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PTH And Calcium Responses to Exercise (PACE) in Older Adults

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ClinicalTrials.gov Identifier: NCT02468817
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Osteoporosis Procedure: Treadmill Exercise Procedure: Magnitude of Ca loss during Exercise at 26 degrees Celcius Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PTH And Calcium Responses to Exercise (PACE) in Older Adults
Study Start Date : August 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : January 2018

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Treadmill Exercise
2 (two) 1-hour of vigorous exercise bouts under different thermal conditions, one at 16 degrees C and one at 26 degrees C.
 Procedure: Treadmill Exercise
2 (two) 1-hour of vigorous exercise bouts under different thermal conditions
Experimental: Magnitude of Ca loss during Exercise at 26 degrees Celcius
Blood samples at 15-min intervals starting 15 min before exercise and ending 60 min after exercise.
 Procedure: Magnitude of Ca loss during Exercise at 26 degrees Celcius
Blood samples at 15-min intervals starting 15 min before exercise and ending 60 min after exercise


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults aged 60-80 y

Exclusion Criteria:

  • 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
  • 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468817


Locations
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United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Sarah J Wherry, PhD University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02468817     History of Changes
Other Study ID Numbers: 15-0250
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Keywords provided by University of Colorado, Denver:
parathyroid hormone (PTH)
bone mineral density (BMD)
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Metabolic Diseases
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs