Faculty/Presenter Disclosure • Faculty: Gillian Hawker • Program: 51st Annual Scientific Assembly • Relationships with commercial interests: – – – – Grants/Research Support: PharmaCorp ABC Speakers Bureau/Honoraria: XYZ Biopharmaceuticals Ltd. Consulting Fees: MedX Group Inc. Other: Employee of XXY Hospital Group Disclosure of Commercial Support • This program has received financial support [ organization name] from in the form of [describe support here – e.g. an educational grant]. • This program has received in-kind support from [organization name] in the form of [describe support here – e.g. logistical support]. • Potential for conflict(s) of interest: – [Speaker/Faculty name] has received [payment/funding, etc.] from [organization supporting this program AND/OR organization whose product(s) are being discussed in this program]. – [Supporting organization name] [developed/licenses/distributes/benefits from the sale of, etc.] a product that will be discussed in this program: [insert generic and brand name here]. Mitigating Potential Bias • [Explain how potential sources of bias identified in slides 1 and 2 have been mitigated]. • Refer to “Quick Tips” document Bone Mineral Density Testing: Who, When and What For? Dr Gillian Hawker Ontario College of Family Physicians Annual Scientific Assembly November 28-30, 2013 Disclosures • Contract from the Ontario MOHLTC Osteoporosis Strategy Outline • Why do we assess Bone Mineral Density (BMD)? • How do we assess BMD? • What are the pitfalls of BMD testing? • When should BMD be assessed? • What is the role of BMD in fracture risk assessment / treatment decision making? Ontario College of Family Physicians Annual Scientific Assembly WHY ORDER A BMD TEST? Why order a BMD test? • To make a diagnosis of osteoporosis / low bone mass in high risk populations – Younger people with medical conditions, e.g. celiac disease, IBD on steroids, cancer chemotherapy • To evaluate fracture risk in patients at increased risk for fracture – Older people How do we assess BMD? • DXA = dual energy x-ray absorptiometry • Measures BMD at: – Lumbar spine (L1-L4) – Hip • Femoral neck • Total hip – Radius – Total body • Low radiation exposure What does DXA measure? Bone Quantity Bone Quality – BMD – bone size – bone mass – architecture – bone turnover – bone properties mineralization micro-damage DXA measures the Bone Strength = density of bone Bone Quantity + Bone Quality mineral Two types of bone • Trabecular bone: • 20% of total bone, 80% of bone turnover • Cortical bone: • 80% of bone, 20% of bone turnover Most susceptible to effects of illness May be relatively preserved when spine BMD 11 What are we measuring? Measurement Site: Trabecular Bone Cortical Bone Lumbar spine ++ + Femoral neck + ++ Total hip + ++ Radius ++ ++ Ontario College of Family Physicians Annual Scientific Assembly POTENTIAL PITFALLS OF DXA Limitations of DXA • Not portable • Doesn’t provide any information about bone architecture, which can influence fracture risk independent of BMD • Many factors interfere with accuracy (technical issues, artifact) • Measures calcium mineral in bone, thus may be falsely low with vitamin D deficiency (unmineralized bone) • Cost Factors Affecting BMD Accuracy • Test Performance – Technical Problems • Positioning of patient • Estimating “density” from two dimensions – Artifact • • • • Spine degenerative change (extra bone) Changes in body mass Hardware Fracture Some Examples… Degenerative changes in spine L1 compression fracture Hip positioning Hip rotation – lesser trochanter visible – c.w. baseline scan, shows 9.5% loss Hip positioning changed Now, compared with baseline scan, no significant change! Ontario College of Family Physicians Annual Scientific Assembly WHEN SHOULD BMD BE ASSESSED? Screening versus Case Finding • Screening: – Entire population tested irrespective of ‘risk factors’, e.g. mammography at age 50 • Men and women age 65+ years • Case Finding: – Test subset of the population