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

NCT02468817 | Completed

• 1 other identifier: 15-0250
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoporosis

Keywords

parathyroid hormone (PTH); bone mineral density (BMD)

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  60 minutes of exercise

Study Arms (2)

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.

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.

Procedure: Magnitude of Ca loss during Exercise at 26 degrees Celcius

Interventions

Treadmill Exercise PROCEDURE

2 (two) 1-hour of vigorous exercise bouts under different thermal conditions

Treadmill Exercise

Magnitude of Ca loss during Exercise at 26 degrees Celcius PROCEDURE

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

Magnitude of Ca loss during Exercise at 26 degrees Celcius

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults aged 60-80 y

You may not qualify if:

• 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
• Diagnosis or history of asthma

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sarah J Wherry, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 11, 2015
• Study Start: August 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: January 1, 2018
• Last Updated: March 14, 2018

Record last verified: 2018-03

Locations

US (1)