Publications | SABRE Bone

SABRE Publications

Treatment-related changes in bone mineral density as a surrogate biomarker for fracture risk reduction: meta-regression analyses of individual patient data from multiple randomised controlled trials

This meta-analysis of individual patient data from multiple randomized controlled trials demonstrated that treatment-related increases in bone mineral density strongly predict reductions in vertebral, hip, and nonvertebral fracture risk, supporting bone mineral density as a valid surrogate endpoint for osteoporosis treatment efficacy

BLACK DM, BAUER DC, et al. LANCET DIABETES ENDOCRINOL. 2020 AUG;8(8):672-682. PMID: 32707115.

Change in Bone Density and Reduction in Fracture Risk: A Meta-Regression of Published Trials

The study evaluated whether increases in bone mineral density (BMD) during osteoporosis treatment are associated with reductions in fracture risk by analyzing data from multiple published clinical trials.

bouxsein ml, eastell r, et al. j bone miner res. 2019 apr;34(4):632-642. pmid: 30674078

Validation of the Surrogate Threshold Effect for Change in Bone Mineral Density as a Surrogate Endpoint for Fracture Outcomes: The FNIH-ASBMR SABRE Project

This study validated threshold levels of treatment-related bone mineral density gains that reliably predict fracture risk reduction, further supporting bone mineral density change as a surrogate endpoint for assessing osteoporosis treatment efficacy in clinical trials.

Eastell r, vittinghoff e, et al. j bone miner res. 2022 jan;37(1):29-35. pmid: 34490915

Diabetes Mellitus and the Benefit of Antiresorptive Therapy on Fracture Risk

This study found that patients with diabetes mellitus experienced fracture risk reductions from antiresorptive osteoporosis therapies comparable to those without diabetes, supporting the effectiveness of these treatments in diabetic populations

Eastell r, vittinghoff e, et al. j bone miner res. 2022 nov;37(11):2121-2131. pmid: 36065588

Influence of age on the efficacy of pharmacologic treatments on fracture risk reduction and increases in BMD: RCT results from the FNIH-ASBMR-SABRE project

This pooled analysis from the FNIH-ASBMR-SABRE project found that osteoporosis medications reduced fracture risk and increased bone mineral density similarly across age groups, supporting the effectiveness of pharmacologic osteoporosis treatment even in older adults.

schini m, vilaca t, et al. J Bone Miner Res. 2024 May 24;39(5):544-550. PMID: 38501786.

Pre-treatment bone mineral density and the benefit of pharmacologic treatment on fracture risk and BMD change: analysis from the FNIH-ASBMR SABRE project

This FNIH-ASBMR SABRE project analysis found that osteoporosis medications reduced fracture risk regardless of patients’ baseline bone mineral density, indicating that individuals with both low and higher pre-treatment BMD can benefit from pharmacologic osteoporosis therapy.

schini m, vilaca t, et al. J Bone Miner Res. 2024 aug 5;39(7):867-876. PMID: 38691441.

The relationship between treatment-related changes in total hip BMD measured after 12, 18, and 24 mo and fracture risk reduction in osteoporosis clinical trials: the FNIH-ASBMR-SABRE project

This FNIH-ASBMR SABRE project analysis demonstrated that treatment-related increases in total hip bone mineral density measured as early as 12 months were associated with reduced fracture risk, with stronger predictive relationships observed at 18 and 24 months, supporting bone mineral density change as an early surrogate endpoint for osteoporosis treatment efficacy.

vilaca t, schini m, et al. J Bone Miner Res. 2024 sep 26;39(10):1434-1442. PMID: 39127916.

Treatment-related changes in total hip bone mineral density are applicable to trials of varied study designs and to drugs with differing mechanisms of action: meta-regression results from the FNIH-ASBMR SABRE study

This FNIH-ASBMR SABRE meta-regression analysis demonstrated that treatment-related increases in total hip bone mineral density consistently predict fracture risk reduction across different osteoporosis drug mechanisms and clinical trial designs, supporting the use of BMD change as a robust surrogate endpoint in osteoporosis trials.

vilaca t, lui ly, et al. J Bone Miner Res. 2025 oct 28;40(11):1228-1237. PMID: 40720735.