OsteoporosisNCT04815824
Exercise Mode and Acute Bone Resorption
A study testing Exercise Mode in people with Osteoporosis and Aging, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Endurance exercise is often recommended to improve cardiometabolic health and maintain bone health throughout life and to prevent osteoporotic fracture. However, there is evidence to suggest that bone does not always adapt in the way that is expected, and that endurance exercise may lead to bone loss under certain… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Aging
- What is being tested?
- Exercise Mode
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2021to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy older (60+ y) Veteran women and men will be eligible to participate
- All volunteers must be accustomed to performing 60 minutes of vigorous cycling and treadmill exercise
Who cannot join
- impaired renal function, defined as an eGRF of <60 mL/min/1.73m2;(Florkowski and Chew-Harris 2011)
- hepatobiliary disease, defined as liver function tests (AST, ALT) >1.5 times the upper limit of normal
- thyroid dysfunction, defined as an ultrasensitive thyroid stimulating hormone (TSH) <0.5 or >5.0 mU/L
- serum Ca <8.5 or >10.3 mg/dL; 5) serum 25(OH)D <20 ng/mL
- uncontrolled hypertension, defined as resting systolic blood pressure (BP) >150 mmHg or diastolic BP >90 mmHg
- history of type 1 or type 2 diabetes
Show all 13Show fewer
- cardiovascular disease; defined as subjective or objective indicators of ischemic heart disease (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the graded exercise test (GXT)
- volunteers who have a positive GXT can be re-considered after follow-up evaluation, which must include diagnostic testing (e.g., stress echocardiogram or thallium stress test) with interpretation by a cardiologist
- anemia, defined as a serum hemoglobin <12.1 g/dL for women and <14.3 g/dL for men
- fracture in the past 6 months
- current diagnosis or symptoms of COVID-19
- In the event of abnormal BP, live function, TSH, 25(OH)D, or hemoglobin values, volunteers can be reassessed, including after appropriate follow-up evaluation and treatment by a primary care provider
- Those who have experienced symptoms of COVID-19 or have been formally diagnosed will be allowed to participate once symptoms have resolved and they are approved to return to exercise by their primary care provider
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
About this study
Official title: Comparison of Exercise Mode on Disruptions in Calcium Homeostasis
Endurance exercise is often recommended to improve cardiometabolic health and maintain bone health throughout life and to prevent osteoporotic fracture. However, there is evidence to suggest that bone does not always adapt in the way that is expected, and that endurance exercise may lead to bone loss under certain conditions. Disruptions in calcium homeostasis during exercise may explain this observation, and preliminary data suggests that the mode of exercise (i.e., cycling versus treadmill) may result in different magnitudes of change in bone biomarkers. The purpose of this study is to determine if mode of exercise results in a differential bone biomarker response to an acute exercise bout in older Veterans. Blood samples will be collected before, during, and after 2 acute exercise bouts: 1) brisk treadmill walking; and 2) vigorous stationary cycling. Bouts will be matched for relative intensity and duration. This data will be used to develop future exercise interventions in older Veterans aimed at preserving both cardiometabolic and bone health.
Read the detailed description
Endurance exercise is frequently recommended as a means to reduce the risk of cardiometabolic diseases and to reduce the risk of osteoporotic fracture. However, bone does not always adapt in the way that would be expected, and there is evidence that endurance exercise may lead to bone loss under certain conditions. It is the investigators contention that disruptions in calcium homeostasis during exercise, resulting in decreases in serum ionized calcium (iCa) and increases in parathyroid hormone (PTH) and c-telopeptide of type I collagen (CTX; a marker of bone resorption) at the onset of exercise, may be responsible for the lack of improvements in bone mineral density that are anticipated. Acute studies in this area have predominantly focused on young, healthy adults, primarily men, during stationary cycling exercise. Few studies have been conducted in older adults, but those studies have found that older adults experience similar disruptions in calcium homeostasis in response to an acute bout of endurance exercise. Preliminary comparisons of the investigators studies, as well as research from other labs, also suggests that that mode of exercise conducted during these acute exercise bouts may be an important determining factor in the catabolic bone response to exercise. It appears that weight-bearing exercise (i.e., treadmill) results in smaller increases in PTH and CTX compared to weight-supported exercise (i.e., stationary cycling). This has never been tested using a