# Adding bone microarchitecture and strength measures to the STRONG BONES randomized trial examining risedronate use to mitigate bone loss after bariatric surgery

> **NIH NIH R01** · WAKE FOREST UNIVERSITY HEALTH SCIENCES · 2024 · $427,507

## Abstract

PROJECT SUMMARY
Bariatric surgery is increasingly used to treat severe obesity and related comorbidities. However, clinical practice
guidelines now recognize associated skeletal consequences, as mounting evidence implicates surgical weight
loss in the onset of skeletal fragility. To address this, the randomized controlled trial, Strategies to Reduce the
Onset of Sleeve Gastrectomy Associated Bone Loss (STRONG BONES; U01AR080969) is testing if the
bisphosphonate, risedronate (a first-line osteoporosis drug), can effectively counter bone loss secondary to the
most common bariatric surgical procedure, sleeve gastrectomy (SG). This trial is randomizing 120 SG patients
(ages≥40) to 6 months of risedronate or placebo treatment, and assessing skeletal changes via dual energy x-
ray absorptiometry (DXA), computed tomography (CT), and blood-based biomarkers at baseline, 6, and 12
months; yet, these modalities are not sufficient to measure bone microstructure changes that are expected with
surgical weight loss and bisphosphonate treatment. The proposed ancillary study leverages the patient cohort,
infrastructure, and data of the parent STRONG BONES trial, and enhances its scientific value by adding high-
resolution peripheral quantitative computed tomography (HRpQCT) imaging to assess interventional effects on
bone microarchitecture, density, and strength of the tibia and radius. HRpQCT is the only in vivo image modality
with sufficient resolution (61µm) to assess trabecular and cortical microarchitecture. Using longitudinal HRpQCT
imaging and micro-finite element (microFE) analysis of bone strength, we can pinpoint local areas of dynamic
bone formation or resorption and examine the mechanoregulation of this bone remodeling. The ancillary study
will add HRpQCT measures of the STRONG BONES participants, with four HRpQCT scans (distal tibia and radius;
diaphyseal tibia and radius) per visit (baseline, 6 and 12 months). Building on the parent trial, this ancillary study
is a timely, efficient, and cost-effective means to definitively test the scientific premise that risedronate can
attenuate deterioration of bone microarchitecture, density, and strength secondary to SG. Specific Aims are to:
(1) Determine the effect of risedronate vs. placebo on 12-month change in microFE-derived bone strength (failure
load) of the tibia and radius following SG. (2) Determine the effect of risedronate following SG on 12-month
change in HRpQCT-acquired trabecular and cortical bone mineral density and microarchitecture (e.g., trabecular
number, spacing; cortex thickness, porosity). (3) Investigate the localized remodeling and mechanoregulation of
bone in the microenvironment, and the associations of HRpQCT metrics with other skeletal outcomes obtained
in the parent study [DXA, CT, and bone turnover/tissue-crosstalk biomarkers] to elucidate biological mechanisms
underlying SG-associated bone loss and potential counteractant effects of risedronate. Definitive data supporting
use ...

## Key facts

- **NIH application ID:** 10823080
- **Project number:** 1R01AR083706-01
- **Recipient organization:** WAKE FOREST UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** Ashley Weaver
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $427,507
- **Award type:** 1
- **Project period:** 2024-02-23 → 2028-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10823080

## Citation

> US National Institutes of Health, RePORTER application 10823080, Adding bone microarchitecture and strength measures to the STRONG BONES randomized trial examining risedronate use to mitigate bone loss after bariatric surgery (1R01AR083706-01). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10823080. Licensed CC0.

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