Showing papers by "Susan L. Greenspan published in 2021"

How has COVID-19 affected the treatment of osteoporosis? An IOF-NOF-ESCEO global survey.

Abstract: The effects of COVID-19 have the potential to impact on the management of chronic diseases including osteoporosis. A global survey has demonstrated that these impacts include an increase in telemedicine consultations, delays in DXA scanning, interruptions in the supply of medications and reductions in parenteral medication delivery. The COVID-19 pandemic has had profound effects on the health of the global population both directly, via the sequelae of the infection, and indirectly, including the relative neglect of chronic disease management. Together the International Osteoporosis Foundation and National Osteoporosis Foundation sought to ascertain the impact on osteoporosis management. Questionnaires were electronically circulated to a sample of members of both learned bodies and included information regarding the location and specialty of respondents, current extent of face to face consultations, alterations in osteoporosis risk assessment, telemedicine experience, alterations to medication ascertainment and delivery and electronic health record (EHR) utilisation. Responses were collected, quantitative data analysed, and qualitative data assessed for recurring themes. Responses were received from 209 healthcare workers from 53 countries, including 28% from Europe, 24% from North America, 19% from the Asia Pacific region, 17% from the Middle East and 12% from Latin America. Most respondents were physicians (85%) with physician assistants, physical therapists and nurses/nurse practitioners represented in the sample. The main three specialties represented included rheumatology (40%), endocrinology (22%) and orthopaedics (15%). In terms of the type of patient contact, 33% of respondents conducted telephone consultations and 21% video consultations. Bone mineral density assessment by dual-energy X-ray absorptiometry (DXA) usage was affected with only 29% able to obtain a scan as recommended. The majority of clinicians (60%) had systems in place to identify patients receiving parenteral medication, and 43% of clinicians reported difficulty in arranging appropriate osteoporosis medications during the COVID-19 crisis. To conclude through surveying a global sample of osteoporosis healthcare professionals, we have observed an increase in telemedicine consultations, delays in DXA scanning, interrupted supply of medications and reductions in parenteral medication delivery.

Effect of a Multifactorial Fall Injury Prevention Intervention on Patient Well-Being: The STRIDE Study

Abstract: Author(s): Gill, Thomas M; Bhasin, Shalender; Reuben, David B; Latham, Nancy K; Araujo, Katy; Ganz, David A; Boult, Chad; Wu, Albert W; Magaziner, Jay; Alexander, Neil; Wallace, Robert B; Miller, Michael E; Travison, Thomas G; Greenspan, Susan L; Gurwitz, Jerry H; Rich, Jeremy; Volpi, Elena; Waring, Stephen C; Manini, Todd M; Min, Lillian C; Teresi, Jeanne; Dykes, Patricia C; McMahon, Siobhan; McGloin, Joanne M; Skokos, Eleni A; Charpentier, Peter; Basaria, Shehzad; Duncan, Pamela W; Storer, Thomas W; Gazarian, Priscilla; Allore, Heather G; Dziura, James; Esserman, Denise; Carnie, Martha B; Hanson, Catherine; Ko, Fred; Resnick, Neil M; Wiggins, Jocelyn; Lu, Charles; Meng, Can; Goehring, Lori; Fagan, Maureen; Correa-de-Araujo, Rosaly; Casteel, Carri; Peduzzi, Peter; Greene, Erich J | Abstract: Background/objectivesIn the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study, a multifactorial intervention was associated with a nonsignificant 8% reduction in time to first serious fall injury but a significant 10% reduction in time to first self-reported fall injury relative to enhanced usual care. The effect of the intervention on other outcomes important to patients has not yet been reported. We aimed to evaluate the effect of the intervention on patient well-being including concern about falling, anxiety, depression, physical function, and disability.DesignPragmatic cluster-randomized trial of 5,451 community-living persons at high risk for serious fall injuries.SettingA total of 86 primary care practices within 10 U.S. healthcare systems.ParticipantsA random subsample of 743 persons aged 75 and older.MeasurementsThe well-being measures, assessed at baseline, 12 months, and 24 months, included a modified version of the Fall Efficacy Scale, Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and depression scales, and Late-Life Function and Disability Instrument.ResultsParticipants in the intervention (n = 384) and control groups (n = 359) were comparable in age: mean (standard deviation) of 81.9 (4.7) versus 81.8 (5.0) years. Mean scores were similar between groups at 12 and 24 months for concern about falling, physical function, and disability, whereas the intervention group's mean scores on anxiety and depression were .7 points lower (i.e., better) at 12 months and .6 to .8 points lower at 24 months. For each of these outcomes, differences between the groups' adjusted least square mean changes from baseline to 12 and 24 months, respectively, were quantitatively small. The overall difference in means between groups over 2 years was statistically significant only for depression, favoring the intervention: -1.19 (99% confidence interval, -2.36 to -.02), with 3.5 points representing a minimally important difference.ConclusionsSTRIDE's multifactorial intervention to reduce fall injuries was not associated with clinically meaningful improvements in patient well-being.