based on presence / absence of risk factors • BMD testing in men and women < 65 years of age – 50-64 years – < 50 years Case Finding Approach Clinical risk factors Assess OP / fracture risk Low risk Reassure Moderate-High risk Assess bone density Calculate fracture risk Low Reassure Moderate-High Consider Rx Indications for BMD Testing in Older Adults 2010 Osteoporosis Canada Guidelines • All women and men age > 65 Indications for BMD Testing in Adults 50-64 Years 2010 Osteoporosis Canada Guidelines • Postmenopausal women & men aged 50 – 64 with clinical risk factors for fracture: – – – – – – – – – – Fragility fracture after age 40 Prolonged glucocorticoid use† Other high-risk medication use* Parental hip fracture Vertebral fracture or low bone mass on X-ray Current smoking High alcohol intake Low body wt (<60 kg) or major wt loss (>10% weight at age 25) Rheumatoid arthritis (inflammatory arthritis) Other disorders strongly associated with osteoporosis †≥ 3 months in prior year at dose ≥ 7.5 mg daily; * e.g. aromatase inhibitors, androgen deprivation therapy. These risk factors largely based on unadjusted estimates in women aged > 65 years 4/13/2015 What About Women at Menopause? • Systematic literature review of risk factors for low BMD/fracture in healthy women aged 40-60 years • Results – Good evidence: low body weight and post-menopausal status – Good or fair evidence: alcohol and caffeine intake, reproductive history are not risk factors – Inconsistent or insufficient evidence: calcium intake, physical activity, smoking, age at menarche, history of amenorrhea, family history of OP, race and current age on BMD Waugh et al, Osteoporosis International 2009 Risk Factors for Low BMD in Women at Menopause • In healthy women 40-60 years having first BMD test, determined the combination of risk factors that best discriminated women with/without low bone mass (T-score ≤ 2.0) • 944 eligible women (77%) participated – 87 (9.2%) had low bone mass (35 pre-/peri- + 52 post-menopausal) • Four independent risk factors identified: – – – – weight of ≤70 kg older age > number of years post menopause fragility fracture after age 40 Hawker G et al Osteoporosis International 2012 Indications for BMD Testing for Individuals Under Age 50 Years • Clinical risk factors for osteoporosis / bone loss or fracture Making a Diagnosis of Low Bone Mass or Osteoporosis Age Category Criteria* Below expected range for age Z-score < -2.0 Within expected range for age Z-score > -2.0 Severe (established) osteoporosis T-score < -2.5 with fragility fracture Osteoporosis T-score < -2.5 Low bone mass T-score -1.1 to -2.4 Normal T-score > -1.0 < 50 years > 50 years Which T score to use? • BMD reporting is based upon lowest value for lumbar spine (minimum two vertebral levels), total hip, and femoral neck – If either the lumbar spine or hip is invalid, then the forearm should be scanned and the distal one-third radius reported Ontario College of Family Physicians Annual Scientific Assembly ROLE OF BMD TESTING IN FRACTURE RISK ASSESSMENT Value of BMD Assessment • Key risk factor for fracture – We treat fracture risk not bone density! • Baseline assessment in those with conditions/ treatments associated with accelerated bone loss • ‘Fragility fracture’ work up Absolute 10-year Fracture-Risk Tools • Tools validated in Canada (choice based on personal preference and convenience) – CAROC: Joint initiative of the Canadian Association of Radiologists and Osteoporosis Canada1 – FRAX: Fracture Risk Assessment Tool developed by the World Health Organization2 • There are large differences in fracture rates from country to country3-5 – Assessment tools need to be country specific 1. Leslie WD, Berger C, et al. Osteoporosi Int; In press.. 2. Leslie WD, Lix LM, et al. Osteoporosi Int; In press. 3. Kanis JA, et al. J Bone Miner Res 2002; 17(7):1237-1244. 4. Melton LJ, III. Endocrinol Metab Clin North Am 2003; 32(1):1-13. 