OsteoporosisNCT00572871
Hormonal and Bone Turnover Marker Response to an Acute Bout of Resistance or Plyometric Exercise
An observational study of Osteoporosis and Osteopenia, run by University of Missouri-Columbia.
Trial summary
We are interested in determining if there exist a short-term response in the serum markers and hormones that participate in the regulation of bone tissue formation and breakdown to a single, high-intensity exercise session of weight lifting (resistance exercise) or jumping (plyometrics). Read more about this study
- Who is it for?
- Ages 25 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteopenia
- What is being tested?
- plyometric exercise, resistance exercise and No exercise
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to Dec 2009
- Phase
- Observational
- 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 25 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male participants apparently healthy and non-sedentary free of disease that affects bone and not have used or currently use any medication that affects bone.
Who may be able to join
- Male
- No symptoms of disease
- Non-sedentary
- Age 25-65
Who cannot join
- Medications or supplements that affect bone metabolism or prevent exercise
- Previous or current medical condition affecting bone health, including osteoporosis.
- Cardiovascular disease
- Metallic implants affecting accuracy of bone density scan
- Current smoker
- Current participation in high-intensity jumping or resistance exercise in the last 3 months.
About this study
We are interested in determining if there exist a short-term response in the serum markers and hormones that participate in the regulation of bone tissue formation and breakdown to a single, high-intensity exercise session of weight lifting (resistance exercise) or jumping (plyometrics). We are also interested in determining if the bone marker response to exercise is altered by changing the negative energy state caused by the exercise treatment, when subjects are given a moderate calorie meal.
Read the detailed description
Bone tissue responds to impact and strain forces, like high-intensity exercise, by upregulating the bone remolding process, resulting in the deposition of calcium phosphate minerals into the collagen matrix of bone. Bone remodeling is a continually active process that involves both activation cells regulating bone formation (osteoblasts) and resorption (osteoclasts). Alterations in the balance between formation and resorption are critical for changes in bone density and mineral content to occur, which is regulated by several hormones including vitamin D and growth hormone, the sex hormones estrogen and testosterone, and parathyroid hormone. Importantly, it remains unclear how single bouts of physical activity contribute to the overall changes in remodeling and whether those acute alterations can be detected in the hours after exercise. Additionally, research studies examining the effects of exercise on bone remodeling often draw blood samples after 24 hours of physical inactivity, potentially diminishing the magnitude of the exercise response. Therefore, we plan to evaluate the acute effects of plyometrics and resistance exercise on changes in serum hormones and markers of bone turnover in non-sedentary, healthy males, with or without a moderate calorie supplement.
- Conditions
- Osteoporosis, Osteopenia
- Being tested
- plyometric exercise, resistance exercise, No exercise
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plyometric exerciseOther
single bout of plyometric exercise
resistance exerciseOther
single bout of resistance exercise
No exerciseOther
Will not do any exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise after fasting | Will complete 2 resistance exercise sessions and 2 plyometric exercise sessions after a 10-hour fast Receives: Other: resistance exercise | |
| No exercise | Will complete a ten-hour fast but do no exercise Receives: Other: No exercise | |
| Exercise after snack | Will complete 2 resistance exercise sessions and 2 plyometric exercise sessions 2 hours following a 500 calorie nutritional supplement Receives: Other: plyometric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum bone turnover markers
Measured: 24 hours
Secondary outcomes (1)
serum hormones regulating bone turnover
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela S Hinton, Ph.D., Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572871
- Sponsor's protocol ID
- 1097239
- Other IDs
- 65438
- Status last verified
- Sep 2016
- First submitted
- 12 Dec 2007
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormonal and Bone Turnover Marker Response to an Acute Bout of Resistance or Plyometric Exercise
- ClinicalTrials.gov ID
- NCT00572871
- Acronym / sponsor ID
- 1097239
- Conditions
- Osteoporosis, Osteopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 13 Dec 2007 (estimated)
- 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.
We are interested in determining if there exist a short-term response in the serum markers and hormones that participate in the regulation of bone tissue formation and breakdown to a single, high-intensity exercise session of weight lifting (resistance exercise) or jumping (plyometrics). We are also interested in determining if the bone marker response to exercise is altered by changing the negative energy state caused by the exercise treatment, when subjects are given a moderate calorie meal.
Detailed description
Bone tissue responds to impact and strain forces, like high-intensity exercise, by upregulating the bone remolding process, resulting in the deposition of calcium phosphate minerals into the collagen matrix of bone. Bone remodeling is a continually active process that involves both activation cells regulating bone formation (osteoblasts) and resorption (osteoclasts). Alterations in the balance between formation and resorption are critical for changes in bone density and mineral content to occur, which is regulated by several hormones including vitamin D and growth hormone, the sex hormones estrogen and testosterone, and parathyroid hormone. Importantly, it remains unclear how single bouts of physical activity contribute to the overall changes in remodeling and whether those acute alterations can be detected in the hours after exercise. Additionally, research studies examining the effects of exercise on bone remodeling often draw blood samples after 24 hours of physical inactivity, potentially diminishing the magnitude of the exercise response. Therefore, we plan to evaluate the acute effects of plyometrics and resistance exercise on changes in serum hormones and markers of bone turnover in non-sedentary, healthy males, with or without a moderate calorie supplement.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise after fasting | – | Other: resistance exerciseWill complete 2 resistance exercise sessions and 2 plyometric exercise sessions after a 10-hour fast |
| No exercise | – | Other: No exerciseWill complete a ten-hour fast but do no exercise |
| Exercise after snack | – | Other: plyometric exerciseWill complete 2 resistance exercise sessions and 2 plyometric exercise sessions 2 hours following a 500 calorie nutritional supplement |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male participants apparently healthy and non-sedentary free of disease that affects bone and not have used or currently use any medication that affects bone.
Key inclusion criteria (4 listed)
- Male
- No symptoms of disease
- Non-sedentary
- Age 25-65
Key exclusion criteria (6 listed)
- Medications or supplements that affect bone metabolism or prevent exercise
- Previous or current medical condition affecting bone health, including osteoporosis.
- Cardiovascular disease
- Metallic implants affecting accuracy of bone density scan
- Current smoker
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 |
|---|---|---|
| plyometric exercisesingle bout of plyometric exercise | Other | Exercise after snack |
| resistance exercisesingle bout of resistance exercise | Other | Exercise after fasting |
| No exerciseWill not do any exercise | Other | No exercise |
Primary outcome
serum bone turnover markers
Time frame: 24 hours
1 secondary outcome
serum hormones regulating bone turnover
Time frame: 24 hours
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 4 Oct 2016.
- 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.
Pamela S Hinton, Ph.D. principal investigator
University of Missouri-Columbia
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Osteopenia, run by University of Missouri-Columbia.
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 4 inclusion and 6 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 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
serum bone turnover markers (time frame: 24 hours). 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 4 Oct 2016.