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Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery

Award Number: U01AR080969
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/20/2022
PERIOD OF PERFORMANCE END DATE: 04/30/2028

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Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery - PROJECT SUMMARY Despite well recognized improvements in obesity-related comorbidities, mounting evidence implicates sleeve gastrectomy (SG) in the onset of skeletal fragility. Bisphosphonate therapy reduces osteoporotic fracture risk and may also be effective in minimizing bone loss associated with SG. Once-monthly oral risedronate is a commonly prescribed bisphosphonate with a favorable gastrointestinal profile that acts by inhibiting the activity of osteoclast cells, thereby decreasing the rate of bone resorption. Because SG is associated with a significant increase in bone resorption, we hypothesize that risedronate use will counter bone loss in this clinical scenario, ultimately reducing long-term fracture risk. Indeed, pilot data from our group signal that six months of risedronate use is both feasible and likely effective at reducing bone resorption and bone mineral density (BMD) loss post- SG as compared to placebo. Intriguingly, we also observe a signal for appendicular lean mass preservation with risedronate use. This novel finding aligns with data from animal models of clinical pathology and limited observational data in humans, suggestive of a bisphosphonate-induced lean-mass sparing effect. If true, confirmatory data from a definitively designed trial is poised to influence clinical management of the SG patient, while also providing a platform upon which to interrogate mechanisms of bone-muscle crosstalk. To fill these knowledge gaps, the main objective of the proposed study is to definitively test whether risedronate use can effectively counter SG associated bone loss. To do this, we propose to randomize 120 middle-aged and older (≥40 years) SG patients to six months of risedronate or placebo treatment, with bone and muscle outcomes assessed at baseline, six, and 12 months. Due to its robust change following SG and clinical utility in predicting fracture, our primary outcome is change in total hip areal (a)BMD measured by dual energy x-ray absorptiometry (DXA). This will be complemented by DXA-acquired aBMD assessment at other skeletal sites and appendicular lean mass, as well as quantitative computed tomography (QCT) derived changes in bone (volumetric BMD, cortical thickness, and strength) and muscle (cross sectional area, fat infiltration) at the hip and spine — allowing for novel assessment of intervention effectiveness on several state of the art bioimaging metrics — as well as select physical function tasks. Biomarkers of bone turnover and bone-muscle crosstalk will also be assessed in a tertiary aim, providing mechanistic insight into intervention-related changes to the bone-muscle unit. Definitive data has the potential to shift current clinical practice while also offering insight into underlying biologic mechanisms.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	WAKE FOREST UNIVERSITY	1834 WAKE FOREST RD	WINSTON SALEM	NC	27109	FORSYTH	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	2/12/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $563,850 )
2025	2025	WAKE FOREST UNIVERSITY	1834 WAKE FOREST RD	WINSTON SALEM	NC	27109	FORSYTH	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	3	4/17/2025	NON-COMPETING CONTINUATION	$563,850
2025	2023	WAKE FOREST UNIVERSITY	1834 WAKE FOREST RD	WINSTON SALEM	NC	27109	FORSYTH	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	11/14/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $563,850

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	WAKE FOREST UNIVERSITY	1834 WAKE FOREST RD	WINSTON SALEM	NC	27109	FORSYTH	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	4/24/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $644,282 )
2023	2023	WAKE FOREST UNIVERSITY	1834 WAKE FOREST RD	WINSTON SALEM	NC	27109	FORSYTH	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	4/25/2023	NON-COMPETING CONTINUATION	$644,282
														Subtotal = $644,282

Issue Date FY: 2022 ( Subtotal = $660,777 )
2022	2022	WAKE FOREST UNIVERSITY	1834 WAKE FOREST RD	WINSTON SALEM	NC	27109	FORSYTH	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	5/19/2022	NEW	$660,777
														Subtotal = $660,777

Grand Total All Awards = $1,868,909

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Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery

Award Number: U01AR080969

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/20/2022

PERIOD OF PERFORMANCE END DATE: 04/30/2028

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