# DDT-BMQ-000054: Planning for biomarker qualification, implementation and dissemination for BMD as a surrogate biomarker in future osteoporosis treatment trials: the SABRE project

> **NIH FDA U01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2024 · $250,000

## Abstract

PROJECT SUMMARY
Currently approved therapies for osteoporosis can reduce spine fracture risk by 50-75% and hip fracture risk
by up to 50%. However, due to fears about very rare side effects, use of osteoporosis medications has
declined by 50% since 2008. Therefore, there is a strong need for new therapies that have a strong safety
profile, perhaps with greater efficacy and convenience for the patient. However, new trials require fracture
endpoints and must be very large: as long as 5 years with > 16,000 patients making the development of new
medications extremely expensive and no longer feasible.
The FNIH-ASBMR-SABRE (Study to Advanced BMD as a Regulatory Endpoint) began in 2013 with a primary
goal of qualifying the treatment-related change in bone mineral density (BMD) as a surrogate endpoint in future
trials of new anti-osteoporosis therapies. Successful completion of this goal would prompt innovation and
facilitate new drug development. To this end, we have collected individual patient data from >150,000 patients
in >50 randomized trials and used this unique resource to perform analyses to determine a strong relationship
between larger BMD increase and greater fracture reductions in those trials.
Starting in 2016, we began work with the FDA to obtain formal qualification of change in BMD as a surrogate
endpoint for fracture in future trials. To date, our Letter of Intent and Qualification Plan have been approved by
the FDA and we submitted our Final Qualification Package in August 2023. FDA issued a Reviewability
Memorandum in March 2024, agreeing to complete review by January 2025.
The current proposal will fund our continued work on this project including responding to any questions during
or following the review. If approved, change in BMD would be the first surrogate biomarker qualified by FDA.
Therefore, as part of this proposal, we will also address a number of unique questions regarding the practical
implementation of this, the first FDA qualified, surrogate biomarker.
For this project, we expect to be meeting with FDA to respond to the suggestions in the review of the FQP and
after to advise on the implementation of this surrogate.
The qualification of BMD change as a surrogate endpoint for fracture in future trials of antiosteoporosis
therapies would be a breakthrough in the field that would lead to expedited development of new medications
and enormous benefits for osteoporosis patients and public health.

## Key facts

- **NIH application ID:** 11087988
- **Project number:** 1U01FD008422-01
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Dennis M Black
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2024
- **Award amount:** $250,000
- **Award type:** 1
- **Project period:** 2024-09-01 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11087988

## Citation

> US National Institutes of Health, RePORTER application 11087988, DDT-BMQ-000054: Planning for biomarker qualification, implementation and dissemination for BMD as a surrogate biomarker in future osteoporosis treatment trials: the SABRE project (1U01FD008422-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11087988. Licensed CC0.

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