Group Lifestyle Phone Maintenance for Weight, Health, and Physical Function in Adults Aged 65-80 Years: A Randomized Clinical Trial.

Abstract: Background Group lifestyle sessions with phone maintenance could improve weight, health, and function in vulnerable older adults. Methods Community-dwelling adults (N = 322) with body mass index (BMI, kg/m2) ≥27 and additional risk factors received 12 one-hour in-person behavioral weight management group sessions then were randomized to 8 half-hour telephone sessions (n = 162) or newsletter control (n = 160) from 4 to 12 months with no treatment contact thereafter. Primary outcome was 0- to 12-month weight change. Cardiometabolic, short physical performance battery (SPPB), and self-reported activity changes were assessed at 12 and 24 months. Results At baseline, the mean (SD) age was 71.2 (4.3) and BMI was 33.8 (5.1). Participants were 77% women, 13% Black, 85% retired, averaging 4 medical conditions, and taking blood pressure (67.4%) and lipid-lowering (51.6%) medications. At 12 months, a greater proportion of the phone group (66.0%) achieved ≥5% weight loss compared with newsletter control (53.2%; p = .02). Mean (95% CI) weight loss was greater for phone (-6.6 kg [-7.5, -5.8]) than newsletter (-5.1 kg [-7.2, -3.0]); p = .01. Modest lipid, glucose, and blood pressure improvements were found, but did not differ significantly between groups. Small SPPB and activity improvements were maintained at 12 and 24 months in both groups. Conclusions Brief phone contacts compared to newsletters enhanced weight loss maintenance among older high-risk adults at 1 year, but not cardiometabolic outcomes. Modest functional improvements were observed in both. Lower-intensity maintenance contacts (phone or newsletter) for weight, health, and physical function in older adults warrant further study. Clinical trials registration number NCT03192475.

The TOPAZ study: a home-based trial of zoledronic acid to prevent fractures in neurodegenerative parkinsonism

Abstract: The Trial of Parkinson's And Zoledronic acid (TOPAZ, https://clinicaltrials.gov/ct2/show/NCT03924414 ) is a unique collaboration between experts in movement disorders and osteoporosis to test the efficacy of zoledronic acid, an FDA-approved parenteral treatment for osteoporosis, for fracture prevention in people with neurodegenerative parkinsonism. Aiming to enroll 3,500 participants age 65 years or older, TOPAZ is one of the largest randomized, placebo-controlled clinical trials ever attempted in parkinsonism. The feasibility of TOPAZ is enhanced by its design as a U.S.- wide home-based trial without geographical limits. Participants receive information from multiple sources, including specialty practices, support groups and websites. Conducting TOPAZ in participants' homes takes advantage of online consent technology, the capacity to confirm diagnosis using telemedicine and the availability of research nursing to provide screening and parenteral therapy in homes. Home-based clinical research may provide an efficient, convenient, less expensive method that opens participation in clinical trials to almost anyone with parkinsonism.

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

Abstract: 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.

