# Coordination of Consortium Activities for RFA-AG-22-018

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2024 · $74,598

## Abstract

Project Summary
Use of bisphosphonate (BP) medications for the prevention of fractures is declining, partially due to patient and
provider fears about the occurrence of atypical femur fractures (AFF), which are clearly associated with long-
term bisphosphonate use. Many individuals are choosing to not use these medications at all rather than risk
having this rare outcome. This decision may leave individuals at high risk of morbidity and mortality. Balancing
the risk of typical osteoporosis-related fractures, such as hip or vertebral fractures, with the risk of the much
rarer AFF, is an important component of decision-making by physicians and patients about medication use.
Thus, the RFA issued by NIA and NIAMS solicited applications for secondary analyses of existing datasets to
provide evidence about appropriate strategies for long-term osteoporosis therapies, including drug holidays,
and to better understand their risks and benefits (RFA-AG-22-018). Our parent grant will address these issues
by combining individual-level data from three large, population-based cohort studies with radiographically
verified AFFs, comprehensive longitudinal medication exposure, data harmonized definitions of other
covariables, and centrally coordinated statistical programming; this project focuses on 1) examining the risks of
long-term use of BP for the prevention of AFF by determining the independent effects of BP treatment and
drug holidays on AFF risk, including the potential interplay between pre-holiday duration of treatment and
duration of holiday and 2) developing and validating predictive models incorporating patterns of long-term BP
treatment, drug holidays and clinical risk factors, to comprehensively model the expected fracture protection
and potential harms for individual patients and evaluate the group-level balance between AFF risk and
osteoporosis-related fracture prevention. Three other projects with diverse sets of aims and methodologies
using combinations of claims and electronic health records data were also funded to advance the research
program. This administrative supplement is aimed to support the coordination and collaboration of a
consortium consisting of the four R01-funded projects that are leveraging existing large databases and cohorts
to better understand the risks and benefits of long-term osteoporosis therapy and drug holiday.

## Key facts

- **NIH application ID:** 11003476
- **Project number:** 3R01AR082562-03S1
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Annette L Adams
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $74,598
- **Award type:** 3
- **Project period:** 2022-09-19 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11003476

## Citation

> US National Institutes of Health, RePORTER application 11003476, Coordination of Consortium Activities for RFA-AG-22-018 (3R01AR082562-03S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/11003476. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*