Clinical trial NCT02580604: 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
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Osteoporosis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2015-10-20
Enrollment: 35
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Parathyroid Hormone (PTH)
timeFrame: At baseline, through 60 minutes of exercise, and during 4 hours of recovery
Secondary outcomes:
measure: Change in C-telopeptide (CTX)
timeFrame: At baseline, through 60 minutes of exercise, and during 4 hours of recovery
measure: Change in Total Calcium (Ca)
timeFrame: At baseline, through 60 minutes of exercise, and during 4 hours of recovery
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Sarah J Wherry, PhD
role: PRINCIPAL_INVESTIGATOR
References: