Bone and Mineral Metabolism

SAT-800 - Association between the Treatment-Related Change in Bone Mineral Density and Fracture Risk Reduction According to the Pre-Treatment BMD: Analysis from the FNIH-ASBMR SABRE Project

Saturday, June 13, 2026

9:30 AM - 4:30 PM CT

Location: ENDOExpo; Poster Floor

Abstract Poster Presenter(s)

MARIAN SCHINI, MD, PhD (she/her/hers)

UNIVERSITY OF SHEFFIELD
Sheffield, United Kingdom

Co-Author(s)

LL

Li-Yung Lui, n/a

California Pacific Medical Center
San Francisco, California, United States
TV

Tatiane Vilaca, MD, PhD

University of Sheffield
Sheffield, United Kingdom
SE

Susan K. Ewing, M.S.

Statistician
University of California San Francisco
San Francisco, California, United States
AT

Austin R. Thompson, MPH

University of California, San Francisco
San Francisco, California, United States
BL

B Langdahl

Aarhus University Hospital, United States
DB

Dennis M. Black, PhD

University of California-San Francisco, United States
MB

Mary L. Bouxsein, PhD (she/her/hers)

Professor
HARVARD MEDICAL SCHOOL / BIDMC
Boston, Massachusetts, United States

Senior Author/Primary Investigator(s)

RE

Richard Eastell, MD

Professor of Bone Metabolism
University of Sheffield
Sheffield, United Kingdom

Disclosure(s):

MARIAN SCHINI, MD, PhD: Kyowa Kirin International: Honorarium Recipient (); Medical Research Council Versus Arthritis Centre for Integrated Research into Musculoskeletal Ageing: Funding for fellowship (); Osteoporosis 2000 Charity: Funding for fellowship (); Roche Diagnostics: Grant Recipient (); UCB: Honorarium Recipient ()

Introduction
In December 2025, the FDA qualified the use of total hip BMD (TH BMD) as a surrogate endpoint for future trials of anti-osteoporosis therapies. This was based on analyses and evidence from the FNIH-ASBMR SABRE (Study to Advance BMD as a Regulatory Endpoint) project. However, if future trials do not have to demonstrate anti-fracture efficacy, they may enrol lower-risk subjects. Thus, it is essential to determine whether baseline BMD levels affect the relationship between changes in TH BMD and fracture risk reduction.

Methods
Using the SABRE database, we separated participants into those with a TH BMD T-score ≤ -2.5 and those with a TH BMD T-score> -2.5. We performed trial-level meta-regressions comparing the association between the 24-month between-treatment difference in TH BMD per cent change and clinical fracture risk reduction across baseline TH BMD T-score subgroups. We calculated the r2 (95% CI) for each group. The clinical fracture category was defined as non-vertebral + clinical vertebral fractures.

Results
Data from 15 trials were included in the meta-regression. There were 20,474 participants in the T-score ≤ -2.5 group and 54,196 in the T-score > -2.5 group. The meta-regression results were similar across groups, with r2 (95% CI) for the T-score ≤ -2.5 group of 0.49 (0.08 to 0.70), p = 0.004, and for the T-score > -2.5 group, r2 = 0.39 (0.02 to 0.64), p = 0.01. The p-value for the r2 interaction term was 0.66.

Discussion
Notably, the range of BMD per cent change was greater in the low-BMD group. This was because the results were expressed as a percentage; however, the absolute changes in BMD were similar. The higher BMD group had more trials from less potent medications.

Conclusion
These findings suggest that, in future trials of new osteoporosis treatments where efficacy will be judged by total hip BMD change, participants can be included independently of their baseline total hip T-score, as the association between bone mineral density per cent change and fracture risk reduction is similar.

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