ExerciseBoBCATNCT06972862
Bone and Body Composition Adaptations to Physical Training
A study testing Osteogenic Index Optimized Exercise Training Program in people with Exercise and Healthy, run by University of Pittsburgh at 2 sites in United States.
Trial summary
The goal of this clinical trial is to evaluate how different exercise programs alter bone density, structure, and strength in adults. It will also collect data on hormones, factors released from skeletal muscle, and body composition. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- What is being tested?
- Osteogenic Index Optimized Exercise Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Aug 2022to 27 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-40 years
- Body mass index (BMI) 18-28 kg/m2
- Weight stable (±10 lbs) in past 2 months
- Takes part in moderate physical activity for at least 150 minutes/week
- Currently free of upper or lower body /extremity injury or impairment
- Comfortable with multiple blood draws
- Able to commit to the 6-month study duration
- Agrees to adhere to study requirements.
Who cannot join
- Current smoker
- Current clinical diagnosis of an eating disorder
- Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs). NSAID use is defined as chronic if these medications are taken more than three times a week for more than 12 consecutive weeks.
- Use of medication incompatible with measurement of reproductive, metabolic, or bone-related hormones (including thyroid medications, glucocorticoids) or which includes anti-coagulants and may interfere with any of the study outcomes
- Current oligo/amenorrhea in women, not explained by contraceptive use
- Any metabolic or endocrine disease that affects bone; Individuals taking hormonal therapy for transgender care
Show all 18Show fewer
- Currently training for a competitive sporting event or planning to start
- Weight has fluctuated by 10 pounds or more in the past 2 months based on subject self-report
- Has been diagnosed with a medical condition, physical or psychological, that currently prevents exercise participation
- Has suffered a musculoskeletal injury removing them from physical activity for more than a month, within the past two years
- Currently pregnant or becomes pregnant during the study (as assessed by urine pregnancy tests at 0, 3 \& 6 months)
- Current asthma diagnosis, defined as experienced symptoms or been prescribed any form of treatment within the last 4 years, or those who have required more than one course of oral steroids or more than one nebulization since the age of 5 (JSP 950), will require a note/permission from treating physician to participate in study. Those who have had a single admission to intensive care or high dependency, or multiple admissions to hospital will be excluded from participating (JSP 950)
- History of heart condition OR high blood pressure
- Feeling of pain in the chest during rest, activities of daily living, or physical activity
- Have lost balance or consciousness due to dizziness in the last 12 months (with the exception of dizziness due to hyperventilation)
- Treating physician requires subject participates in medically supervised physical activity only
- History of drug addiction or habitual recreational drug use (2 or more times per month in each of the previous six months)
- Low bone mineral density indicated as a Z-score <-1.0 measured by dual-energy x-ray absorptiometry (DXA)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas, Jayhawk Performance Laboratory
Lawrence, Kansas, 66045
Neuromuscular Research Laboratory
Pittsburgh, Pennsylvania, 15203
About this study
Official title: Optimizing Muscle and Bone Mechanoadaptation to Physical Training: Mechanistic Control Paths Via Muscle and Bone Crosstalk to Altered Mechanical Loading
The goal of this clinical trial is to evaluate how different exercise programs alter bone density, structure, and strength in adults. It will also collect data on hormones, factors released from skeletal muscle, and body composition.
The main questions it aims to answer are:
Read more
- Do exercise programs that are frequent with high-impact loading will cause greater improvements in bone health?
- What changes in hormones, factors released from skeletal muscle, and body composition contribute to bone adaptations?
Researchers will compare different exercise groups to see if the type of exercise influences bone adaptation compared to a recreationally active control group.
Participants are asked to:
- complete questionnaires, 5 blood draws across the study (3 at rest, 2 after strenuous exercise), dual energy x-ray absorptiometry (DXA) scans (to assess bone mineral density and body composition), high resolution tibial scans to assess bone structure and geometry, and physical performance testing.
- attend up to 7 testing visits.
- (for those randomized to the exercise training intervention) participate in exercise training sessions for 6 months.
Read the detailed description
The overall objective of this study is to determine the bone density, structure and strength adaptations that result from various exercise programs which differ based on the frequency and intensity of bone loading. Bone adaptation is measured with both dual-energy x-ray absorptiometry (DXA), the standard-of-care equipment used to evaluate bone mineral density (BMD), and high-resolution peripheral quantitative computed tomography (HRpQCT), a state-of-the-science imaging technology providing the resolution necessary to detect small but clinically relevant changes.