within-subjects design, so it is unclear if these observed differences are due to the mode of exercise, lab-to-lab differences, or other underlying factors. To address this gap in knowledge, 30 Veterans (15 men, 15 women), aged 60+ years, will complete two 1-hour acute exercise bouts: 1) brisk treadmill walking at 70-80% of maximal heart rate; 2) vigorous stationary cycling at 70-80% maximal heart rate. Blood samples will be collected to measure iCa, PTH, CTX and procollagen type I n-terminal propeptide (P1NP) before, during, and after each exercise bout. The order of the exercise bouts will be randomized and counter-balanced. The primary aim is to determine if mode of exercise results in a differential bone biomarker response in older Veterans. This information is essential for understanding how future exercise interventions should be designed to benefit both cardiometabolic health and bone health. This is especially relevant to Veteran health due to the high burden of both cardiometabolic diseases (e.g., diabetes, heart disease) in the population, as well as evidence of increased osteoporotic fracture risk. The proposed research is significant because it is addressing a knowledge gap that has prevented the ability to design exercise and lifestyle interventions aimed at preserving multiple components of Veteran health, which could have a lasting impact on Veteran quality of life and functional independence. The proposed research is innovative because it is testing a novel hypothesis, the mode of exercise on disruptions in calcium homeostasis, in a population that could greatly benefit from the knowledge to be gained. While the proposed research is an acute study, the results generated will be used to design future clinical interventions for Veteran health. Long-term, information gained from this research will help to define the optimal exercise prescription to improve cardiometabolic without compromising bone health aging Veterans.
- Conditions
- Osteoporosis, Aging
- Being tested
- Exercise Mode
- Keywords
- exercise, bone resorption, calcium
- Medical subject headings
- Osteoporosis, Motor Activity, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ModeBehavioural
Stationary cycling or treadmill walking
| Study group | Role | What they receive |
|---|---|---|
| Stationary Cycling | Experimental | All participants will complete one, 60-minute bout of stationary cycling Receives: Behavioral: Exercise Mode |
| Treadmill Walking | Experimental | All participants will complete one, 60-minute bout of treadmill walking Receives: Behavioral: Exercise Mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-telopeptide of Type I Collagen (CTX) Change
CTX is a blood marker of bone resorption. Reference range is 0.1-0.8 ng/mL with lower concentrations suggesting less bone resorption.
Measured: Before to up to 48 hours after acute exercise bout
Secondary outcomes (1)
Procollagen of Type I N-terminal Propeptide (P1NP) Change
PINP is a blood marker of bone formation. Reference range is 19-80 ng/mL with lower concentrations suggesting less bone formation.
Measured: Before to up to 48 hours after acute exercise bout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start8 Oct 2021
- Primary completion30 Jun 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover design comparing mode of endurance exercise (cycling versus treadmill).
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- Sarah J Wherry, PhD, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815824
- Sponsor's protocol ID
- F3593-P
- Other IDs
- 1I21RX003593
- Status last verified
- Jul 2025
- First submitted
- 22 Mar 2021
- Last updated
- 20 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Exercise Mode on Disruptions in Calcium Homeostasis
- ClinicalTrials.gov ID
- NCT04815824
- Acronym / sponsor ID
- F3593-P
- Conditions
- Osteoporosis, Aging
- Keywords
- exercise, bone resorption, calcium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Colorado, Denver
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Posted 20 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endurance exercise is often recommended to improve cardiometabolic health and maintain bone health throughout life and to prevent osteoporotic fracture. However, there is evidence to suggest that bone does not always adapt in the way that is expected, and that endurance exercise may lead to bone loss under certain conditions. Disruptions in calcium homeostasis during exercise may explain this observation, and preliminary data suggests that the mode of exercise (i.e., cycling versus treadmill) may result in different magnitudes of change in bone biomarkers. The purpose of this study is to determine if mode of exercise results in a differential bone biomarker response to an acute exercise bout in older Veterans. Blood samples will be collected before, during, and after 2 acute exercise bouts: 1) brisk treadmill walking; and 2) vigorous stationary cycling. Bouts will be matched for relative intensity and duration. This data will be used to develop future exercise interventions in older Veterans aimed at preserving both cardiometabolic and bone health.
