documented as effective for postmenopausal women for prevention and treatment of osteoporosis (50% decrease in vertebral fractures and 25% decrease in nonvertebral fractures with 5 years of use). Consequently, the first-line medication for women use to be estrogen in the absence of contraindication. However, since this guideline was first issued, the Food and Drug Administration (FDA) issued a statement advising women and health care professionals about important safety changes to labeling of all estrogen and estrogen with progestin products for use by postmenopausal women. Prior to initiating prescription medicine, all secondary causes of osteoporosis should be evaluated and treated appropriately (see #3 above). As many as 50-80% of men with osteoporosis have a secondary cause of osteoporosis. Up to 25% of post-menopausal women with osteoporosis may have osteoporosis due to a secondary cause. All treatment decisions require clinical judgment and consideration of individual patient factors, including patient preferences, comorbidities, risk factors not captured in the FRAX model (e.g., frailty, falls), recent decline in bone density and other sources of possible under- or overestimation of fracture risk by FRAX. The therapeutic thresholds do not preclude clinicians or patients from considering intervention strategies for those who do not have osteoporosis by BMD (WHO diagnostic criterion of T-score 2.5), do not meet the cut points after FRAX, or are not at high enough risk of fracture despite low BMD. Conversely, these recommendations should not mandate treatment, particularly in patients with osteopenia. Decisions to treat must still be made on a case-by-case basis. A 2002 report (Yield of laboratory testing to identify secondary contributors to osteoporosis in otherwise healthy women, Tannenbaum C, et. Al., Journal of Clinical Endocrinology & Metabolism, vol. 87 no. 10, , 2002) compared the cost per case for detecting such conditions using various diagnostic strategies. A recommended strategy was to test such women using serum calcium, serum parathyroid hormone and 24 hour urine calcium routinely and add serum TSH for all women on thyroid replacement (to detect subclinical overtreatment). Such testing may be especially considered if the degree of osteoporosis is unexpectedly severe for the age, race, gender, and hormonal status of the individual. 11. Follow for compliance. To achieve the goal of avoiding fractures and their associated morbidity and mortality, patients need to comply with medication therapy and comply with non-medication interventions over many years. Maintaining compliance over time usually requires regular follow-up visits and encouragement. 12. Subsequent BMD testing is not screening. Findings from Study of Osteoporotic Fractures (funded by NIH) recommend that if the central test is abnormal and medication is not initiated, screening for older woman be repeated in: 15 years for osteopenia with with -1.0 > T score> -1.5; 5 years for osteopenia with -1.5 T score> -2.0; and 1 year for T score NOF guidelines recommend that BMD should be monitored one to two years after initiating pharmacological therapy and at two-year intervals thereafter. Indications for Vertebral Imaging: A vertebral fracture is consistent with a diagnosis of osteoporosis, even in the absence of a bone density diagnosis, and is an indication for pharmacologic treatment with osteoporosis medication to reduce fracture risk. Proactive vertebral imaging is the only way to diagnose these fractures.