Additionally, the research team seeks to determine the physiological responses and adaptations to training that contribute to improved bone health by evaluating changes in hormones, factors released from active skeletal muscle, and body composition. Our hypothesis is that exercise programs emphasizing frequent, high impact loading will cause greater improvements in bone health. Additionally, we believe that exercise training can induce specific changes in hormones, skeletal muscle released signaling factors and body composition that contribute to these bone adaptations.
Participants who enrolled in this study were randomized to either an exercise training group or a control group who were instructed to maintain their current level of exercise and track this to report to the study team. Study completers were those who complied with the parameters of the group they were assigned and reported to all 7 testing visits.
- Being tested
- Osteogenic Index Optimized Exercise Training Program
- Keywords
- bone health, body composition, skeletal muscle, hormones, exercise intervention, recreational athletes, bone marrow adipose tissue, bone formation, bone resportion, bone geometry, bone microarchitecture, bone mineral density
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteogenic Index Optimized Exercise Training ProgramOther
Also called Exercise Intervention
The OI- Optimized Training is 6 months of planned, non-linear periodized training on a leg press machine called the PPM (Athletic Republic, Salt Lake City, UT) with a maintenance program during the semester breaks, as necessary.
| Study group | Role | What they receive |
|---|---|---|
| Laboratory Based Osteogenic Index (OI) Optimized Training Group | Experimental | The OI- Optimized Training Group will involve 6 months of planned, non-linear periodized training on a leg press machine called the PPM (Athletic Republic, Salt Lake City, UT) with a maintenance program during the semester breaks, as necessary. Receives: Other: Osteogenic Index Optimized Exercise Training Program |
| Laboratory Based Control Group | No intervention | The control group will maintain their habitual exercise, diet, and sleep patterns, all of which will be monitored throughout the study. |
| Reserve Officer Training Corps (ROTC): Observational Group | No intervention | The ROTC group is made up of Reserve Officer Training Corps participants who are attending a university while concurrently undergoing militaristic training. This group will maintain their physical training as part of their program, diet, and sleep patterns which are monitored throughout the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone microarchitecture: Change in bone microarchitecture as measured via High Resolution- peripheral Quantitative Computed Tomography, change from baseline, mean
Measured: Through study completion, an average of 6 months.
Bone strength: Change in bone strength as measured via High Resolution- peripheral Quantitative Computed Tomography, change from baseline, mean
Measured: Through study completion, an average of 6 months
Secondary outcomes (8)
Biochemical: Change in concentration of Bone alkaline phosphatase (BAP), change from baseline, mean
BAP is a bone formation marker.
Measured: Through study completion, an average of 6 months
Biochemical: Change in concentration of Procollagen type I N-terminal Propeptide (P1NP), change from baseline, mean
P1NP is a bone formation marker.
Measured: Through study completion, an average of 6 months
Biochemical: Change in concentration of Tartrate-resistant acid phosphatase 5b (TRAP5b), change from baseline, mean
TRAP5b is a bone resorption marker.
Measured: Through study completion, an average of 6 months
Biochemical: Change in concentration of Beta Cross-linking Telopeptide of type I (B-CTx) collagen, change form baseline, mean
B-CTx is a bone resorption marker.
Measured: Through study completion, an average of 6 months
Bone characteristics: Change in amount of Bone Marrow Adipose Tissue, change from baseline, mean
Measured: Through study completion, an average of 6 months
Biochemical: Change in extracellular vesicle size, change from baseline and through study completion, mean
This is a descriptive analysis in which the mean size of the extracellular vesicles will be assessed via nanoparticle tracking analysis between groups and throughout the study.
Measured: Through study completion, an average of 6 months
Biochemical: Change in extracellular vesicle constituent cargo, change from baseline and through study, mean
This is a descriptive analysis in which the mean contents of the extracellular vesicles will be assessed via proteomics between groups and throughout the study.
Measured: Through study completion, an average of 6 months
Biocehmical: Rate of change in micro- RNA expression, from baseline through study completion, Log2 Fold Change between groups
A descriptive analysis will be performed in which the micro-RNA expression in each group will be compared via the Log2 Fold Change (a type of rate of change) mathematical formula (Log2 Fold Change (LogFC): log2(Expression Level (Group 1) / Expression Level (Group 2))).
