OsteoporosisNCT02468817
PTH And Calcium Responses to Exercise (PACE) in Older Adults
A study testing Treadmill Exercise and Magnitude of Ca loss during Exercise at 26 degrees Celcius in people with Osteoporosis, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Exercise that causes a decline in serum Calcium (Ca) as a result of dermal Ca loss stimulates bone resorption via an increase in Parathyroid Hormone (PTH). Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Treadmill Exercise and Magnitude of Ca loss during Exercise at 26 degrees Celcius
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jan 2018
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged 60-80 y
Who cannot join
- Use of medications in the past 6 months known to affect bone metabolism (e.g., bisphosphonates, thiazide diuretics, oral glucocorticoids)
- BMD t score < -2.5 at the total hip or lumbar spine
- Known disease or condition associated with intestinal malabsorption
- Moderate or severe renal impairment defined as an estimated glomerular filtration rate of <60 mL/min/1.73m2 based on the MDRD equation
- Chronic hepatobiliary disease, defined as liver function tests (AST, ALT) >1.5 times the upper limit of normal; if such values are obtained on initial screening and thought to be transient in nature, repeated testing will be allowed
- Thyroid dysfunction, defined as an ultrasensitive TSH <0.5 or >5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement
Show all 12Show fewer
- Serum calcium <8.5 or >10.3 mg/dL
- Serum 25(OH)D <20 ng/mL; volunteers with abnormal serum 25(OH)D values may be re-considered for participation in the study if serum 25(OH)D is >20 ng/mL after vitamin D supplementation
- Uncontrolled hypertension defined as resting systolic BP >150 mmHg or diastolic BP>90 mmHg; participants who do not meet these criteria at first screening will be re-evaluated, including after follow-up evaluation by the PCP with initiation or adjustment of anti-hypertensive medications
- History of type 1 or type 2 diabetes
- Cardiovascular disease; 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) without follow-up evaluation will be cause for exclusion; follow-up evaluation must include diagnostic testing (e.g., stress echocardiogram or thallium stress test) with interpretation by a cardiologist
- Diagnosis or history of asthma
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Exercise that causes a decline in serum Calcium (Ca) as a result of dermal Ca loss stimulates bone resorption via an increase in Parathyroid Hormone (PTH).
Read the detailed description
Determine whether the magnitude of dermal Ca loss (i.e., sweating) during exercise is a determinant of the decline in iCa and increases in PTH and carboxy-terminal collagen crosslinks (CTX; marker of bone resorption). The proposed experiment will address this by manipulating the rate of dermal Ca loss (moderate vs high sweating rate) to determine whether this is the trigger for the cascade described in Figure 1. This will be achieved by having participants perform two identical exercise bouts under different thermal conditions (warm vs cool).
- Conditions
- Osteoporosis
- Being tested
- Treadmill Exercise, Magnitude of Ca loss during Exercise at 26 degrees Celcius
- Keywords
- parathyroid hormone (PTH), bone mineral density (BMD)
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill ExerciseProcedure or surgery
2 (two) 1-hour of vigorous exercise bouts under different thermal conditions
Magnitude of Ca loss during Exercise at 26 degrees CelciusProcedure or surgery
Blood samples at 15-min intervals starting 15 min before exercise and ending 60 min after exercise
| Study group | Role | What they receive |
|---|---|---|
| Treadmill Exercise | Active comparator | 2 (two) 1-hour of vigorous exercise bouts under different thermal conditions, one at 16 degrees C and one at 26 degrees C. Receives: Procedure: Treadmill Exercise |
| Magnitude of Ca loss during Exercise at 26 degrees Celcius | Experimental | Blood samples at 15-min intervals starting 15 min before exercise and ending 60 min after exercise. Receives: Procedure: Magnitude of Ca loss during Exercise at 26 degrees Celcius |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Parathyroid Hormone (PTH)
PTH will be measured during baseline, throughout exercise, and during recovery at regular intervals. We are looking to see how PTH changes over the course of the exercise and recovery period in both the warm and cool conditions. We anticipate that PTH will be higher in the warm condition versus the cool. We expect that men and women will respond similarly.
Measured: 60 minutes of exercise and 2 hours of recovery
Change C-Telopeptide (CTX)
CTX will be measured during baseline, throughout exercise, and during recovery at regular intervals. We are looking to see how PTH changes over the course of the exercise and recovery period in both the warm and cool conditions. We anticipate that CTX will be higher during exercise and recovery in the warm condition versus the cool.
Measured: 60 minutes of exercise and 2 hours of recovery
Change in Serum Ionized Calcium (iCa)
iCa will be measured during baseline, throughout exercise, and during recovery at regular intervals. We are looking to see how PTH changes over the course of the exercise and recovery period in both the warm and cool conditions. We expect that serum iCa will be higher in the cool condition versus the warm.
