Osteoporosis medication use over time in the United States and Canada.

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Published in final edited form as: Osteoporos Int. 2025 Apr 2;36(6):1089–1094. doi: 10.1007/s00198-025-07484-3 Osteoporosis medication use over time in the United States and Canada Kaleen N Hayes 1, 2, 3 , Andrew R Zullo 1, 2 , Sarah D Berry 4, 5 , Arman Oganisian 6 , Sulbh Aggarwal 3, 7 , Michael Adegboye 1 , Suzanne M Cadarette 3, 7, 8 Author information Article notes Copyright and License information 1 Department of Health Services, Policy, and Practice and Center for Gerontology and Healthcare Research, Brown University School of Public Health, 121 South Main Street, Providence, Rhode Island, USA 2 Department of Epidemiology, Brown University School of Public Health, Providence, RI, USA 3 Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Canada 4 Hinda and Arthur Marcus Institute for Aging Research, Hebrew Seniorlife and Harvard Medical School, Boston, MA, USA 5 Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA 6 Department of Biostatistics, Brown University School of Public Health, Providence, RI, USA 7 ICES, Toronto, ON, Canada 8 Dalla Lana School of Public Health, University of Toronto, Toronto, Canada ✉ Kaleen N. Hayes, Kaley_hayes@brown.edu Issue date 2025 Jun. PMC Copyright notice PMCID: PMC12122215  NIHMSID: NIHMS2072581  PMID: 40169456 The publisher's version of this article is available at Osteoporos Int Abstract Summary Over 12 years in the US and 26 years in Ontario, Canada, we found major differences in osteoporosis medications used. In both countries, osteoporosis medication initiation has not returned to pre-2008 levels; however, denosumab use is increasing. Future work should determine whether targeted screening or undertreatment drives these trends. Purpose Concerns about adverse events caused a rapid decline in osteoporosis medication use globally between 2008 and 2012. Trends in use in recent years have not been described. We aimed to describe and compare trends over time in the initiation and overall use of osteoporosis medications among older adults in the US and Ontario, Canada. Methods We conducted a serial cross-sectional study leveraging two data sources: healthcare administrative data for all older adult residents of Ontario, Canada (ON) and Medicare claims and enrollment data for a 20% random sample of beneficiaries (US). We included community-dwelling older adults aged ≥ 66 years at their first dispensing of an osteoporosis medication between 05/01/1996–12/31/2022 in ON and 01/01/2008–12/31/2020 in the US. We described and compared the number of incident and prevalent users of osteoporosis medications annually. Results We identified 771,025 (average age = 75.2 years; 78% female) individuals in ON and 424,995 (average age = 75.3 years; 85% female) in the US initiating osteoporosis medications. In the US, alendronate and denosumab were the most common therapies, while in ON, risedronate and denosumab were most common. New use of osteoporosis medications dropped more between 2008 and 2011 in the US versus ON (58% vs. 29% relative decrease). Initiation of osteoporosis medications did not rebound to pre-2008 levels. Conclusion New use of osteoporosis medications remains below pre-2008 levels, and differs between the US and Canada. Future research should aim to understand drivers of decreased use, like changes in the screening strategy used for initial treatment or persisting concerns about adverse effects. Keywords: Osteoporosis, Denosumab, Aged patients, Bone density conservation agents, Bisphosphonates, Zoledronic acid Introduction Osteoporosis is a chronic condition that affects 1 in 5 older adults [ 1 ], and most patients require long-term treatment to prevent fractures. Many effective medications exist for the treatment and prevention of osteoporosis, including bisphosphonates, denosumab, and anabolic therapies. Concerns about potential adverse events associated with bisphosphonates, specifically atypical femoral fractures (AFF) and osteonecrosis of the jaw (ONJ), resulted in a drastic decrease in use from 2008–2012 in North America [ 2 ]. It is unclear if use of medications to prevent osteoporotic fractures has rebounded in more recent years since AFF and ONJ were demonstrated to be very rare and new therapies became available, like denosumab which came to market in 2010 [ 3 , 4 ]. Further, a comprehensive understanding of osteoporosis medication patterns is required to inform the design of studies that provide real-world evidence to fill longstanding knowledge gaps on the potential benefits and harms of long-term use. Our objective was to describe and compare trends over time in the initiation and overall use of osteoporosis medications in