Back to resultsPTH And Calcium Responses to Exercise in Older Adults Experiment 2 (PACE Sr. 2)
Primary Purpose
Osteoporosis
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Calcium Chloride/Calcium Gluconate
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis
Eligibility 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
Sites / Locations
- University of Colorado HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Calcium Infusion
Saline Infusion
Arm Description
Continuous calcium infusion during exercise
Continuous saline infusion during exercise
Outcomes
Primary Outcome Measures
Change in Parathyroid Hormone (PTH)
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
Change in C-telopeptide (CTX)
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.
Change in Total Calcium (Ca)
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.
Full Information
NCT ID
NCT02580604
First Posted
October 16, 2015
Last Updated
September 18, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Center for Advancing Translational Sciences (NCATS)
1. Study Identification
Unique Protocol Identification Number
NCT02580604
Brief Title
PTH And Calcium Responses to Exercise in Older Adults Experiment 2 (PACE Sr. 2)
Official Title
PTH And Calcium Responses to Exercise in Older Adults Experiment 2 (PACE Sr. 2)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2015 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Center for Advancing Translational Sciences (NCATS)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Calcium Infusion
Arm Type
Experimental
Arm Description
Continuous calcium infusion during exercise
Arm Title
Saline Infusion
Arm Type
Placebo Comparator
Arm Description
Continuous saline infusion during exercise
Intervention Type
Drug
Intervention Name(s)
Calcium Chloride/Calcium Gluconate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline Infusion
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. 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.
Time Frame
At baseline, through 60 minutes of exercise, and during 4 hours of recovery
Secondary Outcome Measure Information:
Title
Change in C-telopeptide (CTX)
Description
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.
Time Frame
At baseline, through 60 minutes of exercise, and during 4 hours of recovery
Title
Change in Total Calcium (Ca)
Description
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.
Time Frame
At baseline, through 60 minutes of exercise, and during 4 hours of recovery
10. Eligibility
Sex
Female
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah J Wherry, PhD
Phone
303-724-1927
Email
sarah.wherry@ucdenver.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Toby Wellington, BS
Phone
720-848-6376
Email
Toby.Wellington@ucdenver.edu
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Wherry, PhD
12. IPD Sharing Statement
Learn more about this trial
PTH And Calcium Responses to Exercise in Older Adults Experiment 2 (PACE Sr. 2)
We'll reach out to this number within 24 hrs