Measured: 60 minutes of exercise
Change in Total Ca
Total Ca will be measured during baseline, throughout exercise, and during recovery at regular intervals. We are looking to see how PTH changes over the course of the exercise and recovery period in both the warm and cool conditions.
Measured: 60 minutes of exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2017
- Study completionJan 2018
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 Colorado, DenverThe 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
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah J Wherry, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468817
- Sponsor's protocol ID
- 15-0250
- Status last verified
- Mar 2018
- First submitted
- 2 Jun 2015
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTH And Calcium Responses to Exercise (PACE) in Older Adults
- ClinicalTrials.gov ID
- NCT02468817
- Acronym / sponsor ID
- 15-0250
- Conditions
- Osteoporosis
- Keywords
- parathyroid hormone (PTH), bone mineral density (BMD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 11 Jun 2015 (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.
Exercise that causes a decline in serum Calcium (Ca) as a result of dermal Ca loss stimulates bone resorption via an increase in Parathyroid Hormone (PTH).
Detailed description
Determine whether the magnitude of dermal Ca loss (i.e., sweating) during exercise is a determinant of the decline in iCa and increases in PTH and carboxy-terminal collagen crosslinks (CTX; marker of bone resorption). The proposed experiment will address this by manipulating the rate of dermal Ca loss (moderate vs high sweating rate) to determine whether this is the trigger for the cascade described in Figure 1. This will be achieved by having participants perform two identical exercise bouts under different thermal conditions (warm vs cool).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill Exercise | Active comparator | Procedure: Treadmill Exercise2 (two) 1-hour of vigorous exercise bouts under different thermal conditions, one at 16 degrees C and one at 26 degrees C. |
| Magnitude of Ca loss during Exercise at 26 degrees Celcius | Experimental | Procedure: Magnitude of Ca loss during Exercise at 26 degrees CelciusBlood samples at 15-min intervals starting 15 min before exercise and ending 60 min after exercise. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults aged 60-80 y
Key exclusion criteria (12 listed)
- Use of medications in the past 6 months known to affect bone metabolism (e.g., bisphosphonates, thiazide diuretics, oral glucocorticoids)
- BMD t score < -2.5 at the total hip or lumbar spine
- Known disease or condition associated with intestinal malabsorption
- Moderate or severe renal impairment defined as an estimated glomerular filtration rate of <60 mL/min/1.73m2 based on the MDRD equation
- Chronic hepatobiliary disease, defined as liver function tests (AST, ALT) >1.5 times the upper limit of normal; if such values are obtained on initial screening and thought to be transient in nature, repeated testing will be allowed
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 |
|---|---|---|
| Treadmill Exercise2 (two) 1-hour of vigorous exercise bouts under different thermal conditions | Procedure or surgery | Treadmill Exercise |
| Magnitude of Ca loss during Exercise at 26 degrees CelciusBlood samples at 15-min intervals starting 15 min before exercise and ending 60 min after exercise | Procedure or surgery | Magnitude of Ca loss during Exercise at 26 degrees Celcius |
Primary outcome
Change in Parathyroid Hormone (PTH)
Time frame: 60 minutes of exercise and 2 hours of recovery
PTH will be measured during baseline, throughout exercise, and during recovery at regular intervals. We are looking to see how PTH changes over the course of the exercise and recovery period in both the warm and cool conditions. We anticipate that PTH will be higher in the warm condition versus the cool. We expect that men and women will respond similarly.
Change C-Telopeptide (CTX)
Time frame: 60 minutes of exercise and 2 hours of recovery
CTX will be measured during baseline, throughout exercise, and during recovery at regular intervals. We are looking to see how PTH changes over the course of the exercise and recovery period in both the warm and cool conditions. We anticipate that CTX will be higher during exercise and recovery in the warm condition versus the cool.
Change in Serum Ionized Calcium (iCa)
Time frame: 60 minutes of exercise
iCa will be measured during baseline, throughout exercise, and during recovery at regular intervals. We are looking to see how PTH changes over the course of the exercise and recovery period in both the warm and cool conditions. We expect that serum iCa will be higher in the cool condition versus the warm.
Change in Total Ca
Time frame: 60 minutes of exercise
Total Ca will be measured during baseline, throughout exercise, and during recovery at regular intervals. We are looking to see how PTH changes over the course of the exercise and recovery period in both the warm and cool conditions.
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 14 Mar 2018.
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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
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill Exercise and Magnitude of Ca loss during Exercise at 26 degrees Celcius in people with Osteoporosis, run by University of Colorado, Denver 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 1 inclusion and 12 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 14 Mar 2018. 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?
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?
Change in Parathyroid Hormone (PTH) (time frame: 60 minutes of exercise and 2 hours of recovery). The study lists 4 primary outcomes in all. 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 14 Mar 2018.