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start29 Aug 2022
- Primary completion27 Apr 2025
- Study completion27 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Principal investigator, Bradley Nindl, University of Pittsburgh
- Investigators
- Kristen J Koltun, PhD, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972862
- Sponsor's protocol ID
- STUDY21020044
- Other IDs
- W81XWH-21-1-0542
- Acronym
- BoBCAT
- Status last verified
- Aug 2026
- First submitted
- 28 Apr 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported, after identification (text, tables, figures, and appendices).
Publications
Allaway HC, Williams NI, Mallinson RJ, Koehler K, De Souza MJ. Reductions in urinary collection frequency for assessment of reproductive hormones provide physiologically representative exposure and mean concentrations when compared with daily collection. Am J Hum Biol. 2015 May-Jun;27(3):358-71. doi: 10.1002/ajhb.22649. Epub 2014 Oct 29.
PubMed 25353669Nindl BC, Urso ML, Pierce JR, Scofield DE, Barnes BR, Kraemer WJ, Anderson JM, Maresh CM, Beasley KN, Zambraski EJ. IGF-I measurement across blood, interstitial fluid, and muscle biocompartments following explosive, high-power exercise. Am J Physiol Regul Integr Comp Physiol. 2012 Nov 15;303(10):R1080-9. doi: 10.1152/ajpregu.00275.2012. Epub 2012 Aug 29.
PubMed 22933025Lester ME, Urso ML, Evans RK, Pierce JR, Spiering BA, Maresh CM, Hatfield DL, Kraemer WJ, Nindl BC. Influence of exercise mode and osteogenic index on bone biomarker responses during short-term physical training. Bone. 2009 Oct;45(4):768-76. doi: 10.1016/j.bone.2009.06.001. Epub 2009 Jun 9.
PubMed 19520194Carson JA, Manolagas SC. Effects of sex steroids on bones and muscles: Similarities, parallels, and putative interactions in health and disease. Bone. 2015 Nov;80:67-78. doi: 10.1016/j.bone.2015.04.015.
PubMed 26453497Wentz L, Liu PY, Haymes E, Ilich JZ. Females have a greater incidence of stress fractures than males in both military and athletic populations: a systemic review. Mil Med. 2011 Apr;176(4):420-30. doi: 10.7205/milmed-d-10-00322.
PubMed 21539165Rantalainen T, Nikander R, Heinonen A, Cervinka T, Sievanen H, Daly RM. Differential effects of exercise on tibial shaft marrow density in young female athletes. J Clin Endocrinol Metab. 2013 May;98(5):2037-44. doi: 10.1210/jc.2012-3748. Epub 2013 Apr 24.
PubMed 23616150Singhal V, Torre Flores LP, Stanford FC, Toth AT, Carmine B, Misra M, Bredella MA. Differential associations between appendicular and axial marrow adipose tissue with bone microarchitecture in adolescents and young adults with obesity. Bone. 2018 Nov;116:203-206. doi: 10.1016/j.bone.2018.08.009. Epub 2018 Aug 11.
PubMed 30107255Gorgey AS, Poarch HJ, Adler RA, Khalil RE, Gater DR. Femoral bone marrow adiposity and cortical bone cross-sectional areas in men with motor complete spinal cord injury. PM R. 2013 Nov;5(11):939-48. doi: 10.1016/j.pmrj.2013.05.006. Epub 2013 May 15.
PubMed 23684921Sanford JA, Nogiec CD, Lindholm ME, Adkins JN, Amar D, Dasari S, Drugan JK, Fernandez FM, Radom-Aizik S, Schenk S, Snyder MP, Tracy RP, Vanderboom P, Trappe S, Walsh MJ; Molecular Transducers of Physical Activity Consortium. Molecular Transducers of Physical Activity Consortium (MoTrPAC): Mapping the Dynamic Responses to Exercise. Cell. 2020 Jun 25;181(7):1464-1474. doi: 10.1016/j.cell.2020.06.004.
PubMed 32589957Whitham M, Parker BL, Friedrichsen M, Hingst JR, Hjorth M, Hughes WE, Egan CL, Cron L, Watt KI, Kuchel RP, Jayasooriah N, Estevez E, Petzold T, Suter CM, Gregorevic P, Kiens B, Richter EA, James DE, Wojtaszewski JFP, Febbraio MA. Extracellular Vesicles Provide a Means for Tissue Crosstalk during Exercise. Cell Metab. 2018 Jan 9;27(1):237-251.e4. doi: 10.1016/j.cmet.2017.12.001.