Cost-effectiveness of 3 versus 6 years of zoledronic acid treatment before bisphosphonate holiday for women with osteoporosis

Abstract: We evaluated the cost-effectiveness of recurrent periods of 3 versus 6 years of zoledronic acid treatment prior to 3-year bisphosphonate holidays for US postmenopausal women with osteoporosis and femoral neck BMD T-scores between − 2.5 and − 3.5. We found that cycles of 3 years of treatment followed by holidays is likely to be the more cost-effective option. We compared the effectiveness and cost-effectiveness of cycles of 3 years versus 6 years of zoledronic acid treatment prior to 3-year bisphosphonate holidays for US postmenopausal women with osteoporosis. We developed an individual-level state-transition microsimulation cost-effectiveness model to compare treatment strategies over the lifetime of recurrent periods of 3 years of zoledronic acid followed by 3-year holidays (zoledronic acid 3/3), recurrent periods of 6 years of zoledronic acid followed by 3-year holidays (zoledronic acid 6/3), and no zoledronic acid treatment for women with osteoporosis and femoral neck BMD T-scores between − 2.5 and − 3.5. Base-case analysis and all key parameter sensitivity analysis findings for every treatment initiation age evaluated (50, 60, 70, and 80) revealed that zoledronic acid 3/3 was consistently the most cost-effective strategy, assuming a willingness-to-pay of $100,000 per quality-adjusted life-year (QALY). In general, the zoledronic acid 3/3 and 6/3 strategies were relatively close in effectiveness (QALYs) over the lifetime; however, lifetime direct health care costs were on average approximately $2000 lower for the 3/3 strategy. Probabilistic sensitivity analysis results revealed that the zoledronic acid 3/3 strategy was favored in greater than 70% of the iterations for a willingness-to-pay threshold of $100,000/QALY for all treatment initiation ages evaluated. After 3 years of zoledronic acid treatment for postmenopausal women with osteoporosis and femoral neck BMD T-scores between − 2.5 and − 3.5, taking 3-year holidays before restarting another treatment cycle is likely to be more cost-effective over the lifetime than cycles of 6 years of treatment prior to 3-year holidays.

Correction to: How has COVID-19 affected the treatment of osteoporosis? An IOF-NOF-ESCEO global survey

Abstract: A Correction to this paper has been published: https://doi org/10 1007/s00198-021-05905-7 [ABSTRACT FROM AUTHOR] Copyright of Osteoporosis International is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission However, users may print, download, or email articles for individual use This abstract may be abridged No warranty is given about the accuracy of the copy Users should refer to the original published version of the material for the full abstract (Copyright applies to all Abstracts )

Zoledronic acid and bone health in older adults with cognitive impairment.

Abstract: Fracture prevention in cognitively impaired individuals is lacking. This work highlights the benefits of zoledronic acid on bone health in cognitively impaired older adults. Demonstrating benefits of therapy may increase treatment uptake and reduce fracture risk in this group. Osteoporosis has detrimental consequences for frail older adults. The effects on those with both osteoporosis and cognitive impairment are compounded due to increased risk of falls and changes in mobility, both of which can lead to fracture. However, there are limited data on treatment benefits for osteoporotic individuals with cognitive impairment. This post hoc, secondary analysis of data from a randomized, double-blind, placebo-controlled clinical trial of single-dose zoledronic acid included 179 women age ≥ 65 years residing in assisted living facilities or nursing homes, 43 of whom had mild to severe cognitive impairment. We assessed bone mineral density (BMD) of the total hip, femoral neck, and lumbar spine by dual-energy x-ray absorptiometry and serum bone turnover markers (C-terminal telopeptide of type I collagen and procollagen type I N propeptide) at 6 and 12 months. In participants with cognitive impairment, those who received zoledronic acid had 4.3% greater BMD at the total hip (p=.005) and 5.3% greater BMD at the femoral neck (p<.001) after 12 months compared to those in the placebo group. Bone turnover markers demonstrated significant decreases at 6 months in those with cognitive impairment who received active treatment compared to the placebo group. Improvements in bone health measures with zoledronic acid were similar to those seen in participants without cognitive impairment. Zoledronic acid improves bone health in frail older women with cognitive impairment similar to those without impairment. Further studies are warranted to assess the benefit for fracture reduction in this undertreated population.

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

Abstract: 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.