7 Guideline Notes for Osteoporosis Screening Decision Sequence, March 2013 Page 7 Radiographically confirmed vertebral fractures are a sign of impaired bone quality and strength and is a strong predictor of new vertebral and other fractures. The presence of a single vertebral fracture increases the risk of subsequent fractures 5-fold and the risk of hip and other fractures 2- to 3-fold. Vertebral imaging can be performed using a lateral thoracic and lumbar spine x-ray or by lateral vertebral fracture assessment, available on most modern DXA machines. Because vertebral fractures are so prevalent in older individuals and most produce no acute symptoms, vertebral imaging tests are recommended for the following individuals: I Indications for Vertebral Imaging Women 70 and Men 80 All Women 65 and Men 70 T-score Postmenopausal Women and Men 50 Postmenopausal Women and Men Low trauma fracture Historical or prospective height loss 1.5 OR recent or on-going long-term glucocorticoid treatment. Once a first vertebral imaging test is done, it need only be repeated if prospective height loss is documented or new back pain or postural change occurs. Non-medication advice To achieve the goal of avoiding fractures and their associated morbidity and mortality, factors other than medication need to be addressed. Counseling should be provided on the risk of osteoporosis and related fractures. Advise all individuals to obtain an adequate intake of dietary calcium. Lifelong adequate calcium intake is necessary for the acquisition of peak bone mass and subsequent maintenance of bone health. The NOF supports the Institute of Medicine (IOM) recommendations that men age consume 1,000 mg per day of calcium and that women age 51 and older and men age 71 and older consume 1,200 mg per day of calcium. There is no evidence that calcium intake in excess of these amounts confers additional bone strength. Adequate calcium intake can slow the rate of bone loss. Inadequate intake or inadequate absorption worsens bone loss. Patients on proton pump inhibitor therapy may be at risk for low calcium absorption because of low stomach acid. Per USPSTF recommendation statement in 2013, there is inadequate evidence to recommend calcium supplementation for primary prevention of fractures in community-dwelling individuals. Adequate vitamin D intake is important for bone health. Vitamin D plays a major role in calcium absorption, bone health, muscle performance, balance and risk of falling. NOF recommends an intake of 800 to 1,000 international units (IU) of vitamin D per day for adults age 50 and older. Institute of Medicine Dietary Reference Intakes for vitamin D are 600 IU per day until age 70 and 800 IU per day for adults age 71 years and older. Per USPSTF recommendation statement in 2013, current evidence is insufficient to recommend vitamin D supplementation for the primary prevention of fractures in community-dwelling adults. However, vitamin D supplementation is effective in preventing falls in community-dwelling adults aged 65 years or older who are at increased risk for falls. Recommend regular weight bearing and muscle strengthening exercise to reduce the risk of falls and fractures. Among its many health benefits, it can improve agility, strength, posture and balance, which may reduce the risk of falls. Exercise may also modestly increase bone density. Falls are the precipitating cause of the majority of osteoporotic fractures, and an effective osteoporosis treatment regimen must include a program for fall prevention. Per USPSTF recommendation statement, Vitamin D supplementation is effective in preventing falls in community-dwelling adults aged 65 years or older who are at increased risk for falls.

8 Guideline Notes for Osteoporosis Screening Decision Sequence, March 2013 Page 8 Advise patients to stop tobacco smoking. The use of tobacco products is detrimental to the skeleton as well as to overall health. NOF strongly encourages a smoking cessation program as an osteoporosis intervention. Recognize and treat patients with excessive alcohol intake. Alcohol intake of three or more drinks per day may be detrimental to bone health, increases the risk of falling and requires further evaluation for alcoholism when identified. Caffeine should be limited to less than 1 to 2 servings per day. Visual function is important for reducing the risk of falls and trauma. Potential interventions include: o Regular visual exams, with corrective lenses prescribed as needed. o Medical and/or surgical intervention for eye conditions that reduce visual function. o Adequate area lighting in the home. o Night-lights. Trauma prevention is also important in reducing fractures. Potential interventions include: o Regular seat-belt use. o o Minimizing or eliminating use of intoxicants. Home safety precautions (remove throw rugs, install tub and shower non-slip adhesive strips, repair loose handrails and railings). Many medications can contribute to fracture risk through impact on balance, judgment, or alertness. Physicians are encouraged to use caution when considering prescription of such medications and to provide appropriate patient education about reducing the risk of medication-related trauma. Medication review for direct effects and drug-interaction potential is especially important for patients treated with multiple medications. Burden of Illness The medical and economic impact of osteoporosis is extensive, and is strongly related to the morbidity and mortality of fractures. This information is well-summarized in the literature. Refer to the sources cited at the beginning of this report. Scheduled Review Technology changes and additional research may lead to new recommendations. This guideline is reviewed annually. Trillium Medicaid providers are invited to submit comments and suggestions for consideration. Highlights of changes made in 2013 include: Removal of recommendation for menopausal women discontinuing estrogen. Addition of indications for vertebral imaging. Distribution This guideline information will be posted on the Trillium CHP web site and distributed to office managers. Implementation and Measurement Primary Care Physicians and their referral coordinators will use this guideline when evaluating referral requests related to osteoporosis screening. Specialists will use this guideline when considering osteoporosis screening and when planning patient education. Trillium does not have access to sufficiently broad sets of claims data to allow adequate measurement of the impact of this guideline on local clinical practice or cost of care.