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| ID | Type | Description | Link |
|---|---|---|---|
| UM1TR004399 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium Infusion followed by Saline Infusion | Experimental | All participants will have a continuous calcium infusion during exercise at their first collection visit. The second collection visit will always be a volume-matched half-normal saline infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Parathyroid Hormone (PTH) | Change in PTH will be measured from baseline to end of exercise | baseline, 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in C-telopeptide (CTX) | Change in CTX will be measured from baseline to the end of 60 minutes of exercise | baseline, 60 minutes |
| Change in Ionized Calcium | Change in ionized calcium will be measured from baseline to the end of 60 minutes of exercise |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah J Wherry, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcium Infusion First, Saline Infusion Second | Continuous calcium infusion during exercise 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. The second infusion will be half-normal saline following the same infusion schedule and dosing as the calcium infusion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calcium First |
| |||||||||||||
| Saline Second |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Calcium Infusion | Continuous calcium infusion during exercise |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Parathyroid Hormone (PTH) | Change in PTH will be measured from baseline to end of exercise | Posted | Mean | 95% Confidence Interval | pg/mL | baseline, 60 minutes |
|
|
12 weeks
This study was not intended to treat or prevent any disease/illness. All participants were generally healthy at time of enrollment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calcium Infusion | Continuous calcium infusion during exercise 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarah Wherry | University of Colorado Anschutz Medical Campus | 303-724-1927 | sarah.wherry@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2024 | Jun 5, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D002122 | Calcium Chloride |
| D002125 | Calcium Gluconate |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
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| 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. |
|
| baseline, 60 minutes |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in C-telopeptide (CTX) | Change in CTX will be measured from baseline to the end of 60 minutes of exercise | Posted | Mean | 95% Confidence Interval | ng/mL | baseline, 60 minutes |
|
|
|
| Secondary | Change in Ionized Calcium | Change in ionized calcium will be measured from baseline to the end of 60 minutes of exercise | Posted | Mean | 95% Confidence Interval | mg/dL | baseline, 60 minutes |
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|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Saline Infusion | Continuous saline infusion during exercise Placebo: Saline Infusion | 0 | 12 | 0 | 12 | 0 | 12 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D017606 |
| Chlorine Compounds |
| D005942 | Gluconates |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |