Development and validation of a one year predictive model for secondary fractures in osteoporosis.

The number of osteoporosis-related fractures in the United States is no longer declining. Existing risk-based assessment tools focus on long-term risk. Payers and prescribers need additional tools to identify patients at risk for imminent fracture. We developed and validated a predictive model for secondary osteoporosis fractures in the year following an index fracture using administrative medical and pharmacy claims from the Optum Research Database and Symphony Health, PatientSource. Patients ≥50 years with a case-qualifying fracture identified using a validated claims-based algorithm were included. Logistic regression models were created with binary outcome of a second fracture versus no second fracture within a year of index fracture, with the goal of predicting second fracture occurrence. In the Optum Research Database, 197,104 patients were identified with a case-qualifying fracture (43% commercial, 57% Medicare Advantage). Using Symphony data, 1,852,818 met the inclusion/exclusion criteria. Average patient age was 70.09 (SD = 11.09) and 71.28 (SD = 14.24) years in the Optum Research Database and Symphony data, respectively. With the exception of history of falls (41.26% vs 18.74%) and opioid use (62.80% vs 46.78%), which were both higher in the Optum Research Database, the two populations were mostly comparable. A history of falls and steroid use, which were previously associated with increased fracture risk, continue to play an important role in secondary fractures. Conditions associated with bone health (liver disease), or those requiring medications that impact bone health (respiratory disease), and cardiovascular disease and stroke-which may share etiology or risk factors with osteoporosis fractures-were also predictors of imminent fractures. The model highlights the importance of assessment of patient characteristics beyond bone density, including patient comorbidities and concomitant medications associated with increased fall and fracture risk, in alignment with recently issued clinical guidelines for osteoporosis treatment.

Cost-effectiveness of secondary fracture prevention intervention for Medicare beneficiaries.

BACKGROUND: Secondary fracture prevention intervention such as fracture liaison services are effective for increasing osteoporosis treatment rates, but are not currently widely used in the United States. We evaluated the cost-effectiveness of secondary fracture prevention intervention after osteoporotic fracture for Medicare beneficiaries. METHODS: An individual-level state-transition microsimulation model was developed to evaluate the cost-effectiveness of secondary fracture prevention intervention compared with usual care for U.S. Medicare patients aged 65 and older who experience a new osteoporotic fracture. Patients who initiated pharmacotherapy and remained adherent were assumed to be treated for 5 years. Outcome measures included subsequent fractures, average lifetime costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios in 2020 U.S. dollars per QALY gained. The model time horizon was lifetime, and analysis perspective was payer. RESULTS: Base-case analysis results showed that the secondary fracture prevention intervention strategy was both more effective and less expensive than usual care-thus, it was cost-saving. Model findings indicated that the intervention would reduce the number of expected fractures by approximately 5% over a 5-year period, preventing approximately 30,000 fractures for 1 million patients. Secondary fracture prevention intervention resulted in an average cost savings of $418 and an increase in QALYs of 0.0299 per patient over the lifetime; for 1 million patients who receive the intervention instead of usual care, expected cost savings for Medicare would be $418 million dollars. One-way and probabilistic sensitivity analyses supported base-case findings of cost savings. CONCLUSION: Secondary fracture prevention intervention for Medicare beneficiaries after a new osteoporotic fracture is very likely to both improve health outcomes and reduce healthcare costs compared with usual care. Expansion of its use for this population is strongly recommended.

The Nursing Home Physical Performance Test: A Secondary Data Analysis of Women in Long-Term Care Using Item Response Theory.

Background and Objectives: The Nursing Home Physical Performance Test (NHPPT) was developed to measure function among nursing home residents using sit-to-stand, scooping applesauce, face washing, dialing phone, putting on sweater, and ambulating tasks. Using item response theory, we explore its measurement characteristics at item level and opportunities for improvements. Research Design and Methods: We used data from long-term care women. We fitted a graded response model, estimated parameters, and constructed probability and information curves. We identified items to be targeted toward lower and higher functioning persons to increase the range of abilities to which the instrument is applicable. We revised the scoring by making sit-to-stand and sweater items harder and dialing phone easier. We examined changes to concurrent validity with activities of daily living (ADL), frailty, and cognitive function. Results: Participants were 86 years old, had more than three comorbidities, and a NHPPT of 19.4. All items had high discrimination and were targeted toward the lower middle range of performance continuum. After revision, sit-to-stand and sweater items demonstrated greater discrimination among the higher functioning and/or greater spread of thresholds for response categories. The overall test showed discrimination over a wider range of individuals. Concurrent validity correlation improved from 0.60 to 0.68 for instrumental ADL and explained variability (R2) from 22% to 36% for frailty. Discussion and Implications: NHPPT has good measurement characteristics at the item level. NHPPT can be improved, implemented in computerized adaptive testing, and combined with self-report for greater utility, but a definitive study is needed.