the US and Ontario, Canada. Materials and methods Data sources We conducted a population-based, serial cross-sectional study leveraging two data sources: 1) US Medicare data for a 20% random sample of beneficiaries (“US data,” representing a source population of approximately 5.6 million adults aged ≥ 65 in a given year); and 2) universal healthcare administrative and enrollment data from Ontario, Canada (“ON data,” representing a population of about 2.5 million adults aged ≥ 65 in a given year). The 20% random sample of Medicare beneficiaries was generated by the Research Data Assistance Center for the Centers for Medicare and Medicaid Services using an annual sampling of Healthcare Insurance Numbers (unique identifiers created by Medicare based on social security numbers) [ 5 ]. Ontario provides universal healthcare for all residents for medical necessary services and procedures [ 6 ]. Prescription medication coverage is provided through the Ontario Drug Benefit (ODB) program to older adults (aged ≥ 65 years), those requiring social assistance, and more recently, those aged ≤ 24 years without alternative coverage. Thus, the Ontario population studied represents all Ontario residents aged 65 years or older. ON data included the Registered Persons Database (demographic information), the ODB database for prescription medication claims, and the Continuing Care Reporting System (CCRS; records transition to/from and residence in long-term care). ON data were linked using unique encoded identifiers and analyzed at ICES. Medicare is a US federal health insurance program that provides coverage to US residents aged ≥ 65 years or older, people with end-stage renal disease, and people younger than age 65 who have certain disabilities [ 7 ]. Medicare is the primary source of healthcare insurance for older adults in the US [ 8 ]. Medicare data sources included the Medicare Beneficiary Summary File (MBSF; enrollment and demographic information), Part B carrier claims (outpatient provider visits, emergency visits, and outpatient medication administrations), Part D claims (prescription medication dispensing claims), and the Residential History File (RHF; combines hospital, skilled nursing facility, and other claims to establish dates for transitions of care and long-term care) [ 9 ]. Study population and exclusions We identified all persons at their first recorded dispensing of an osteoporosis medication (index date) between May 1, 1996 to Dec 1, 2022 for ON data and January 1, 2007 to December 31, 2020 for US data. Eligible osteoporosis medications included oral bisphosphonates (alendronate, risedronate, ibandronate [US only], and etidronate [ON only]), IV bisphosphonates (zoledronic acid), abaloparatide (US only), calcitonin, denosumab, raloxifene, romosozumab, and teriparatide. Medication claims were identified using ODB data for ON and Medicare Part B and Part D claims for US data. We restricted the US data to those with ≥ 12 months of Medicare Parts A, B, and D enrollment (i.e., Fee-for-Service [FFS] beneficiaries) and an index date on or after January 1, 2008 so a minimum of 1-year lookback data was available. We then excluded patients in ON and the US with data errors (e.g., death date before index date), age ≤ 66 years of age at index, use of certain bone-related medications (e.g., zoledronic acid dose for a malignancy-related indication) in the 0 to 365 days prior to the index date, or residence in long-term care on the index date. Long-term care was identified using CCRS and ODB data for ON and the RHF for US data. Claims for all osteoporosis medications after the index date were cleaned by deleting claims after the individual’s date of death or entry into long-term care, as the population of interest for this study was community-dwelling older adults. We defined “any use” of osteoporosis medications (prevalent users) as those with at least one dispensation within a given calendar year. This process was repeated to create “medication-specific” cohorts by identifying persons at their first dispensing of each specific osteoporosis medication and applying the same exclusions as of that date. Thus, individuals could be represented in multiple medication cohorts (e.g., if they initiated alendronate then switched to denosumab), yet only once in the cohort of first-ever osteoporosis medication use. Prevalent users of each osteoporosis medication were defined similarly as those with any osteoporosis medication use, above. Finally, we conducted sex-stratified analyses comparing new use of any osteoporosis medication and new use of denosumab, which had distinct trends in use for males versus females in exploratory analyses. Analysis We described and plotted the number of patients with new (first-ever) use and any use