search
Back to results

Parameters of Exercise to Prevent Osteoporosis (OSTEOPOROSISEX)

Primary Purpose

Osteoporosis, Postmenopausal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteoporosis, Postmenopausal

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Michigan Clinical Research Unit United States

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

40 minute up trial

40 minute down trial

Two 20 minute up trials

Two 20 min down trials

Sedentary trial

Arm Description

Subjects were subjected to 40 minutes of treadmill exercise at a 6 degree incline and at 75% of maximal effort between 8:00 and 8:40 am. Isocaloric meals were provided at 7:00, 13:00. and 19:00 h.

Subjects were subjected to 40 minutes of treadmill exercise at a 6 degree decline and at 45% of maximal effort between 8:00 and 8:40 am. Isocaloric meals were provided at 7:00, 13:00. and 19:00 h.

Subjects were subjected to two 20 minutes of treadmill exercise separated by 7 h at a 6 degree incline and at 75% of maximal effort, the first one between 8:00 and 8:40 am and the second one between 15:00 and 15:20 h..Isocaloric meals were provided at 7:00, 13:00. and 19:00 h.

Subjects were subjected to two 20 minutes of treadmill exercise separated by 7 h at a 6 degree incline and at 45% of maximal effort , the first one between 8:00 and 8:40 am and the second one between 15:00 and 15:20 h. Isocaloric meals were provided at 7:00, 13:00. and 19:00 h.

No exercise day with isocaloric meals provided at 7:00, 13:00. and 19:00 h.

Outcomes

Primary Outcome Measures

Ground reaction forces
Sum of pressures on mechanosensitive Novel-Pedar shoe insoles
Serum osteocalcin
Concentration of osteocalcin measured in serum samples
Serum CICP (c-terminal propeptide of type 1 collagen
Concentration of CICP measured in serum samples
Serum CTX (c-terminal telopeptide of type 1 collagen
Concentration of CTX measured in serum samples

Secondary Outcome Measures

Relative aerobic capacity
Percent of maximal aerobic capacity used during uphill and downhill exercise
Serum insulin
Concentration of insulin measured in serum samples
Serum cortisol
Concentration of cortisol measured in serum samples
Serum GH (growth hormone)
Concentration of GH measured in serum samples
serum PTH (parathyroid hormone)
Concentration of PTH measured in serum samples

Full Information

First Posted
August 19, 2019
Last Updated
August 20, 2019
Sponsor
University of Michigan
Collaborators
University of Wisconsin, La Crosse, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT04063813
Brief Title
Parameters of Exercise to Prevent Osteoporosis
Acronym
OSTEOPOROSISEX
Official Title
Parameters of Exercise to Prevent Osteoporosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 15, 2007 (Actual)
Primary Completion Date
August 19, 2010 (Actual)
Study Completion Date
August 19, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
University of Wisconsin, La Crosse, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 .
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Five parallel groups, matched for age and BMI, where exercise was applied at 6o uphill or 6o downhill either as one 40-min morning bout or as two 20-min half bouts distributed 7 h apart. A sedentary group served as a control for the four exercise groups.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
40 minute up trial
Arm Type
Experimental
Arm Description
Subjects were subjected to 40 minutes of treadmill exercise at a 6 degree incline and at 75% of maximal effort between 8:00 and 8:40 am. Isocaloric meals were provided at 7:00, 13:00. and 19:00 h.
Arm Title
40 minute down trial
Arm Type
Experimental
Arm Description
Subjects were subjected to 40 minutes of treadmill exercise at a 6 degree decline and at 45% of maximal effort between 8:00 and 8:40 am. Isocaloric meals were provided at 7:00, 13:00. and 19:00 h.
Arm Title
Two 20 minute up trials
Arm Type
Experimental
Arm Description
Subjects were subjected to two 20 minutes of treadmill exercise separated by 7 h at a 6 degree incline and at 75% of maximal effort, the first one between 8:00 and 8:40 am and the second one between 15:00 and 15:20 h..Isocaloric meals were provided at 7:00, 13:00. and 19:00 h.
Arm Title
Two 20 min down trials
Arm Type
Experimental
Arm Description
Subjects were subjected to two 20 minutes of treadmill exercise separated by 7 h at a 6 degree incline and at 45% of maximal effort , the first one between 8:00 and 8:40 am and the second one between 15:00 and 15:20 h. Isocaloric meals were provided at 7:00, 13:00. and 19:00 h.
Arm Title
Sedentary trial
Arm Type
Active Comparator
Arm Description
No exercise day with isocaloric meals provided at 7:00, 13:00. and 19:00 h.
Intervention Type
Behavioral
Intervention Name(s)
Experimental: 40 minute up trial
Other Intervention Name(s)
40 minutes of uphill exercise divided into two 20-minute trials separated by 7 h
Intervention Type
Behavioral
Intervention Name(s)
Experimental: 40 minute down trial
Other Intervention Name(s)
40 minutes of downhill exercise divided into two 20-minute trials separated by 7 h
Intervention Type
Behavioral
Intervention Name(s)
Experimental: Two 20 minute up trials
Other Intervention Name(s)
40 minutes of uphill exercise separated in two 20-min bouts 7 h apart
Intervention Type
Behavioral
Intervention Name(s)
Experimental: Two 20 min down trials
Other Intervention Name(s)
40 minutes of uphill exercise separated in two 20-min bouts 7 h apart
Intervention Type
Behavioral
Intervention Name(s)
Active Comparator: Sedentary trial
Other Intervention Name(s)
A control no-exercise trial
Primary Outcome Measure Information:
Title
Ground reaction forces
Description
Sum of pressures on mechanosensitive Novel-Pedar shoe insoles
Time Frame
During last 5 minutes of treadmill walking
Title
Serum osteocalcin
Description
Concentration of osteocalcin measured in serum samples
Time Frame
Hourly blood draws between 8:00 and 22:00 hours
Title
Serum CICP (c-terminal propeptide of type 1 collagen
Description
Concentration of CICP measured in serum samples
Time Frame
Hourly blood draws between 8:00 and 22:00 hours
Title
Serum CTX (c-terminal telopeptide of type 1 collagen
Description
Concentration of CTX measured in serum samples
Time Frame
Hourly blood draws between 8:00 and 22:00 hours
Secondary Outcome Measure Information:
Title
Relative aerobic capacity
Description
Percent of maximal aerobic capacity used during uphill and downhill exercise
Time Frame
1 day (measured throughout treadmill exercise bouts)
Title
Serum insulin
Description
Concentration of insulin measured in serum samples
Time Frame
Hourly blood draws between 8:00 and 22:00 hours
Title
Serum cortisol
Description
Concentration of cortisol measured in serum samples
Time Frame
Hourly blood draws between 8:00 and 22:00 hours
Title
Serum GH (growth hormone)
Description
Concentration of GH measured in serum samples
Time Frame
Hourly blood draws between 8:00 and 22:00 hours
Title
serum PTH (parathyroid hormone)
Description
Concentration of PTH measured in serum samples
Time Frame
Hourly blood draws between 8:00 and 22:00 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
postmenopausal women
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Michigan Clinical Research Unit United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Parameters of Exercise to Prevent Osteoporosis

We'll reach out to this number within 24 hrs