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Completed

NCT Number: NCT04063813

Parameters of Exercise to Prevent Osteoporosis

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 .

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Key information

Age range

50 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Michigan Clinical Research Unit United States

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental: 40 minute up trial

Behavioral

Other names: 40 minutes of uphill exercise divided into two 20-minute trials separated by 7 h

Experimental: 40 minute down trial

Behavioral

Other names: 40 minutes of downhill exercise divided into two 20-minute trials separated by 7 h

Experimental: Two 20 minute up trials

Behavioral

Other names: 40 minutes of uphill exercise separated in two 20-min bouts 7 h apart

Experimental: Two 20 min down trials

Behavioral

Other names: 40 minutes of uphill exercise separated in two 20-min bouts 7 h apart

Active Comparator: Sedentary trial

Behavioral

Other names: A control no-exercise trial

Primary outcomes

  1. Ground reaction forces

    Time frame: During last 5 minutes of treadmill walking

    Sum of pressures on mechanosensitive Novel-Pedar shoe insoles

  2. Serum osteocalcin

    Time frame: Hourly blood draws between 8:00 and 22:00 hours

    Concentration of osteocalcin measured in serum samples

  3. Serum CICP (c-terminal propeptide of type 1 collagen

    Time frame: Hourly blood draws between 8:00 and 22:00 hours

    Concentration of CICP measured in serum samples

  4. Serum CTX (c-terminal telopeptide of type 1 collagen

    Time frame: Hourly blood draws between 8:00 and 22:00 hours

    Concentration of CTX measured in serum samples

Secondary outcomes

  1. Relative aerobic capacity

    Time frame: 1 day (measured throughout treadmill exercise bouts)

    Percent of maximal aerobic capacity used during uphill and downhill exercise

  2. Serum insulin

    Time frame: Hourly blood draws between 8:00 and 22:00 hours

    Concentration of insulin measured in serum samples

  3. Serum cortisol

    Time frame: Hourly blood draws between 8:00 and 22:00 hours

    Concentration of cortisol measured in serum samples

  4. Serum GH (growth hormone)

    Time frame: Hourly blood draws between 8:00 and 22:00 hours

    Concentration of GH measured in serum samples

  5. serum PTH (parathyroid hormone)

    Time frame: Hourly blood draws between 8:00 and 22:00 hours

    Concentration of PTH measured in serum samples

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Wisconsin, La Crosse

Registry information

Acronym: OSTEOPOROSISEX

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 21, 2019
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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