of each osteoporosis medication by calendar year, and summarized age and sex using descriptive statistics. We chose not to conduct formal statistical tests for trends, as these tests are relatively uninformative in large populations since they are directly impacted by sample size and often reject the null hypothesis (i.e., “are significant”), even when differences are trivial [ 10 ]. Instead, we present qualitative comparisons of numbers of persons on therapy and time trends within and between the two study populations. Analyses were performed using SAS version 9.4 (SAS Institute, Cary, US). This study was approved by the Brown University Institutional Review Board, and the requirement for informed consent was waived. We followed the STROBE reporting guidelines for cross-sectional studies [ 11 ]. Results We identified 771,025 (average age = 75.2 [SD = 6.9] years; 78% female) unique individuals in ON and 424,995 (average age = 75.3 [SD = 7.0] years; 85% female) in the US initiating their first osteoporosis medication during the study period. Detailed exclusion diagrams for each data source are available in Figures S1 and S2 . The number of individuals with new (incident) use and any (prevalent) use of osteoporosis medications by calendar year is presented in Figs. 1 and 2 , respectively. In ON, the most common medication used overall was risedronate ( n = 459,832 individuals with any use), followed by alendronate ( n = 310,157), etidronate ( n = 303,584), and denosumab ( n = 192,503). In the US, alendronate was the predominant medication used overall ( n = 339,359 individuals with any use), followed by denosumab ( n = 120,523). Zoledronic acid use was more prevalent in the US versus ON (46,213 vs. 5,352 users). Fig. 1. Open in a new tab Older adults with new use (first use) of osteoporosis medications (Medicare: N = 424,295 unique individuals; Ontario, Canada: 771,025 individuals). Footnote: ABA – abaloparatide; ALD – alendronate; DMAB – denosumab; CCT – calcitonin; ETD – etidronate; IBD – ibandronate; PTH – teriparatide; RAL – raloxifene; RSD – risedronate; ZOL – zoledronic acid. Abaloparatide, ibandronate, romosozumab not available in Ontario; PTH not pictured in Ontario due to very low use in eligible individuals (< 300 unique users). ETD not available in the US; romosozumab initiators not pictured due to very low use in US eligible individuals (< 300 unique users) Fig. 2. Open in a new tab Older adults with any use (first & prevalent) of osteoporosis medications (Medicare: N = 424,295 unique individuals; Ontario, Canada: 771,025 individuals). Footnote: ABA – abaloparatide; ALD – alendronate; DMAB – denosumab; CCT – calcitonin; ETD – etidronate; IBD – ibandronate; PTH – teriparatide; RAL – raloxifene; RSD – risedronate; ZOL – zoledronic acid. Abaloparatide, ibandronate, romosozumab not available in Ontario; PTH not pictured in Ontario due to very low use in ON eligible individuals (< 300 unique users). ETD not available in the US; romosozumab initiators not pictured due to very low use in US eligible individuals (< 300 unique users) General patterns in the number of people initiating osteoporosis medications were similar between ON and the US during the common years of data (2008–2020); however, the decrease in new use of osteoporosis medications seen after 2008 was greater in the US. Specifically, the number of new users of osteoporosis medications in 2008 was n = 55,728 in the US sample and n = 29,647 in ON; new use decreased in both countries thereafter, yet new use in the US dropped more by 2011 than ON (58% vs. 29% relative decrease from 2008 to 2011 in the US vs ON). The number of people initiating osteoporosis medications did not rebound to pre-2008 numbers in either the US or ON, but denosumab use has largely contributed to a steady increase in patients on treatment in both the US and ON in recent years, Fig. 2 . Finally, there was a decrease in new use in 2020 in both countries, though data from 2021–2022 show that the number of new initiators increased after a drop in 2020 in ON. In sex stratified analyses, trends in all new osteoporosis medication use and new denosumab use in females largely mirrored those for the overall study population. For all new osteoporosis medication use ( Figure S3 in the Supplement ), the number of males initiating therapy in the US Medicare sample was stable, with around 4,000–5,000 individuals annually between 2008 and 2020. In ON, the number of males initiating osteoporosis medications increased steadily from 1996 to 2007, then dropped slightly but to a lesser degree than females from 2008–2012 and remained somewhat stable with around 6,000–7,000 males initiating therapy annually from 2013 onwards. Both data sources showed rapid uptake of denosumab overall upon