The National Osteoporosis Foundation's methods and processes for developing position statements.

The methods and processes described in this manuscript have been approved and adopted by the NOF Board of Trustees on November 11, 2015. This manuscript has been peer-reviewed by the NOF Research Committee and Osteoporosis International. The National Osteoporosis Foundation frequently publishes position statements for the benefit of educating healthcare professionals and the general public on a particular issue and/or concern related to preventing osteoporosis and/or promoting strong bones throughout the lifespan. This manuscript represents the official methods and processes adopted by the NOF Board of Trustees for the purpose developing future position statements in a transparent and unbiased manner.

Cost-Effectiveness of Osteoporosis Screening Strategies for Men.

Osteoporosis affects many men, with significant morbidity and mortality. However, the best osteoporosis screening strategies for men are unknown. We developed an individual-level state-transition cost-effectiveness model with a lifetime time horizon to identify the cost-effectiveness of different osteoporosis screening strategies for US men involving various screening tests (dual-energy X-ray absorptiometry [DXA]; the Osteoporosis Self-Assessment Tool [OST]; or a fracture risk assessment strategy using age, femoral neck bone mineral density [BMD], and Vertebral Fracture Assessment [VFA]); screening initiation ages (50, 60, 70, or 80 years); and repeat screening intervals (5 years or 10 years). In base-case analysis, no screening was a less effective option than all other strategies evaluated; furthermore, no screening was more expensive than all strategies that involved screening with DXA or the OST risk assessment instrument, and thus no screening was "dominated" by screening with DXA or OST at all evaluated screening initiation ages and repeat screening intervals. Screening strategies that most frequently appeared as most cost-effective in base-case analyses and one-way sensitivity analyses when assuming willingness-to-pay of $50,000/quality-adjusted life-year (QALY) or $100,000/QALY included screening initiation at age 50 years with the fracture risk assessment strategy and repeat screening every 10 years; screening initiation at age 50 years with fracture risk assessment and repeat screening every 5 years; and screening initiation at age 50 years with DXA and repeat screening every 5 years. In conclusion, expansion of osteoporosis screening for US men to initiate routine screening at age 50 or 60 years would be expected to be effective and of good value for improving health outcomes. A fracture risk assessment strategy using variables of age, femoral neck BMD, and VFA is likely to be the most effective of the evaluated strategies within accepted cost-effectiveness parameters. DXA and OST are also reasonable screening options, albeit likely slightly less effective than the evaluated fracture risk assessment strategy. © 2016 American Society for Bone and Mineral Research.

Impact of generic alendronate cost on the cost-effectiveness of osteoporosis screening and treatment.

INTRODUCTION: Since alendronate became available in generic form in the Unites States in 2008, its price has been decreasing. The objective of this study was to investigate the impact of alendronate cost on the cost-effectiveness of osteoporosis screening and treatment in postmenopausal women. METHODS: Microsimulation cost-effectiveness model of osteoporosis screening and treatment for U.S. women age 65 and older. We assumed screening initiation at age 65 with central dual-energy x-ray absorptiometry (DXA), and alendronate treatment for individuals with osteoporosis; with a comparator of "no screening" and treatment only after fracture occurrence. We evaluated annual alendronate costs of $20 through $800; outcome measures included fractures; nursing home admission; medication adverse events; death; costs; quality-adjusted life-years (QALYs); and incremental cost-effectiveness ratios (ICERs) in 2010 U.S. dollars per QALY gained. A lifetime time horizon was used, and direct costs were included. Base-case and sensitivity analyses were performed. RESULTS: Base-case analysis results showed that at annual alendronate costs of $200 or less, osteoporosis screening followed by treatment was cost-saving, resulting in lower total costs than no screening as well as more QALYs (10.6 additional quality-adjusted life-days). When assuming alendronate costs of $400 through $800, screening and treatment resulted in greater lifetime costs than no screening but was highly cost-effective, with ICERs ranging from $714 per QALY gained through $13,902 per QALY gained. Probabilistic sensitivity analyses revealed that the cost-effectiveness of osteoporosis screening followed by alendronate treatment was robust to joint input parameter estimate variation at a willingness-to-pay threshold of $50,000/QALY at all alendronate costs evaluated. CONCLUSIONS: Osteoporosis screening followed by alendronate treatment is effective and highly cost-effective for postmenopausal women across a range of alendronate costs, and may be cost-saving at annual alendronate costs of $200 or less.

