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Osteoporosis and Bone Mineral Density Netee Papneja PGY4 Endocrinology Objectives To review the basic of Osteoporosis: definition, epidemiology, and risk factors To review the current Osteoporosis guidelines for women and men To review basics of BMD and it's interpretation What is Osteoporosis? A skeletal disorder - compromised bone strength (low bone mass and poor quality) = increased risk for fragility fracture Fragility fracture: occurs spontaneously or with low trauma from standing height or less Osteoporosis ◦ Fragility # represent 80% of all fractures in menopausal women > 50 ◦ 1-year mortality after hip fracture ranges 8.6% to 36% and only 25% return to baseline functioning Large care gap exists ◦ <20% of women receive therapies to reduce future fracture within the year following fracture and <10% of men! ◦ 60% of women with fragility fractures have non-osteoporotic bone mineral density (T-score >-2.5) Bessette L et al. The care gap in diagnosis and treatment o f women with a fragility fracture. Osteoporos Int 2008;19:79-86. Abrahamsen B et al. Excess mortality following hip fracture: a systematic epidemiological review. Osteoporos Int 2011;20:1633-50. Pathogenesis ◦ Low peak bone mass Consequence of peak bone mass accrued in utero and during childhood and puberty Genetic factors account for up to 85% of peak bone mass determinant Other influences: hormonal, nutritional, and environmental ◦ Increased bone re absorption (ex. Low Estrogen) ◦ Decreased bone formation (ex. Steroids) Secondary Osteoporosis Secondary osteoporosis (20% in women and 50% cause in men): ◦ ◦ ◦ ◦ ◦ ◦ ◦ Genetic Hypogonadism Endocrine Nutritional and GI related Hematologic and neoplastic Medication Induced Miscellaneous Endocrine Causes Disorders strongly associated with osteoporosis include: Endocrine: ◦ Primary hyperparathyroidism, Type I diabetes, Osteogenesis imperfecta in adults, Untreated long-standing hyperthyroidism, hypogonadism, Cushing’s disease menopause (<45 years) Chronic malnutrition or malabsorption Chronic liver disease Chronic inflammatory conditions How is the diagnosis of Osteoporosis Made? Can be made or suspected if + fragility # In pre-fracture patient, the WHO recommends making the diagnosis based on BMD value at lowest skeletal site: NORMAL: T- score over -1 OSTEOPENIA (Now replaced by LOW BONE MASS): T-score -1 TO -2.5 OSTEOPOROSIS: T-score over-2.5 BMD basics Measures bone mass to establish diagnosis of osteoporosis, predict risk of subsequent fractures and to monitor changes in BMD during therapy Methods of measuring BMD: ◦ Dual energy x-ray absorptiometry (DXA) ◦ Quantitative ultrasonography (QUS) ◦ Quantitative computed tomography (QCT) How does bone densitometry measure bone mass? Technique uses an ionizing radiation source (from a radionuclide or from xrays) and a radiation detector to measure amount of calcium in bone. Principle: bone will absorb radiation in proportion to it’s bone mineral content Bone mineral content then divided by measured area Dual energy x-ray absorptiometry (DXA) Preferred method of measuring bone mass DXA measures bone mineral content (BMC, in grams) and bone area (BA, cm2) ◦ "areal" BMD (aBMD) is calculated in g/cm2 by dividing BMC by BA Bone Mineral Density: DXA Patient on whole body scanner, with x-ray sources beneath a table and a detector overhead. Scanned with photons that are generated by 2 low-dose x-rays at different energy levels. The body's absorption of the photons at the two levels is measured. The ratios can be then used to predict total body fat, fat-free mass, and total body bone mineral. Advantages of DXA Scans precise, accurate, and reliable PRECISION ERROR (%) ACCURACY ERROR (%) RADIATION DOSE (mSV) Spine 1 5-8 1 Proximal femur 1-2 5-8 1 Total body 1 1-2 3 • Relatively short scanning times (few minutes) • low radiation exposure • DXA can also distinguish regional as well as whole body parameters of body composition. Disadvantages ◦ Initial cost of the equipment ◦ Significant differences in the technologies used by different manufacturers Same centre Same machine and calibration Same technician ◦ Contraindicated in pregnancy ◦ Careful of falsely low or high results Factors modifying bone mineral density INCREASED BMD DECREASED BMD HIP Excessive or inadequate internal hip rotation rotation Osteoarthritis Metal artifact Focal skeletal sclerosis Artifact overlying soft tissue Lytic lesions SPINE Osteophytes