its entry to market in 2010 in the US and 2012 in ON ( Figure S4 in the Supplement ), primarily driven by use in females. Denosumab initiation in males in the US was relatively low and stable throughout the study period (average 1,933 initiators annually between 2012 and 2020). Conversely, use of denosumab in males was low in ON until it was added to the ODB formulary for males in 2018; thereafter, uptake rapidly increased, from 388 males initiating denosumab in 2017 to 4,759 males initiating in 2018. Discussion In this cross-sectional study of more than one million older adults treated for osteoporosis over a period of 12 years in the US and 26 years on Ontario, we identified major changes in the number of individuals treated and the type of osteoporosis medications prescribed over time. We identified a large decline in new treatment with osteoporosis medications after 2008 as anticipated based on prior literature [ 2 , 12 ]. The greater decline in osteoporosis medication use in the US vs. Canada after 2008 is likely the result of more direct access to negative media coverage on bisphosphonates [ 2 ]. Increasing implementation of drug holidays may have also contributed to decreases in prevalent use of bisphosphonates in this period [ 12 , 13 ]. New use of osteoporosis drugs did not rebound in recent years despite evidence on the extreme rarity of adverse effects of bisphosphonates relative to typical osteoporotic fractures, better understanding of the risk factors for adverse effects, and the availability of new osteoporosis medications. Another drop in use was observed in both the US and Ontario in 2020 at the onset of the COVID-19 pandemic, though ON data demonstrated a recovery to above 2019 numbers in 2022, consistent with time series analysis that focused on the timeliness of denosumab dispensations in Ontario [ 14 ]. Lower treatment rates may reflect a shift in strategy to determine when to start pharmacotherapy. Earlier decision-rules for initiating osteoporosis therapy largely focused on bone mineral density (BMD) testing alone, but later emphasized estimating a patient’s 10-year risk of fracture (e.g., using the Fracture Risk Assessment Tool [ 15 ], or FRAX, launched in 2008) which considers BMD as only one of several risk factors. Further, in later years, clinicians likely began to differently weigh the risk/benefit tradeoff of starting therapy earlier versus later given the lack of evidence on the best long-term osteoporosis treatment strategy. Similarly, therapy for prevention of osteoporosis (e.g., alendronate 5 mg daily formulation) has also likely declined. Finally, decreased numbers may partly reflect a “depletion in susceptibles,” i.e., fewer patients eligible in general to initiate medications for osteoporosis given the large amount of initial use in early years. Indeed, we note that the decline in new initiators in Ontario began after a peak in 2001 – well before harms of long-term bisphosphonate use started to emerge. Some differences in the type of medications used were observed between the US and Ontario. For example, alendronate was the predominant osteoporosis medication in the US, whereas risedronate was most common in Ontario, potentially due to targeted marketing of risedronate in Canada [ 12 ]. Etidronate was the predominant therapy used in Ontario prior to broadened coverage under the ODB public plan for alendronate and risedronate [ 12 , 16 ]. Etidronate was produced by the same manufacturer as risedronate, which may have contributed to targeted efforts to maintain market share in bisphosphonate use with risedronate after etidronate fell out of favor due to its inferior effectiveness for nonvertebral fracture prevention [ 17 ]. However, the increase in initiation of osteoporosis medications since 2010 in the US and 2012 in Ontario can be attributed in large part to an increase in denosumab therapy, a more convenient alternative to oral bisphosphonates as it is administered every 6 months. More recently it has been demonstrated that denosumab discontinuation results in rapid bone loss and an increased risk of multiple vertebral fractures [ 18 ]. This risk appears to increase with longer duration of denosumab therapy [ 18 ]. Given the large numbers of patients exposed to denosumab treatment per this study and the evidence that healthcare disruptions result in missed doses of denosumab [ 14 ], evidence on how to safely transition patients off denosumab therapy when needed is a critical focus for future research. To our knowledge, this is the first population-based study to describe and compare osteoporosis medication use in the US since the start of the US Medicare Part D Program [ 19 ] and the entirety of availability of modern osteoporosis medications in Ontario. Among over one million older adults, we identified major shifts in osteoporosis medication use and distinct patterns in both the US and Ontario– Canada’s largest province. These differential patterns in osteoporosis medications (e.g., more males exposed to denosumab in Ontario) can be leveraged to provide more definitive and robust evidence to guide osteoporosis treatment decisions, both for initial therapy and long-term treatment. Our study has limitations. First, our data sources were limited to US Medicare Fee-for-Service claims and Ontario healthcare administrative data. We were therefore unable to study osteoporosis medication use in Medicare Advantage beneficiaries, older adults in Canadian provinces outside of Ontario, or patients who paid out of pocket or through private insurance, who may have different patterns of treatment. However, private insurance in Ontario defaults first to the public drug plan. We were also unable to estimate the rate of osteoporosis medication use among the total number of older adults eligible for treatment with the administrative data available, as calculating a valid denominator of persons eligible for osteoporosis treatment is challenging due to the poor sensitivity of diagnostic codes, which identify only about 32% of women with osteoporosis [ 20 ]. Although those with prior fracture might also be considered an important subset eligible for treatment, many patients start treatment prior to fracture. Further, a simple denominator of persons aged 66 years or older (e.g., using census data) is too crude to capture numbers “at risk” given different guidelines for initiating osteoporosis treatment over time in the US vs. Canada. While these limitations precluded our ability to make direct comparisons between rates of treatment in the US and Ontario cohorts, the comparisons of trends within and between cohorts are still valid. Finally, at the time of this research, we did not have access to Medicare data beyond 2020. Future research may investigate trends beyond the onset of the COVID-19 pandemic to determine if use of osteoporosis medications rebounded in the US as we observed in Ontario in 2021–2022. In conclusion, we observed large variation in the number of patients being treated with osteoporosis medications over the past three decades in both the US and Canada. Major differences were observed in which osteoporosis medications were most commonly initiated, but denosumab use continued to increase in both countries despite concerns about rebound fractures after discontinuation. Overall, findings show that after an initial decrease in initiation between 2008 and 2011, there has been a gradual increase in use over time. Future research should examine whether the sustained lower prevalence of initiation of osteoporosis medications despite an aging population is a result of different osteoporosis screening methods or undertreatment of osteoporosis. Supplementary Material supplemental material NIHMS2072581-supplement-supplemental_material.docx (618.6KB, docx) Funding This research was supported by the National Institutes of Health (NIH) Research Grant R01AG078759 funded by the National Institute on Aging (NIA), the NIH Office of the Director, and the NIH Office of Disease Prevention (ODP); and ICES, which is funded by an annual grant from the Ontario Ministry of Health (MOH) and the Ministry of Long-Term Care (MLTC). Ontario analyses were completed at ICES University of Toronto with support from the Leslie Dan Faculty of Pharmacy. The Ontario study used material based on data and/or information compiled and provided by CIHI and the Ontario MOH. We also thank IQVIA Solutions Canada Inc. for use of their Drug Information File. Dr. Zullo is also supported by NIA grants R01AG065722 and R01AG077620. The analyses, conclusions, opinions and statements expressed herein are solely those of the authors and do not reflect those of the funding or data sources; no endorsement is intended or should be inferred. Footnotes Declarations Conflict of interest KNH has received investigator-initiated grant funding paid directly to Brown University for investigator-initiated research from Sanofi, Genentech, and GlaxoSmithKline for research on influenza vaccination in nursing homes, influenza outbreak control, and shingles vaccination in nursing homes, respectively. KNH has also served as a consultant for Canada’s Drug Agency (formerly the Canadian Agency for Drugs and Technologies in Health) for the development of reporting guidance for real-world evidence. ARZ has received grant funding paid directly to Brown University by Sanofi for collaborative research on the epidemiology of infections and vaccinations among nursing home residents and infants. 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