PubMed 29320704Norheim F, Langleite TM, Hjorth M, Holen T, Kielland A, Stadheim HK, Gulseth HL, Birkeland KI, Jensen J, Drevon CA. The effects of acute and chronic exercise on PGC-1alpha, irisin and browning of subcutaneous adipose tissue in humans. FEBS J. 2014 Feb;281(3):739-49. doi: 10.1111/febs.12619. Epub 2013 Dec 10.
PubMed 24237962Robling AG, Niziolek PJ, Baldridge LA, Condon KW, Allen MR, Alam I, Mantila SM, Gluhak-Heinrich J, Bellido TM, Harris SE, Turner CH. Mechanical stimulation of bone in vivo reduces osteocyte expression of Sost/sclerostin. J Biol Chem. 2008 Feb 29;283(9):5866-75. doi: 10.1074/jbc.M705092200. Epub 2007 Dec 17.
PubMed 18089564Bonewald LF, Johnson ML. Osteocytes, mechanosensing and Wnt signaling. Bone. 2008 Apr;42(4):606-15. doi: 10.1016/j.bone.2007.12.224. Epub 2008 Jan 12.
PubMed 18280232Evans RK, Negus CH, Centi AJ, Spiering BA, Kraemer WJ, Nindl BC. Peripheral QCT sector analysis reveals early exercise-induced increases in tibial bone mineral density. J Musculoskelet Neuronal Interact. 2012 Sep;12(3):155-64.
PubMed 22947547Hughes JM, Gaffney-Stomberg E, Guerriere KI, Taylor KM, Popp KL, Xu C, Unnikrishnan G, Staab JS, Matheny RW Jr, McClung JP, Reifman J, Bouxsein ML. Changes in tibial bone microarchitecture in female recruits in response to 8 weeks of U.S. Army Basic Combat Training. Bone. 2018 Aug;113:9-16. doi: 10.1016/j.bone.2018.04.021. Epub 2018 Apr 27.
PubMed 29709620
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Muscle and Bone Mechanoadaptation to Physical Training: Mechanistic Control Paths Via Muscle and Bone Crosstalk to Altered Mechanical Loading
- ClinicalTrials.gov ID
- NCT06972862
- Acronym / sponsor ID
- BoBCAT / STUDY21020044
- Keywords
- bone health, body composition, skeletal muscle, hormones, exercise intervention, recreational athletes, bone marrow adipose tissue, bone formation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 27 Apr 2025 (actual)
- Study completion
- 27 Apr 2025 (actual)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate how different exercise programs alter bone density, structure, and strength in adults. It will also collect data on hormones, factors released from skeletal muscle, and body composition.
The main questions it aims to answer are:
- Do exercise programs that are frequent with high-impact loading will cause greater improvements in bone health?
- What changes in hormones, factors released from skeletal muscle, and body composition contribute to bone adaptations?
Researchers will compare different exercise groups to see if the type of exercise influences bone adaptation compared to a recreationally active control group.
Participants are asked to:
- complete questionnaires, 5 blood draws across the study (3 at rest, 2 after strenuous exercise), dual energy x-ray absorptiometry (DXA) scans (to assess bone mineral density and body composition), high resolution tibial scans to assess bone structure and geometry, and physical performance testing.
- attend up to 7 testing visits.
- (for those randomized to the exercise training intervention) participate in exercise training sessions for 6 months.
Detailed description
The overall objective of this study is to determine the bone density, structure and strength adaptations that result from various exercise programs which differ based on the frequency and intensity of bone loading. Bone adaptation is measured with both dual-energy x-ray absorptiometry (DXA), the standard-of-care equipment used to evaluate bone mineral density (BMD), and high-resolution peripheral quantitative computed tomography (HRpQCT), a state-of-the-science imaging technology providing the resolution necessary to detect small but clinically relevant changes.
Additionally, the research team seeks to determine the physiological responses and adaptations to training that contribute to improved bone health by evaluating changes in hormones, factors released from active skeletal muscle, and body composition. Our hypothesis is that exercise programs emphasizing frequent, high impact loading will cause greater improvements in bone health. Additionally, we believe that exercise training can induce specific changes in hormones, skeletal muscle released signaling factors and body composition that contribute to these bone adaptations.