5. Leslie WD, et al. J Bone Miner Res 2010; in press. Variations in Estimated FRAX 10-Year Fracture Probabilities According to Country Canada 10-Year Major Fracture Probability Age 65 years, prior fracture with femoral neck T-score -2.5 30 Female Male 20 15 10 Turkey China Lebanon Spain US Black New Zealand France US Asian US Hispanic Germany Finland Hong Kong Argentina Italy Japan Belgium CANADA United Kingdom Austria US Caucasian 0 Switzerland 5 Sweden Percent fracture 25 Version 3.1 FRAX website (www.sheffield.ac.uk/FRAX 10-Year Hip Fracture Probability Age 65 years, prior fracture with femoral neck T-score -2.5 10-year Risk Assessment: CAROC • Provides estimate of 10-year absolute risk of a major osteoporotic fracture* in postmenopausal women and men over age 50 (no Rx) based on age, sex, and T-score at the femoral neck – Low: < 10% – Moderate 10-20% – High: > 20% * Including hip, spine, forearm, and proximal humerus Siminoski K, et al. Can Assoc Radiol J 2005 10-year Risk Assessment for Women (CAROC Base Risk) Papaioannou A, et al. CMAJ 2010 10-year Risk Assessment for Men (CAROC Base Risk) Risk Assessment with CAROC: Important Additional Risk Factors • Factors that increase CAROC risk by one category (i.e., from low to moderate or moderate to high) – Fragility fracture after age 40* – Recent prolonged systemic glucocorticoid use * Hip, vertebral fracture, or multiple fracture events should be considered high risk Siminoski K, et al. Can Assoc Radiol J 2005; 56(3):178-188. Kanis JA, et al. J Bone Miner Res 2004; 19(6):893-899. Impact of Prior Vertebral Fracture on Risk Assessment • Vertebral fractures unrelated to trauma are associated with a 5X risk for another vertebral fracture • A fracture detected from x-ray alone should be considered a prior fracture If moderate fracture risk, consider spine xray to rule out VF Risk Assessment Using FRAX • Uses age, sex, femoral neck BMD, and additional clinical risk factors to calculate 10-year fracture risk (composite* and hip only) – Additional risk factors: parental hip fracture, prior fracture, glucocorticoid use, current smoking, high alcohol intake, rheumatoid arthritis • Validated for use in Canada • Online FRAX calculator: www.shef.ac.uk/FRAX * composite of hip, vertebra, forearm, and humerus Leslie WD, et al. Osteoporos Int. FRAX Tool: On-line Calculator www.shef.ac.uk/FRAX. Issue with Reliance on Hip BMD CAROC and FRAX • Situations with accelerated bone loss – Rate of bone loss in trabecular bone >> cortical bone – Not uncommon to see a woman with very low bone mass in spine before loss in hip (especially if physically active) Ontario College of Family Physicians Annual Scientific Assembly CURRENT USE OF BMD TESTS Lack of Clarity about Referral Criteria • 2010 survey of 2594 FPs – 68% aware of CAROC guidelines, but 58% relied on the DXA T-score alone for dx/rx of post-menopausal osteoporosis Papaioannou et al., 2011 • Qualitative study of 22 FPs identified lack of clarity re: Munce et al., ASBMR 2013 – Appropriate age for baseline BMD testing • tendency for baseline referral at menopause in the absence of other clinical risk factors – Follow-up intervals for BMD testing Lack of Clarity leads to… • Inappropriate testing results in: – overuse in low risk populations (i.e., perimenopausal women) – underuse in high risk populations (age ≥ 65, or recent fracture) • Inaccurate fracture risk assessment – If referrals do not include key risk factors, e.g. prior fracture Over-testing • Of 944 women aged 40-60 years referred for baseline BMD assessment: – 9% had low bone mass – 4% had osteoporosis (Hawker et al., 2012) • In 2007/2008, women 40-59 years accounted for 46% of all BMD tests performed (OHIP, 2009) Under-testing • April 1, 2008 physician reimbursement for BMD revised - interval for re-assessment in individuals with low risk of osteoporosis lengthened (to restrict access to testing in low risk women) • Resulted in a reduction in overall BMD testing in both low risk and high risk populations (i.e., those with a recent