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OpenTrials
Completed

NCT Number: NCT02580604

PTH And Calcium Responses to Exercise in Older Adults Experiment 2 (PACE Sr. 2)

Declines in serum calcium during exercise may cause increases in markers of bone resorption. This study will determine if preventing the decline serum ionized calcium experienced at the onset of exercise through the use of a "calcium clamp" also prevents increases in blood biomarkers associated with bone resorption.

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Key information

Age range

60 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

About this study

Participants will undergo two identical walking exercise sessions on a treadmill. One session will occur until continuous calcium infusion and the other will be under continuous saline infusion. C-telopeptide, parathyroid hormone, total calcium, and serum ionized calcium will be monitored to distinguish differences in bone activity under the two conditions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults aged 60-80 y
  • Currently taking a bisphosphonate medication

Exclusion criteria

  • Use of medications (other than bisphosphonates) in the past 6 months known to affect bone metabolism (e.g., thiazide diuretics, oral glucocorticoids)
  • Bone Mineral Density (BMD) t score < -3.0 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 Modified Diet in Renal Disease (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

Treatment and study plan

Calcium Chloride/Calcium Gluconate

Drug

Calcium (as either calcium chloride or calcium gluconate in half normal saline) will be delivered via IV during exercise to keep serum ionized calcium levels above baseline. The clamp is modeled after the hyperglycemic glucose clamp.

Half-normal saline

Drug

This is the placebo comparative infusion. Half-normal saline will be infused at the second collection visit following the identical infusion schedule determined during the calcium infusion visit.

Primary outcomes

  1. Change in Parathyroid Hormone (PTH)

    Time frame: baseline, 60 minutes

    Change in PTH will be measured from baseline to end of exercise

Secondary outcomes

  1. Change in C-telopeptide (CTX)

    Time frame: baseline, 60 minutes

    Change in CTX will be measured from baseline to the end of 60 minutes of exercise

  2. Change in Ionized Calcium

    Time frame: baseline, 60 minutes

    Change in ionized calcium will be measured from baseline to the end of 60 minutes of exercise

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2015
Primary completion
2024
Study completion
2025
First posted
Oct 20, 2015
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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