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

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

Tracking Information

• First Submitted Date: June 2, 2015
• First Posted Date: June 11, 2015
• Last Update Posted Date: March 14, 2018
• Study Start Date: August 2015
• Actual Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 21, 2016)

• 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.

Original Primary Outcome Measures (submitted: June 8, 2015)

• 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.
• Chaneg 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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PTH And Calcium Responses to Exercise (PACE) in Older Adults
• Official Title: PTH And Calcium Responses to Exercise (PACE) in Older Adults
• 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).
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Osteoporosis

Intervention

• Procedure: Treadmill Exercise
  2 (two) 1-hour of vigorous exercise bouts under different thermal conditions
• 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

Study Arms

• 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.
  Intervention: Procedure: Treadmill Exercise
• 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.
  Intervention: Procedure: Magnitude of Ca loss during Exercise at 26 degrees Celcius

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 12, 2018): 12
• Original Estimated Enrollment (submitted: June 8, 2015): 32
• Actual Study Completion Date: January 2018
• Actual Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02468817
• Other Study ID Numbers: 15-0250
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Colorado, Denver
• Study Sponsor: University of Colorado, Denver
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sarah J Wherry, PhD; University of Colorado, Denver

• PRS Account: University of Colorado, Denver
• Verification Date: March 2018