fragility fracture) (Jaglal et al., submitted) Inaccurate Fracture Risk Reporting • 2008 survey of BMD reports in people with recent fracture, 50% did not mention prior fracture (Allin et al., 2012) – Fracture risk thus based on BMD alone → underestimated – Often this information not included in referral, not assessed by technologist Ontario College of Family Physicians Annual Scientific Assembly EFFORTS TO IMPROVE APPROPRIATE BMD TESTING Ontario Osteoporosis Strategy 1) Health Promotion 2) BMD Testing, Access & Quality 3) Post Fracture Care 4) Professional Education 5) Research and Evaluation Increase senior’s knowledge of osteoporosis and improve bone health of seniors and school children Improve the appropriate use, and accuracy of BMD testing in populations at risk of osteoporosis and fractures to improve early diagnosis of osteoporosis Enhance the integration of osteoporosis services across the entire spectrum of care to improve osteoporosis treatment and management Improve medical professionals’ use of clinical practice guidelines through interdisciplinary standards of care, decision aids and other osteoporosis resources Support mechanisms to drive and sustain Op strategy: evaluation to ensure planned outcomes are achieved and effective knowledge transfer Goal: To reduce fractures, morbidity, mortality and costs from osteoporosis through an integrated and comprehensive approach aimed at health promotion and disease management. Purpose of a Recommended Use Requisition (RUR) • To promote appropriate BMD testing – testing in individuals at high risk – testing in individuals at low risk • To encourage communication of necessary clinical risk factors to reading specialists making fracture risk assessments more accurate Development of the RUR • Ontario BMD Working Group comprised of FPs, radiologists, a BMD technician, and osteoporosis specialists • Interviews with FPs and reporting specialists • Modifications based on consultation with developers of standardized requisitions in Manitoba, British Columbia, and Nova Scotia • Major diagnostic imaging centres that perform BMD testing have reviewed and verified that the RUR is acceptable to them Components of the RUR (1) • Baseline BMD Test – Age ≥ 65 (no previous BMD test) – Menopausal (≥ 1 year post cessation of menstrual periods) with body weight < 60kg and men 50-64 with body weight < 60kg – Any of the following risk factors (check ALL that apply): • • • • • History of fragility fracture (after age 40) Recent prolonged glucocorticoid use Other high risk medication Rheumatoid arthritis Secondary disorder associated with rapid bone loss, fracture, or osteoporosis Components of the RUR (2) • Follow-up BMD Test – Patient is eligible for a BMD Test after 1 year if: • Has a new fragility fracture • Has a risk factor for bone loss and reported bone loss of >1% per year on prior BMD • Has a risk factor for bone loss and T-score < -1.0 on prior BMD – IF NOT, • OHIP will cover a second BMD test after 3 years from the baseline test • OHIP will cover a successive BMD test (3rd or more) after 5 years from the last test Proposed RUR Next Steps • Pilot testing of the RUR with approximately 30 FPs from across Ontario to further elucidate barriers to implementation • Integration and pilot testing of the RUR at the Women’s College Hospital Family Health Team • Submission of a cluster RCT to CIHR (September 2013) to evaluate the effectiveness of the RUR Summary • Perform BMD test using DXA to diagnose low bone mass / osteoporosis, which is a key risk factor for fragility fracture • Both performance and reporting issues with DXA testing – important to know your lab, provide risk factors in referral • BMD should be assessed in ALL women and men aged 65+ years (screening) and in younger individuals ONLY with risk factors for OP or fracture • Treatment decision making should be based on a composite assessment of fracture risk using CAROC or FRAX Canada, which incorporates BMD testing Thank You!