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

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ClinicalTrials.gov Identifier: NCT02580604
Recruitment Status : Recruiting
First Posted : October 20, 2015
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Calcium Chloride/Calcium Gluconate Drug: Placebo Early Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PTH And Calcium Responses to Exercise in Older Adults Experiment 2 (PACE Sr. 2)
Actual Study Start Date : November 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Calcium Infusion
Continuous calcium infusion during exercise
Drug: Calcium Chloride/Calcium Gluconate
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.

Placebo Comparator: Saline Infusion
Continuous saline infusion during exercise
Drug: Placebo
Saline Infusion




Primary Outcome Measures :
  1. Change in Parathyroid Hormone (PTH) [ Time Frame: At baseline, through 60 minutes of exercise, and during 4 hours of recovery ]
    PTH will be measured during baseline, throughout exercise, and during recovery at regular intervals. The investigators are looking to see how PTH changes over the course of the exercise and recovery period in both the calcium and saline. The investigators anticipate that PTH will be higher in the saline condition versus the calcium. The investigators expect that men and women will respond similarly.


Secondary Outcome Measures :
  1. Change in C-telopeptide (CTX) [ Time Frame: At baseline, through 60 minutes of exercise, and during 4 hours of recovery ]
    CTX will be measured during baseline, throughout exercise, and during recovery at regular intervals. The investigators are looking to see how PTH changes over the course of the exercise and recovery period in both the calcium and saline. The investigators anticipate that CTX will be higher in the saline condition versus the calcium. The investigators expect that men and women will respond similarly.

  2. Change in Total Calcium (Ca) [ Time Frame: At baseline, through 60 minutes of exercise, and during 4 hours of recovery ]
    Total Ca will be measured during baseline, throughout exercise, and during recovery at regular intervals. The investigators are looking to see how Ca changes over the course of the exercise and recovery period in both the calcium and saline conditions.



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580604


Contacts
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Contact: Sarah J Wherry, PhD 720-848-6475 sarah.wherry@ucdenver.edu
Contact: Toby Wellington, BS 720-848-6376 Toby.Wellington@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Sarah Wherry, PhD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Sarah J Wherry, PhD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02580604     History of Changes
Other Study ID Numbers: 15-0878
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium
Calcium, Dietary
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents