# Addressing knowledge gaps by multi-level research design to optimize clinical trial development in order to reduce fracture burden for adults with neurodevelopmental disabilities

> **NIH NIH R01** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2021 · $240,240

## Abstract

PROJECT SUMMARY
Individuals with neurodevelopmental disabilities (NDDs) have unmet healthcare needs and heightened
susceptibility for skeletal fragility and non-trauma fracture (NTFx) throughout their lifespan, resulting in greater
risk for early development of chronic diseases and early mortality. There is a fundamental gap in the
understanding of skeletal pathology, burden of NTFx, and clinical care needed to prevent and manage skeletal
fragility for these vulnerable adult populations. Continued existence of this gap represents a major public health
issue because the adult population with NDDs is growing, and poorly managed healthcare could lead to a
disproportionate rise in the disease burden attributable to adults with NDDs. The long-term goal is to identify
and address unmet healthcare needs to improve healthful aging for individuals with NDDs. The objective of this
multi-level study is to address fundamental knowledge gaps in order to improve clinical care for skeletal fragility
and to optimize clinical trial design to reduce the NTFx burden for adults with NDDs. Aim 1 will identify risk
factors for NTFx and determine the post-NTFx burden of diseases and mortality among a large, heterogeneous
sample of adults with and without NDDs by leveraging nationwide private and public administrative claims data
from 2012-2019. This information will be used to inform intervention strategies and determine important health-
related outcome measures to be used as benchmarks of success for future clinical trials. Aim 2 will determine
causes of NTFx among a clinical sample of adults with NDDs by leveraging electronic medical records. This
information will be used to inform intervention strategies for future clinical trials. In Aim 3, mixed methods will
be used to develop and then administer a survey to gauge patient awareness on the importance of NTFx
prevention on their overall health and function, willingness to participate in NTFx prevention programs (e.g.,
clinical trial), and barriers and facilitators that may impact clinical trial participation. This information will be
used to identify obstacles, opportunities, and solutions to design successful clinical trials to reduce the burden
of NTFx specific to the needs of these complex patient groups. The research is clinically innovative because it
will challenge the current paradigm regarding NTFx assessment and evaluation, which is typically focused on
older adults and postmenopausal women. The research is also innovative because of the use of a
complementary, multi-level research design for information gathering across national, clinic, and patient levels
to optimize clinical care and clinical trial design. The research is significant because it is expected to improve
clinical care, increase public health awareness about the burden of skeletal fragility, and optimize clinical trial
design to reduce the NTFx burden for these underserved populations. The purpose of this research is aligned
with the purpose...

## Key facts

- **NIH application ID:** 10101736
- **Project number:** 1R01AR076994-01A1
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** Daniel Whitney
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $240,240
- **Award type:** 1
- **Project period:** 2021-09-23 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10101736

## Citation

> US National Institutes of Health, RePORTER application 10101736, Addressing knowledge gaps by multi-level research design to optimize clinical trial development in order to reduce fracture burden for adults with neurodevelopmental disabilities (1R01AR076994-01A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10101736. Licensed CC0.

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