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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treadmill Exercise
Magnitude of Ca loss during Exercise at 26 degrees Celcius
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring parathyroid hormone (PTH), bone mineral density (BMD)

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Colorado Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treadmill Exercise

Magnitude of Ca loss during Exercise at 26 degrees Celcius

Arm Description

2 (two) 1-hour of vigorous exercise bouts under different thermal conditions, one at 16 degrees C and one at 26 degrees C.

Blood samples at 15-min intervals starting 15 min before exercise and ending 60 min after exercise.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 2, 2015
Last Updated
March 12, 2018
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT02468817
Brief Title
PTH And Calcium Responses to Exercise (PACE) in Older Adults
Official Title
PTH And Calcium Responses to Exercise (PACE) in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
parathyroid hormone (PTH), bone mineral density (BMD)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treadmill Exercise
Arm Type
Active Comparator
Arm Description
2 (two) 1-hour of vigorous exercise bouts under different thermal conditions, one at 16 degrees C and one at 26 degrees C.
Arm Title
Magnitude of Ca loss during Exercise at 26 degrees Celcius
Arm Type
Experimental
Arm Description
Blood samples at 15-min intervals starting 15 min before exercise and ending 60 min after exercise.
Intervention Type
Procedure
Intervention Name(s)
Treadmill Exercise
Intervention Description
2 (two) 1-hour of vigorous exercise bouts under different thermal conditions
Intervention Type
Procedure
Intervention Name(s)
Magnitude of Ca loss during Exercise at 26 degrees Celcius
Intervention Description
Blood samples at 15-min intervals starting 15 min before exercise and ending 60 min after exercise
Primary Outcome Measure Information:
Title
Change in Parathyroid Hormone (PTH)
Description
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.
Time Frame
60 minutes of exercise and 2 hours of recovery
Title
Change C-Telopeptide (CTX)
Description
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.
Time Frame
60 minutes of exercise and 2 hours of recovery
Title
Change in Serum Ionized Calcium (iCa)
Description
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.
Time Frame
60 minutes of exercise
Title
Change in Total Ca
Description
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.
Time Frame
60 minutes of exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah J Wherry, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

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

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