N/A
N=12
PTH And Calcium Responses to Exercise in Older Adults Experiment 2 (PACE Sr. 2)
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT02580604 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Change in Parathyroid Hormone (PTH) — 8.5; 20.0 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Calcium Chloride/Calcium Gluconate (Drug); Half-Normal Saline (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Parathyroid Hormone (PTH) |
8.5; 20.0 | — |
| SECONDARY Change in C-telopeptide (CTX) |
0.01; 0.11 | — |
| SECONDARY Change in Ionized Calcium |
0.07; -0.15 | — |
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.
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 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 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 10.3 mg/dL Serum 25(OH)D 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
Data sourced from ClinicalTrials.gov (NCT02580604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.