Trial Outcomes & Findings for PTH And Calcium Responses to Exercise in Older Adults Experiment 2 (PACE Sr. 2) (NCT NCT02580604)

NCT ID: NCT02580604

Last Updated: 2025-08-13

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: baseline, 60 minutes
• Results posted on: 2025-08-13

Participant Flow

Participant milestones

Measure	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.
Calcium First STARTED	12
Calcium First COMPLETED	12
Calcium First NOT COMPLETED	0
Saline Second STARTED	12
Saline Second COMPLETED	12
Saline Second NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Calcium Infusion n=12 Participants Continuous calcium infusion during exercise
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	65.5 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 60 minutes

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

Outcome measures

Measure	Calcium Infusion n=12 Participants Continuous calcium infusion during exercise	Saline Infusion n=12 Participants Continuous saline infusion during exercise
Change in Parathyroid Hormone (PTH)	8.5 pg/mL Interval 3.5 to 13.4	20.0 pg/mL Interval 11.2 to 28.7

SECONDARY outcome

Timeframe: baseline, 60 minutes

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

Outcome measures

Measure	Calcium Infusion n=12 Participants Continuous calcium infusion during exercise	Saline Infusion n=12 Participants Continuous saline infusion during exercise
Change in C-telopeptide (CTX)	0.01 ng/mL Interval -0.03 to 0.06	0.11 ng/mL Interval 0.03 to 0.18

SECONDARY outcome

Timeframe: baseline, 60 minutes

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

Outcome measures

Measure	Calcium Infusion n=12 Participants Continuous calcium infusion during exercise	Saline Infusion n=12 Participants Continuous saline infusion during exercise
Change in Ionized Calcium	0.07 mg/dL Interval 0.05 to 0.2	-0.15 mg/dL Interval -0.29 to -0.01

Adverse Events

Calcium Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sarah Wherry

University of Colorado Anschutz Medical Campus

Phone: 303-724-1927

Email: sarah.wherry@cuanschutz.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place