Cost-effectiveness of different screening strategies for osteoporosis in postmenopausal women.

BACKGROUND: The best strategies to screen postmenopausal women for osteoporosis are not clear. OBJECTIVE: To identify the cost-effectiveness of various screening strategies. DESIGN: Individual-level state-transition cost-effectiveness model. DATA SOURCES: Published literature. TARGET POPULATION: U.S. women aged 55 years or older. TIME HORIZON: Lifetime. PERSPECTIVE: Payer. INTERVENTION: Screening strategies composed of alternative tests (central dual-energy x-ray absorptiometry [DXA], calcaneal quantitative ultrasonography [QUS], and the Simple Calculated Osteoporosis Risk Estimation [SCORE] tool) initiation ages, treatment thresholds, and rescreening intervals. Oral bisphosphonate treatment was assumed, with a base-case adherence rate of 50% and a 5-year on/off treatment pattern. OUTCOME MEASURES: Incremental cost-effectiveness ratios (2010 U.S. dollars per quality-adjusted life-year [QALY] gained). RESULTS OF BASE-CASE ANALYSIS: At all evaluated ages, screening was superior to not screening. In general, quality-adjusted life-days gained with screening tended to increase with age. At all initiation ages, the best strategy with an incremental cost-effectiveness ratio (ICER) of less than $50,000 per QALY was DXA screening with a T-score threshold of -2.5 or less for treatment and with follow-up screening every 5 years. Across screening initiation ages, the best strategy with an ICER less than $50,000 per QALY was initiation of screening at age 55 years by using DXA -2.5 with rescreening every 5 years. The best strategy with an ICER less than $100,000 per QALY was initiation of screening at age 55 years by using DXA with a T-score threshold of -2.0 or less for treatment and then rescreening every 10 years. No other strategy that involved treatment of women with osteopenia had an ICER less than $100,000 per QALY. Many other strategies, including strategies with SCORE or QUS prescreening, were also cost-effective, and in general the differences in effectiveness and costs between evaluated strategies was small. RESULTS OF SENSITIVITY ANALYSIS: Probabilistic sensitivity analysis did not reveal a consistently superior strategy. LIMITATIONS: Data were primarily from white women. Screening initiation at ages younger than 55 years were not examined. Only osteoporotic fractures of the hip, vertebrae, and wrist were modeled. CONCLUSION: Many strategies for postmenopausal osteoporosis screening are effective and cost-effective, including strategies involving screening initiation at age 55 years. No strategy substantially outperforms another. PRIMARY FUNDING SOURCE: National Center for Research Resources.

Osteoporosis screening preferences of older adults.

We aimed to examine older adults' osteoporosis screening test preferences, willingness to travel for screening, and willingness to pay for screening. A survey was mailed to 1830 women and men aged 60 yr or older in Pennsylvania, assessing screening test preference (among dual-energy X-ray absorptiometry [DXA], heel quantitative ultrasound [QUS], and risk-assessment tools), willingness to travel 20 miles for a better screening test, and willingness to pay $100 for a better screening test, as well as socio-demographic and health-related characteristics. Analyses included descriptive statistics and multivariable logistic regression analyses to evaluate association between screening test preference, willingness to travel, willingness to pay, and potential explanatory variables. Surveys were completed by 1268 individuals (69.3%). Most respondents indicated a screening test preference (73.9%) and, of these, 78.1% preferred DXA. 78.8% of the respondents indicated that they may be willing to travel 20 miles for a better test, and 51.2% indicated that they may be willing to pay $100 for a better test. Similar trends were observed in analyses including only individuals who had not had prior osteoporosis testing or diagnosis. Many older individuals would prefer the "best" test for osteoporosis screening, and may be willing to travel or pay more to obtain a better test.