Focal skeletal pathology (i.e., sclerosis, metastasis) Vertebral compression # Vascular calcification Metal, radiology contrast, stones, calcium tablets or other artifact overlying spine Artifacts overlying soft tissues Rotoscoliosis Laminectomy Lytic lesions CARJ Vol 56, No 3, June 2005 179 What do results mean? What is a T score? Number of standard deviations above or below the mean bone mass of a normal young adult sex-match population ◦ A patient whose bone mass is 1 SD below that of the reference population has a T-score of -1.0 and has lost about 10% of bone mass What is a Z score? # of SD above/below the mean bone mass of an age- and sex- matched reference population Best bone to use? Hip is preferred because bone mass at hip site best correlates with risk of hip fractures (highest mortality and morbidity) Role of forearm bone mass? ◦ Useful in primary hyperparathyroidism, if patient overweight and cannot be scanned Main Focus…. Manage the patient according to their absolute fracture risk and not their BMD ◦ 60% of women with fragility fractures have non-osteoporotic bone mineral density (T-score >-2.5) Over-reliance on BMD: missed opportunity to prevent future fractures Screening Individuals over the age of 50 Anyone with a history of fragility fracture • A detailed history and physical exam can help identify individuals at high risk of fractures How do I assess for osteoporosis and fracture risk? History – identify RF for low BMD, future #, falls ◦ ◦ ◦ ◦ ◦ ◦ ◦ ◦ History of fracture Parental hip fracture Steriod use (>3months, 7.5mg) Smoker High alcohol intake (>3units/day) Inflammatory disorders (ie RA) Falls in last 1 year Gait and balance issues Screening Examination Parameter Weight Under 60 kg Weight loss ≥ 10% since age 25 Height (measure annually) Vertebral fracture assessment* Positive Results Prospective loss > 2 cm Historical height loss > 6 cm Rib-to-pelvis distance ≤ 2 fingers’ breadth Occiput-towall distance (kyphosis) > 5 cm Fall risk assessment: Get-up-and-go test Inability or difficulty performing test Long time (> 30 seconds) to complete2 *If vertebral fracture assessment is positive, screen for vertebral fracture using lateral spine x-ray 1. Papaioannou A, et al CMAJ 2010. JAMA Does this woman have osteoporosis? ◦ ◦ ◦ ◦ ◦ Weight < 51 kg LR+7.3 Tooth count <20 LR+ 3.4 Self-reported humpback LR +3.0 Rib Pelvis < 2 finger breadth LR+3.8 Wall to Occiput >0cm LR+4.6 Next Steps… BMD BMD for: 1. >65 2. Presence of fracture 3. Individuals who have risk factors Osteoporosis: Investigations • Recommended tests for for people with osteoporosis, defined as T-score ≤ -2.5: ◦ ◦ ◦ ◦ ◦ ◦ Calcium, corrected for albumin Complete blood count Creatinine Alkaline phosphatase Thyroid-stimulating hormone Serum protein electrophoresis (for patients with vertebral fractures) ◦ 25-Hydroxyvitamin D Osteoporosis: Risk Assessment Two tools available: ◦ Canadian Association of Radiologists and Osteoporosis Canada (CAROC) ◦ Fracture Risk Assessment tool (FRAX) Osteoporosis: Risk Assessment CAROC ◦ Uses age, sex, and femoral neck T-score ◦ 10-year risk of major osteoporotic fracture is determined ◦ 2 Risk factors raise a patient’s risk level to next category Fragility fracture after age 40 Prolonged systemic glucocorticoid use Osteoporosis: CAROC Osteoporosis: CAROC Osteoporosis: Risk Assessment FRAX ◦ Developed and recommended by the WHO ◦ Uses sex, age, femoral neck T-score (optionally), and: BMI Prior fracture Parental hip fracture Prolonged glucocorticoid use Rheumatoid arthritis (or secondary cause of osteoporosis) Current smoking Alcohol intake >3/d ◦ 10-year probability of major osteoporotic fracture and hip fracture is calculated as a % FRAX Tool: On-line Calculator www.shef.ac.uk/FRAX. CAROC Verses FRAX Both reflect risk assessment in treatment-naïve patients FRAX more complete, but complex to use, not available in BMD machines The CAROC tool is the only tool that can be applied nationally at the present time. 2010 CAROC tool is recommended for use in Canada by Osteoporosis Canada; it is also available in an electronic format. Treatment- Non pharmacological For ALL Patients 1. Exercise – Resistance, weight-bearing aerobic exercises, that enhance core stability and/or focus on balance (i.e. tai chi) 2. Hip protectors for LTC residents 3. Smoking cessation 4. Reduce alcohol 5. Fall-prevention strategies Osteoporosis: Calcium & Vit D New Osteoporosis Canada Guidelines: ◦ Adults over age 50 Total daily intake