Participants who enrolled in this study were randomized to either an exercise training group or a control group who were instructed to maintain their current level of exercise and track this to report to the study team. Study completers were those who complied with the parameters of the group they were assigned and reported to all 7 testing visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laboratory Based Osteogenic Index (OI) Optimized Training Group | Experimental | Other: Osteogenic Index Optimized Exercise Training ProgramThe OI- Optimized Training Group will involve 6 months of planned, non-linear periodized training on a leg press machine called the PPM (Athletic Republic, Salt Lake City, UT) with a maintenance program during the semester breaks, as necessary. |
| Laboratory Based Control Group | No intervention | –The control group will maintain their habitual exercise, diet, and sleep patterns, all of which will be monitored throughout the study. |
| Reserve Officer Training Corps (ROTC): Observational Group | No intervention | –The ROTC group is made up of Reserve Officer Training Corps participants who are attending a university while concurrently undergoing militaristic training. This group will maintain their physical training as part of their program, diet, and sleep patterns which are monitored throughout the study. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18-40 years
- Body mass index (BMI) 18-28 kg/m2
- Weight stable (±10 lbs) in past 2 months
- Takes part in moderate physical activity for at least 150 minutes/week
- Currently free of upper or lower body /extremity injury or impairment
Key exclusion criteria (18 listed)
- Current smoker
- Current clinical diagnosis of an eating disorder
- Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs). NSAID use is defined as chronic if these medications are taken more than three times a week for more than 12 consecutive weeks.
- Use of medication incompatible with measurement of reproductive, metabolic, or bone-related hormones (including thyroid medications, glucocorticoids) or which includes anti-coagulants and may interfere with any of the study outcomes
- Current oligo/amenorrhea in women, not explained by contraceptive use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteogenic Index Optimized Exercise Training ProgramAlso: Exercise InterventionThe OI- Optimized Training is 6 months of planned, non-linear periodized training on a leg press machine called the PPM (Athletic Republic, Salt Lake City, UT) with a maintenance program during the semester breaks, as necessary. | Other | Laboratory Based Osteogenic Index (OI) Optimized Training Group |
Primary outcome
Bone microarchitecture: Change in bone microarchitecture as measured via High Resolution- peripheral Quantitative Computed Tomography, change from baseline, mean
Time frame: Through study completion, an average of 6 months.
Bone strength: Change in bone strength as measured via High Resolution- peripheral Quantitative Computed Tomography, change from baseline, mean
Time frame: Through study completion, an average of 6 months
8 secondary outcomes
Biochemical: Change in concentration of Bone alkaline phosphatase (BAP), change from baseline, mean
Time frame: Through study completion, an average of 6 months
Biochemical: Change in concentration of Procollagen type I N-terminal Propeptide (P1NP), change from baseline, mean
Time frame: Through study completion, an average of 6 months
Biochemical: Change in concentration of Tartrate-resistant acid phosphatase 5b (TRAP5b), change from baseline, mean
Time frame: Through study completion, an average of 6 months
Biochemical: Change in concentration of Beta Cross-linking Telopeptide of type I (B-CTx) collagen, change form baseline, mean
Time frame: Through study completion, an average of 6 months
Bone characteristics: Change in amount of Bone Marrow Adipose Tissue, change from baseline, mean
Time frame: Through study completion, an average of 6 months
Biochemical: Change in extracellular vesicle size, change from baseline and through study completion, mean
Time frame: Through study completion, an average of 6 months
Biochemical: Change in extracellular vesicle constituent cargo, change from baseline and through study, mean
Time frame: Through study completion, an average of 6 months
Biocehmical: Rate of change in micro- RNA expression, from baseline through study completion, Log2 Fold Change between groups
Time frame: Through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 25353669Allaway HC, Williams NI, Mallinson RJ, Koehler K, De Souza MJ. Reductions in urinary collection frequency for assessment of reproductive hormones provide physiologically representative exposure and mean concentrations when compared with daily collection. Am J Hum Biol. 2015 May-Jun;27(3):358-71. doi: 10.1002/ajhb.22649. Epub 2014 Oct 29.
- Background: PubMed 22933025Nindl BC, Urso ML, Pierce JR, Scofield DE, Barnes BR, Kraemer WJ, Anderson JM, Maresh CM, Beasley KN, Zambraski EJ. IGF-I measurement across blood, interstitial fluid, and muscle biocompartments following explosive, high-power exercise. Am J Physiol Regul Integr Comp Physiol. 2012 Nov 15;303(10):R1080-9. doi: 10.1152/ajpregu.00275.2012. Epub 2012 Aug 29.