Detailed description
Endurance exercise is frequently recommended as a means to reduce the risk of cardiometabolic diseases and to reduce the risk of osteoporotic fracture. However, bone does not always adapt in the way that would be expected, and there is evidence that endurance exercise may lead to bone loss under certain conditions. It is the investigators contention that disruptions in calcium homeostasis during exercise, resulting in decreases in serum ionized calcium (iCa) and increases in parathyroid hormone (PTH) and c-telopeptide of type I collagen (CTX; a marker of bone resorption) at the onset of exercise, may be responsible for the lack of improvements in bone mineral density that are anticipated. Acute studies in this area have predominantly focused on young, healthy adults, primarily men, during stationary cycling exercise. Few studies have been conducted in older adults, but those studies have found that older adults experience similar disruptions in calcium homeostasis in response to an acute bout of endurance exercise. Preliminary comparisons of the investigators studies, as well as research from other labs, also suggests that that mode of exercise conducted during these acute exercise bouts may be an important determining factor in the catabolic bone response to exercise. It appears that weight-bearing exercise (i.e., treadmill) results in smaller increases in PTH and CTX compared to weight-supported exercise (i.e., stationary cycling). This has never been tested using a within-subjects design, so it is unclear if these observed differences are due to the mode of exercise, lab-to-lab differences, or other underlying factors. To address this gap in knowledge, 30 Veterans (15 men, 15 women), aged 60+ years, will complete two 1-hour acute exercise bouts: 1) brisk treadmill walking at 70-80% of maximal heart rate; 2) vigorous stationary cycling at 70-80% maximal heart rate. Blood samples will be collected to measure iCa, PTH, CTX and procollagen type I n-terminal propeptide (P1NP) before, during, and after each exercise bout. The order of the exercise bouts will be randomized and counter-balanced. The primary aim is to determine if mode of exercise results in a differential bone biomarker response in older Veterans. This information is essential for understanding how future exercise interventions should be designed to benefit both cardiometabolic health and bone health. This is especially relevant to Veteran health due to the high burden of both cardiometabolic diseases (e.g., diabetes, heart disease) in the population, as well as evidence of increased osteoporotic fracture risk. The proposed research is significant because it is addressing a knowledge gap that has prevented the ability to design exercise and lifestyle interventions aimed at preserving multiple components of Veteran health, which could have a lasting impact on Veteran quality of life and functional independence. The proposed research is innovative because it is testing a novel hypothesis, the mode of exercise on disruptions in calcium homeostasis, in a population that could greatly benefit from the knowledge to be gained. While the proposed research is an acute study, the results generated will be used to design future clinical interventions for Veteran health. Long-term, information gained from this research will help to define the optimal exercise prescription to improve cardiometabolic without compromising bone health aging Veterans.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover design comparing mode of endurance exercise (cycling versus treadmill).
| Arm | Type | Receives |
|---|---|---|
| Stationary Cycling | Experimental | Behavioral: Exercise ModeAll participants will complete one, 60-minute bout of stationary cycling |
| Treadmill Walking | Experimental | Behavioral: Exercise ModeAll participants will complete one, 60-minute bout of treadmill walking |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy older (60+ y) Veteran women and men will be eligible to participate
- All volunteers must be accustomed to performing 60 minutes of vigorous cycling and treadmill exercise
Key exclusion criteria (13 listed)
- impaired renal function, defined as an eGRF of <60 mL/min/1.73m2;(Florkowski and Chew-Harris 2011)
- hepatobiliary disease, defined as liver function tests (AST, ALT) >1.5 times the upper limit of normal
- thyroid dysfunction, defined as an ultrasensitive thyroid stimulating hormone (TSH) <0.5 or >5.0 mU/L
- serum Ca <8.5 or >10.3 mg/dL; 5) serum 25(OH)D <20 ng/mL
- uncontrolled hypertension, defined as resting systolic blood pressure (BP) >150 mmHg or diastolic BP >90 mmHg
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 |
|---|---|---|
| Exercise ModeStationary cycling or treadmill walking | Behavioural | Stationary Cycling, Treadmill Walking |
Primary outcome
C-telopeptide of Type I Collagen (CTX) Change
Time frame: Before to up to 48 hours after acute exercise bout
CTX is a blood marker of bone resorption. Reference range is 0.1-0.8 ng/mL with lower concentrations suggesting less bone resorption.
1 secondary outcome
Procollagen of Type I N-terminal Propeptide (P1NP) Change
Time frame: Before to up to 48 hours after acute exercise bout
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sarah J Wherry, PhD principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Mode in people with Osteoporosis and Aging, run by VA Office of Research and Development at 1 site 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 2 inclusion and 13 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 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 20 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
C-telopeptide of Type I Collagen (CTX) Change (time frame: Before to up to 48 hours after acute exercise bout). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2025.