of elemental calcium (through diet and supplements) should be 1200 mg ◦ Healthy adults at low risk for vitamin D deficiency Vit D3 400-1000 IU daily ◦ Adults over age 50 at moderate risk of vitamin D deficiency Vit D3 800-1000 IU daily (up to 2000 IU may be required) Treatment CAROC stratification guides treatment decisions Women 0.0 Femoral neck T-score -0.5 -1.0 Low risk (<10%) -1.5 -2.0 Moderate risk (10-20%) -2.5 -3.0 -3.5 High risk (> 20%) -4.0 50 55 60 65 70 75 80 85 Age (years) Papaioannou A, et al CMAJ 2010. Pharmacological Treatment Low risk (10-year risk <10%) ◦ Treatment not recommended. Reassess risk in 5 years Moderate risk (10-year risk 10-20%) ◦ Consider treatment if additional risk factors or vertebral # present High risk (10-year risk >20%) ◦ Should be offered pharmacologic therapy Factors to Consider in moderate risk patients Fracture • vertebral fracture • Previous wrist fracture in individuals either > 65yrs or with a T-score ≤-2.5 BMD • Lumbar spine T-score << femoral neck T-score • Rapid bone loss Medications • Aromatase-inhibitor or androgen deprivation therapy • Long-term or repeated systemic glucocorticoid use not meeting conventional criteria for prolonged use Other • Recurrent falls (≥ 2 times in the past 12 months) • Disorders strongly associated with osteoporosis, rapid bone loss or fractures First-line therapies in post-menopausal women Based on GRADE A evidence Bone Formation Therapy Antiresorptive Therapy Type of Fracture Bisphosphonates Denosumab (Prolia) RANK ligand Inhibitor SERM Raloxifene * Estrogen ** (Hormone Therapy) Teriparatide (Forteo) PTH analog Alendronate Risedronate Zoledronic Acid Vertebral Hip - - Nonvertebral† - *For menopausal women can be used as a first-line for prevention of vertebral fractures **For menopausal women with vasomotor symptoms Papaioannou A, et al CMAJ 2010. Papaioannou A, Morin S. CMAJ. 2010.DOI:10.1503/cmaj.100771. Osteoporosis: Treatment Osteoporosis Canada Guidelines for Menopausal women: Second line therapy: calcitonin or etidronate for prevention of vertebral fractures [grade B] Treatment: Bisphosphonates Osteonecrosis of the jaw (ONJ) 1/100,000 pts/ yr ◦ nonhealing area of exposed bone in the jaw ◦ Commonly after dental procedures ◦ Mostly with higher doses of IV BP use for cancer, in patients with co-factors like chemo, radiation, steroids Atypical Fracture: subtrochanteric or shaft fracture 2/100,000 pts on 2yrs BP 78/100,000 pts on 8yrs BP Treatment: RANKL antibody 60mg SC q6months Denosumab (Prolia) is a monoclonal antibody against Rank Ligand ◦ Inhibits Rank Ligand, a protein which activates osteoclasts. Denosumab blocks osteoclast differentiation and reduces osteoclast numbers and thereby inhibiting bone reabsorption. Long-term safety data not available Not studied in men Used in: ◦ Patients who have failed, are intolerant of other therapies, poor adherence, patient preference ◦ Covered by OBD if 2/3 present: >75, BMD <-2.5, fracture Cummings SR et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009;361(8):756 Treatment: Recombinant PTH FORTEO® (teriparatide [rDNA origin] injection) 20 microgram SC OD x 2years $800/month Vertebral and Non Vertebral # prevention Consider using in: ◦ Men and women with severe osteoporosis who continue to fracture after bisphosphonate therapy ◦ Intolerance to bisphosphonates SERM Selective estrogen receptor modulatorRaloxifene (Evista) Reduces only vertebral fractures Breast Ca protection/no endometrial hyperplasia Increases risk of venous thromboembolism/hot flashes HRT reduce overall fractures with a relative risk reduction of 30% Risks associated with VTE, stroke and Breast Cancer Requires assessment of risks, benefits and patient preference Consider with intolerable menopausal symptoms Treatment: Calcitonin Binds to osteoclasts and inhibits bone reabsorption Can be given IM, SC, or intranasal Less efficacious than other therapies Reduces only vertebral # Can be considered in patients with back pain Duration of Bisphosphoates (BP) Treatment Large, RCTs show benefit of BP therapy for 3-4 yrs Only two RCT looking at use of BP beyond 5 years ◦ Fracture Intervention Trial Long-Term Extension (FLEX)- 1099 postmenopausal women on avg 5yrs of Alendronate to continue it or placebo for additional 5 yrs ◦ Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly (HORIZON) Extension trial- 3 years of treatment followed by 3 years of active extension (n = 616) or placebo ( n = 617) n engl j med 366;22 