- Background: PubMed 19520194Lester ME, Urso ML, Evans RK, Pierce JR, Spiering BA, Maresh CM, Hatfield DL, Kraemer WJ, Nindl BC. Influence of exercise mode and osteogenic index on bone biomarker responses during short-term physical training. Bone. 2009 Oct;45(4):768-76. doi: 10.1016/j.bone.2009.06.001. Epub 2009 Jun 9.
- Background: PubMed 26453497Carson JA, Manolagas SC. Effects of sex steroids on bones and muscles: Similarities, parallels, and putative interactions in health and disease. Bone. 2015 Nov;80:67-78. doi: 10.1016/j.bone.2015.04.015.
- Background: PubMed 21539165Wentz L, Liu PY, Haymes E, Ilich JZ. Females have a greater incidence of stress fractures than males in both military and athletic populations: a systemic review. Mil Med. 2011 Apr;176(4):420-30. doi: 10.7205/milmed-d-10-00322.
- Background: PubMed 23616150Rantalainen T, Nikander R, Heinonen A, Cervinka T, Sievanen H, Daly RM. Differential effects of exercise on tibial shaft marrow density in young female athletes. J Clin Endocrinol Metab. 2013 May;98(5):2037-44. doi: 10.1210/jc.2012-3748. Epub 2013 Apr 24.
- Background: PubMed 30107255Singhal V, Torre Flores LP, Stanford FC, Toth AT, Carmine B, Misra M, Bredella MA. Differential associations between appendicular and axial marrow adipose tissue with bone microarchitecture in adolescents and young adults with obesity. Bone. 2018 Nov;116:203-206. doi: 10.1016/j.bone.2018.08.009. Epub 2018 Aug 11.
- Background: PubMed 23684921Gorgey AS, Poarch HJ, Adler RA, Khalil RE, Gater DR. Femoral bone marrow adiposity and cortical bone cross-sectional areas in men with motor complete spinal cord injury. PM R. 2013 Nov;5(11):939-48. doi: 10.1016/j.pmrj.2013.05.006. Epub 2013 May 15.
- Background: PubMed 32589957Sanford JA, Nogiec CD, Lindholm ME, Adkins JN, Amar D, Dasari S, Drugan JK, Fernandez FM, Radom-Aizik S, Schenk S, Snyder MP, Tracy RP, Vanderboom P, Trappe S, Walsh MJ; Molecular Transducers of Physical Activity Consortium. Molecular Transducers of Physical Activity Consortium (MoTrPAC): Mapping the Dynamic Responses to Exercise. Cell. 2020 Jun 25;181(7):1464-1474. doi: 10.1016/j.cell.2020.06.004.
- Background: PubMed 29320704Whitham M, Parker BL, Friedrichsen M, Hingst JR, Hjorth M, Hughes WE, Egan CL, Cron L, Watt KI, Kuchel RP, Jayasooriah N, Estevez E, Petzold T, Suter CM, Gregorevic P, Kiens B, Richter EA, James DE, Wojtaszewski JFP, Febbraio MA. Extracellular Vesicles Provide a Means for Tissue Crosstalk during Exercise. Cell Metab. 2018 Jan 9;27(1):237-251.e4. doi: 10.1016/j.cmet.2017.12.001.
- Background: PubMed 24237962Norheim F, Langleite TM, Hjorth M, Holen T, Kielland A, Stadheim HK, Gulseth HL, Birkeland KI, Jensen J, Drevon CA. The effects of acute and chronic exercise on PGC-1alpha, irisin and browning of subcutaneous adipose tissue in humans. FEBS J. 2014 Feb;281(3):739-49. doi: 10.1111/febs.12619. Epub 2013 Dec 10.
- Background: PubMed 18089564Robling AG, Niziolek PJ, Baldridge LA, Condon KW, Allen MR, Alam I, Mantila SM, Gluhak-Heinrich J, Bellido TM, Harris SE, Turner CH. Mechanical stimulation of bone in vivo reduces osteocyte expression of Sost/sclerostin. J Biol Chem. 2008 Feb 29;283(9):5866-75. doi: 10.1074/jbc.M705092200. Epub 2007 Dec 17.
- Neuromuscular Research Laboratory WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported, after identification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen J Koltun, PhD study director
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteogenic Index Optimized Exercise Training Program in people with Exercise and Healthy, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone microarchitecture: Change in bone microarchitecture as measured via High Resolution- peripheral Quantitative Computed Tomography, change from baseline, mean (time frame: Through study completion, an average of 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06972862, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.