Osteoporosis, PostmenopausalOSTEOPOROSISEXNCT04063813
Parameters of Exercise to Prevent Osteoporosis
A study testing Experimental: 40 minute up trial, Experimental: 40 minute down trial and Experimental: Two 20 minute up trials in people with Osteoporosis, Postmenopausal, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Experimental: 40 minute up trial, Experimental: 40 minute down trial and Experimental: Two 20 minute up trials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2007to 19 Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Hematocrit above 32 %
- No hormone replacement therapy (HRT)
- Personal health provider's Release Letter
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Clinical Research Unit United States
Ann Arbor, Michigan, 48109
About this study
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 .
Read the detailed description
- 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.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- 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
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: 40 minute up trialBehavioural
Also called 40 minutes of uphill exercise divided into two 20-minute trials separated by 7 h
Experimental: 40 minute down trialBehavioural
Also called 40 minutes of downhill exercise divided into two 20-minute trials separated by 7 h
Experimental: Two 20 minute up trialsBehavioural
Also called 40 minutes of uphill exercise separated in two 20-min bouts 7 h apart
Experimental: Two 20 min down trialsBehavioural
Also called 40 minutes of uphill exercise separated in two 20-min bouts 7 h apart
Active Comparator: Sedentary trialBehavioural
Also called A control no-exercise trial
| Study group | Role | What they receive |
|---|---|---|
| 40 minute up trial | Experimental | 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. Receives: Behavioral: Experimental: 40 minute up trial |
| 40 minute down trial | Experimental | 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. Receives: Behavioral: Experimental: 40 minute down trial |
| Two 20 minute up trials | Experimental | 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. Receives: Behavioral: Experimental: Two 20 minute up trials |
| Two 20 min down trials | Experimental | 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. Receives: Behavioral: Experimental: Two 20 min down trials |
| Sedentary trial | Active comparator | No exercise day with isocaloric meals provided at 7:00, 13:00. and 19:00 h. Receives: Behavioral: Active Comparator: Sedentary trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ground reaction forces
Sum of pressures on mechanosensitive Novel-Pedar shoe insoles
Measured: During last 5 minutes of treadmill walking
Serum osteocalcin
Concentration of osteocalcin measured in serum samples
Measured: Hourly blood draws between 8:00 and 22:00 hours
Serum CICP (c-terminal propeptide of type 1 collagen
Concentration of CICP measured in serum samples
Measured: Hourly blood draws between 8:00 and 22:00 hours
Serum CTX (c-terminal telopeptide of type 1 collagen
Concentration of CTX measured in serum samples
Measured: Hourly blood draws between 8:00 and 22:00 hours
Secondary outcomes (5)
Relative aerobic capacity
Percent of maximal aerobic capacity used during uphill and downhill exercise
Measured: 1 day (measured throughout treadmill exercise bouts)
Serum insulin
Concentration of insulin measured in serum samples
Measured: Hourly blood draws between 8:00 and 22:00 hours
Serum cortisol
Concentration of cortisol measured in serum samples
Measured: Hourly blood draws between 8:00 and 22:00 hours
Serum GH (growth hormone)
Concentration of GH measured in serum samples
Measured: Hourly blood draws between 8:00 and 22:00 hours
serum PTH (parathyroid hormone)
Concentration of PTH measured in serum samples
Measured: Hourly blood draws between 8:00 and 22:00 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start15 May 2007
- Primary completion19 Aug 2010
- Study completion19 Aug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, La Crosse, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Dr. Katarina Borer, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063813
- Sponsor's protocol ID
- HUM00007202
- Acronym
- OSTEOPOROSISEX
- Status last verified
- Aug 2019
- First submitted
- 19 Aug 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parameters of Exercise to Prevent Osteoporosis
- ClinicalTrials.gov ID
- NCT04063813
- Acronym / sponsor ID
- OSTEOPOROSISEX / HUM00007202
- Conditions
- Osteoporosis, Postmenopausal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- University of Wisconsin, La Crosse, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 May 2007 (actual)
- Primary completion
- 19 Aug 2010 (actual)
- Study completion
- 19 Aug 2010 (actual)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| 40 minute up trial | Experimental | Behavioral: Experimental: 40 minute up trialSubjects 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. |
| 40 minute down trial | Experimental | Behavioral: Experimental: 40 minute down trialSubjects 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. |
| Two 20 minute up trials | Experimental | Behavioral: Experimental: Two 20 minute up trialsSubjects 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. |
| Two 20 min down trials | Experimental | Behavioral: Experimental: Two 20 min down trialsSubjects 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. |
| Sedentary trial | Active comparator | Behavioral: Active Comparator: Sedentary trialNo exercise day with isocaloric meals provided at 7:00, 13:00. and 19:00 h. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: 40 minute up trialAlso: 40 minutes of uphill exercise divided into two 20-minute trials separated by 7 h | Behavioural | 40 minute up trial |
| Experimental: 40 minute down trialAlso: 40 minutes of downhill exercise divided into two 20-minute trials separated by 7 h | Behavioural | 40 minute down trial |
| Experimental: Two 20 minute up trialsAlso: 40 minutes of uphill exercise separated in two 20-min bouts 7 h apart | Behavioural | Two 20 minute up trials |
| Experimental: Two 20 min down trialsAlso: 40 minutes of uphill exercise separated in two 20-min bouts 7 h apart | Behavioural | Two 20 min down trials |
| Active Comparator: Sedentary trialAlso: A control no-exercise trial | Behavioural | Sedentary trial |
Primary outcome
Ground reaction forces
Time frame: During last 5 minutes of treadmill walking
Sum of pressures on mechanosensitive Novel-Pedar shoe insoles
Serum osteocalcin
Time frame: Hourly blood draws between 8:00 and 22:00 hours
Concentration of osteocalcin measured in serum samples
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
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
5 secondary outcomes
Relative aerobic capacity
Time frame: 1 day (measured throughout treadmill exercise bouts)
Serum insulin
Time frame: Hourly blood draws between 8:00 and 22:00 hours
Serum cortisol
Time frame: Hourly blood draws between 8:00 and 22:00 hours
Serum GH (growth hormone)
Time frame: Hourly blood draws between 8:00 and 22:00 hours
serum PTH (parathyroid hormone)
Time frame: Hourly blood draws between 8:00 and 22:00 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: 40 minute up trial, Experimental: 40 minute down trial and Experimental: Two 20 minute up trials in people with Osteoporosis, Postmenopausal, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ground reaction forces (time frame: During last 5 minutes of treadmill walking). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.