nejm.org may 31, 2012 FLEX and HORIZON trials: ◦ modest bone loss after D/C of therapy as compared to continued therapy ?persistent effect of alendronate (5 years) and zoledronic acid (3 years) ◦ Both showed significant reductions in the risk of vertebral # with continuation of bisphosphonate treatment ◦ Neither trial showed an overall reduction in nonvertebral fractures. n engl j med 366;22 nejm.org may 31, 2012 5-Yr Risk of Clinical Vertebral Fracture FN T score at start Placebo Alendronat e Risk Difference NNT ALL BMD 23/437 (5.5) 16/662 (2.5) 2.9 (0.3–5.4) 34 <-2.5 -2.5 to -2 >-2 11/132 (9.3) 9/126 (5.8) 3/179 (2.3) 9/190 (4.5) 3/185 (2.8) 4/282 (1.1) 4.8 (0.8–9.2) 3.0 (0.3–6.7) 1.2 (0.2–2.8) 21 33 81 6/75 (8.0) 3/82 (3.0) 2/130 (1.8) 4/109 (3.8) 1/121 (1.4) 2/203 (0.9) 4.2 (0.6–9.1) 1.6 (0.2–5.0) 1.0 (0.1–2.6) 24 63 102 No Vertebral # <-2.5 -2.5 to -2 >-2 Vertebral # <-2.5 Continuing for Osteoporosis 5/57 Bisphosphonates (11.1) 5/81 (5.3) 5.8 (0.8– 17 Osteoporosis: Treatment Monitoring: ◦ Treatment initiation: 1-3 years after Good response if BMD improves or stabilizes Poor response: Decrease in BMD greater than the least significant change (LSC) of the measuring facility adherence issues, undiagnosed secondary causes ◦ Moderate risk: repeat BMD testing in 1-3 years to assess for rapid decline in BMD ◦ Low risk individuals: repeat at 5-10 year interval Bone Turnover Markers (BMT) Prospective studies: increased levels of BTMs are associated with ~ two-fold increased # risk in women 65 and older In estimating the 10- year absolute risk of hip fracture, the combination of an elevated reabsorption marker (C-terminal telopeptide) with an osteoporotic BMD or a history of previous fracture resulted in a 70-100% higher risk than from BMD alone The value of BTMs still unclear, not integrated in any fracture risk assessment system. Monitoring: Cross-linked C-terminal telopeptides (CTX) proteolytic fragments of type 1 collagen formed during bone resorption high levels of CTX = higher rate of bone remodeling (turnover) Menopause = Low estrogen = reduced osteoblasts and thus accelerating the rate of bone loss: higher CTX antiresorptive therapy: CTX back to premenopausal level Interpretation: ◦ drop in CTX concentration of 35 to 55 percent from baseline levels after three to six months indicates effective antiresorptive therapy. ◦ Ineffective therapy or lack of compliance = absence of a decline Provides early indication of treatment response Changes in bone turnover can be detected in three months by measuring CTX testing for CTX is noninvasive and can be repeated often. Limitations variability of CTX due to diet, exercise, time of day, etc cannot replace BMD in diagnosing osteoporosis Although levels of CTX are associated with increased risk of fractures, the test cannot be used to predict fractures. Low GFR: CTX concentrations may be higher than expected due to reduced excretion of CTX Treatment Osteoporosis Guidelines for Men 2012 Evaluation with BMD ◦ >70 ◦ 50-69 yo if additional RF (ex. fragility #, steroids, hypogonadism, hyperparathyroidism, or COPD) Hyperparathyroidism or anti-androgen tx for prostate ca: measure forearm dXa (1/3 or 33% radius) Treatment- Lifestyle 1000–1200 mg calcium daily Obtain vitamin d levels > 75 nmol/liter weight-bearing activities for 30–40 min per session, 3-4/wk Etoh <3/day cease smoking Pharmacological Treatment for: ◦ ◦ ◦ ◦ hip or vertebral fragility fracture BMD below -2.5 at any site >20% 10yr risk of fracture Long term steroids Options ◦ alendronate, risedronate, zoledronic acid, and Forteo; also Prolia for men receiving adT for prostate cancer Special Groups hypogonadal men ◦ High risk: Testosterone + bisphosphonate or Forteo ◦ Borderline high risk: Testosterone if it’s <6.9nmol/L and positive signs of symptoms low androgen or chronic hypogonadism (due to HPA problem) Men with prostate cancer receiving ADT ◦ High risk: Recommend pharmacological treatment of OP Monitoring BMD q1-2 years until plateau reached, then reduce frequency consider measuring a bone turnover marker (CTX) at 3–6 months after initiation for anabolic therapy (Forteo) Summary Osteoporosis is prevalent and causes a great burden by increasing fractures Assessment of osteoporosis should include determination of risk factors and BMD Two validated tools (CAROC and FRAX) are available for fracture risk assessment in Canada Pharmacologic treatment is guided by risk level Thank you! Special thanks to Dr. Paul and Ronen