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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04063813
Other study ID # HUM00007202
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2007
Est. completion date August 19, 2010

Study information

Verified date August 2019
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The principal goal of this study is to determine parameters of walking in terms of peak mechanical vertical force, bout duration, and bout spacing that can preserve or increase bone mineral density (BMD) in postmenopausal women. Release of pulses of parathyroid hormone (PTH), growth hormone (GH), and of markers of bone resorption and bone formation will be used as indicators of the osteogenic effects of a short exposure to exercise. When secreted in pulsatile fashion, GH stimulates osteoblast proliferation, particularly in cortical bone (27, 28). Like GH, the pattern of PTH secretion determines the nature of its effect on bone. When it is secreted in pulsatile manner, PTH contributes to bone formation through activation of bone lining cells, differentiation of osteoprogenitor cells, and suppression of bone cell apoptosis .


Description:

A. Hypotheses and specific aims:

Specific aim 1. Measure plasma concentrations of anabolic hormones (parathyroid hormone (PTH) and growth hormone (GH), at sufficient frequency to define the area under the curve (AUC), and of markers of bone formation (osteocalcin, carboxyterminal propeptide of type 1 procollagen (CICP), and bone-specific alkaline phosphatase (ALKP)), and markers of bone resorption (immunoreactive carboxyterminal telopeptide of type I collagen (CTX)) after 40-minutes of treadmill exercise at the relative intensity of 125% of the ventilatory threshold (VT) corresponding to about 1.78 m/sec (4 miles/h), and two intensities of mechanical loading (724, and 1411 N), in healthy postmenopausal women.

Hypothesis 1. Bone formation, as assessed by increases in markers of bone formation and decreases in markers of bone resorption, will be higher in response to dynamic exercise at a level of mechanical loading that produces increased secretion of PTH and GH than to exercise at other loading intensities.

Specific aim 2. Measure plasma concentrations of anabolic hormones), at sufficient frequency to define the area under the curve (AUC), and of markers of bone formation as in specific aim 1, after two 20-minutes of treadmill exercise, separated by 7 h, at the relative intensity of 125% of the ventilatory threshold (VT) corresponding to about 1.78 m/sec (4 mi/h), and two intensities of mechanical loading (724, and 1411 N), in healthy postmenopausal women.

Hypothesis 2. A 7-hour interval separating the two bouts of exercise will have greater bone anabolic effect than the equivalent volume and intensity of exercise performed in a single bout.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 19, 2010
Est. primary completion date August 19, 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 65 Years
Eligibility Inclusion Criteria:

- Age 50 to 65 years if naturally post-menopausal, or age 47 if surgically postmenopausal

- Dual energy X-ray absorptiometry (DEXA) Z score above -1

- No endocrine or metabolic disease requiring medication except for hormonally corrected hypothyroidism

- No musculo-skeletal disabilities that would preclude treadmill walking

- Normal electrocardiogram (EKG) and heart health history

- BMI between 24 and 30

- Hematocrit above 32 %

- No hormone replacement therapy (HRT)

- Personal health provider's Release Letter

Exclusion Criteria:

- Age and BMI outside of the specified range

- Z score below -1

- Medication for presence of metabolic or endocrine disease

- Musculo-skeletal disabilities that would preclude treadmill walking

- Abnormal electrocardiogram (EKG) and heart health history

- Hematocrit below 32%

- Hormone replacement therapy

- Failure to conform to study protocol

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Experimental: 40 minute up trial

Experimental: 40 minute down trial

Experimental: Two 20 minute up trials

Experimental: Two 20 min down trials

Active Comparator: Sedentary trial


Locations

Country Name City State
United States Michigan Clinical Research Unit United States Ann Arbor Michigan

Sponsors (3)

Lead Sponsor Collaborator
University of Michigan National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Wisconsin, La Crosse

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ground reaction forces Sum of pressures on mechanosensitive Novel-Pedar shoe insoles During last 5 minutes of treadmill walking
Primary Serum osteocalcin Concentration of osteocalcin measured in serum samples Hourly blood draws between 8:00 and 22:00 hours
Primary Serum CICP (c-terminal propeptide of type 1 collagen Concentration of CICP measured in serum samples Hourly blood draws between 8:00 and 22:00 hours
Primary Serum CTX (c-terminal telopeptide of type 1 collagen Concentration of CTX measured in serum samples Hourly blood draws between 8:00 and 22:00 hours
Secondary Relative aerobic capacity Percent of maximal aerobic capacity used during uphill and downhill exercise 1 day (measured throughout treadmill exercise bouts)
Secondary Serum insulin Concentration of insulin measured in serum samples Hourly blood draws between 8:00 and 22:00 hours
Secondary Serum cortisol Concentration of cortisol measured in serum samples Hourly blood draws between 8:00 and 22:00 hours
Secondary Serum GH (growth hormone) Concentration of GH measured in serum samples Hourly blood draws between 8:00 and 22:00 hours
Secondary serum PTH (parathyroid hormone) Concentration of PTH measured in serum samples Hourly blood draws between 8:00 and 22:00 hours
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