SUN-806 - Representation in Osteoporosis Medication Clinical Trials: A Perspective from the FNIH-ASBMR-SABRE Cohort

Introduction
Osteoporosis is common and associated with high post-fracture morbidity and mortality. As the global population ages, osteoporosis prevalence is increasing across all demographic groups; however, there are known differences in bone mineral density (BMD), osteoporosis prevalence, fracture risk, and post-fracture outcomes by age, sex, and race and ethnicity. Osteoporosis clinical trials may not include demographically representative populations to study drug efficacy.
Methods
We leveraged the FNIH-ASBMR-SABRE database, the largest compilation of osteoporosis pharmacotherapy clinical trial data to date. Randomized, placebo-controlled trials of approved osteoporosis medications were included, as well as trials of drugs for which approval was not sought or received. Small studies, those targeting specific medical conditions (e.g., glucocorticoid-induced osteoporosis), and those without longitudinal hip BMD information and fracture as primary outcomes were excluded. Among these osteoporosis pharmacotherapy trials, we examined the representation of Black participants overall and by drug class and used time-trend regression analysis to determine if the proportion of Black participants included in trials increased over time. Race and ethnicity were assigned as categorized in each clinical trial repository.
Results
Of 24 trials published between 1995 - 2019 and including 132,399 participants, 17 (71%) trials included ≤1.0% Black participants, and only 3 (13%) included ≥ 5% Black participants. Of the total 3,832 Black participants (2.9%) in the FNIH-ASBMR-SABRE database, 2,738 (71% of all Black participants) participated in a single study (Women’s Health Initiative trial of hormone replacement), with the remaining 29% (n=1,094) across the other 22 trials. Black participants comprised < 1% of participants in trials of bisphosphonates, the most prescribed class of osteoporosis pharmacotherapy. Over the 24-year period of trial publication, there was no significant change over time in inclusion of Black individuals (p for trend=0.28).
Conclusion
Black individuals are significantly underrepresented in osteoporosis clinical trials, representing fewer than 3% of total participants, with significantly lower rates among the most used therapies (e.g., bisphosphonates). Current use of osteoporosis medications in Black men and women is based on the unproven presumption of homogeneity of treatment effect across populations. To facilitate informed shared decision-making when treating Black individuals, clinicians should discuss the limitations of our knowledge of osteoporosis therapeutic efficacy in Black individuals. Future osteoporosis clinical trials should actively seek to improve representation of racially and ethnically diverse participants to ensure generalizability across demographic populations.

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