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

Completed · Not applicable

Conditions studied: Osteoporosis

In brief

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).

Key facts

Study ID

NCT02468817

Run by

University of Colorado, Denver

People needed

12

Starts

2015-08-01

Expected to finish

2018-01-01

Last updated by the study team

2018-03-14

Who can join

Age: 60 and older, up to 80. Sex: any. Healthy volunteers: accepted.

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
• 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

Where it is running

• University of Colorado Hospital — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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