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The Mechanistic Effects of Combined Testosterone Therapy and Exercise on Axial Bone and Muscle Post-Hip Fracture

Award Number: R01AR075346
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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The Mechanistic Effects of Combined Testosterone Therapy and Exercise on Axial Bone and Muscle Post-Hip Fracture - Project Summary/Abstract Osteoporotic fractures have substantial public health impact and better approaches are needed to maximize the functional recovery from hip fracture. This ancillary study will build upon a funded parent trial of exercise and testosterone in 3 groups of women recovering from hip fracture: controls, exercise + placebo (Ex+Pl), or exercise+ testosterone (Ex+T). The parent study goal is to investigate the use of an anabolic hormone to enhance functional recovery beyond exercise interventions. The objective of this study is to investigate the anabolic responses of low-dose transdermal testosterone on the skeleton and muscle in older women recovering from hip fracture, by adding mechanistic assessment of volumetric bone mineral density, muscle area and density as well as measures of testosterone and downstream metabolites in the androgen pathway and the follistatin/activin pathway. The central hypothesis is that exercise and testosterone will increase skeletal strength, muscle area and muscle density to a greater extent than either Ex+Pl or a Control group; also that the magnitude of these changes will be related to the magnitude of change in specific sex steroid concentrations and also increases in follistatin, which is up-regulated by testosterone binding to the androgen receptor. This is a unique, time-sensitive opportunity, as initiation of the additional imaging and serum collection is required to address our aims. Our study aims will compare in three groups of women with recent hip fracture (controls, Ex+Pl, and Ex+T), the 6-month changes in important QCT derived bone and muscle outcomes (volumetric trabecular and cortical bone mineral density, volumetric integral bone mineral density, and vertebral strength using finite element analysis of the spine, as well as paraspinal muscle area and muscle density). Most importantly, the study will also determine the relative contributions of 6-month changes in testosterone, free testosterone, dihydrotestosterone (DHT), follistatin, and estradiol to concomitant changes in the bone and muscle outcomes. Compared to Ex+Pl or to a control group, an Exercise with Testosterone regimen is hypothesized to produce significantly greater improvements in the bone and muscle outcomes. Further, the 6-month changes are hypothesized to be directly associated with increases in free testosterone, the combined levels of circulating testosterone + DHT, and increases in follistatin, but not with changes in estradiol. This project will robustly enhance the scientific content and value of the parent study, leveraging resources to improve understanding of the pathways involved in bone and muscle responses to hormonal and exercise interventions post-hip fracture. Outcomes from this project are likely to identify novel targets for therapeutic interventions, fracture prevention and provide useful surrogate markers of clinical outcomes of hip fracture.


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: 2025 ( Subtotal = -$35,891 )
2025	2023	HEBREW REHABILITATION CENTER	1200 CENTRE ST	ROSLINDALE	MA	02131	SUFFOLK	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	1/7/2025	NON-COMPETING CONTINUATION	-$35,891
														Subtotal = -$35,891

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	HEBREW REHABILITATION CENTER	1200 CENTRE ST	ROSLINDALE	MA	02131	SUFFOLK	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	6/13/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $387,858 )
2023	2023	HEBREW REHABILITATION CENTER	1200 CENTRE ST	ROSLINDALE	MA	02131	SUFFOLK	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	8/7/2023	NON-COMPETING CONTINUATION	$387,858
														Subtotal = $387,858

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	HEBREW REHABILITATION CENTER FOR AGED, INC.	1200 CENTRE ST	BOSTON	MA	02131	SUFFOLK	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	8/5/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $402,456 )
2021	2021	HEBREW REHABILITATION CENTER FOR AGED, INC.	1200 CENTRE ST	BOSTON	MA	02131	SUFFOLK	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	2	7/22/2021	NON-COMPETING CONTINUATION	$402,456
2021	2019	HEBREW REHABILITATION CENTER FOR AGED, INC.	1200 CENTRE ST	BOSTON	MA	02131	SUFFOLK	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	3/24/2021	NEW	$0
														Subtotal = $402,456

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	HEBREW REHABILITATION CENTER FOR AGED, INC.	1200 CENTRE ST	BOSTON	MA	02131	SUFFOLK	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	7/9/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $378,346 )
2019	2019	HEBREW REHABILITATION CENTER FOR AGED, INC.	1200 CENTRE ST	BOSTON	MA	02131	SUFFOLK	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	1	8/7/2019	NEW	$0
2019	2019	HEBREW REHABILITATION CENTER FOR AGED, INC.	1200 CENTRE ST	BOSTON	MA	02131	SUFFOLK	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	6/7/2019	NEW	$378,346
														Subtotal = $378,346

Grand Total All Awards = $1,132,769

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The Mechanistic Effects of Combined Testosterone Therapy and Exercise on Axial Bone and Muscle Post-Hip Fracture

Award Number: R01AR075346

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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