OsteoporosismMRINCT01049191
Bone Microarchitecture in Women With and Without Fracture
An observational study of Osteoporosis and Fracture, run by University of Wisconsin, Madison at 2 sites in United States.
Trial summary
Osteoporosis is a common disorder of compromised bone strength causing 40-50% of women and ~25% of men to sustain fragility fractures during their lifetime. The reduction of bone strength in osteoporotic people results from loss of bone density and deterioration of bone quality. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Fracture
- How many people
- 78 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2008to May 2010
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Seventy-two postmenopausal volunteers age ≥ 50 years will be recruited from existing databases of ~3500 women with expressed interested in research. All will have normal BMD or osteopenia (T-score > -2.5 at the L1-4 spine, proximal femur and 1/3rd radius) by DXA. Thirty-six will have sustained a "fragility" fracture of the spine, hip or wrist, defined as a fracture occurring with everyday activities including a fall from standing height or less. Historical radiographic documentation of fracture will be obtained. Thirty-six women without fracture will serve as age- race- and BMD-matched controls. Age will be matched to within 6 months; BMD in grams/cm2 at the non-dominant ultra-distal radius will be matched to within 5%.
Who may be able to join
- Postmenopausal women volunteers age ≥ 50 years
- normal BMD or osteopenia (T-score > -2.5 at the L1-4 spine, proximal femur and 1/3rd radius) by DXA.
- sustained a "fragility" fracture of the spine, hip or wrist, defined as a fracture occurring with everyday activities including a fall from standing height or less.
- Historical radiographic documentation of fracture will be obtained.
- Criteria as defined above without prior fracture, age and bone density matching a participant in the fracture group
Who cannot join
- metabolic bone disease
- malignancy
- renal failure
- use of medications which alter bone turnover
- diseases/conditions leading to the non-dominant arm disuse
- contraindications to MRI.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, 53705
University of Wisconsin Osteoporosis Clinical and Research Program
Madison, Wisconsin, 53705
About this study
Osteoporosis is a common disorder of compromised bone strength causing 40-50% of women and ~25% of men to sustain fragility fractures during their lifetime. The reduction of bone strength in osteoporotic people results from loss of bone density and deterioration of bone quality. Bone quality is a complex amalgamation including macro- and micro-architecture, mineralization, turnover and damage accumulation. Currently, medications to reduce fracture risk are prescribed primarily on the basis of bone mineral density (BMD) measurement. Unfortunately, currently available BMD measurement technologies do not detect the aforementioned properties of bone quality; as such, less than half of individuals who sustain osteoporotic fractures are classified as "osteoporotic" by currently available diagnostic tools. Clearly, measures to enhance identification of those at high fracture risk are needed. High-resolution magnetic resonance imaging (HR-MRI) technology, such as that provided by MicroMRI, Inc., has outstanding potential to be such a tool. Therefore, our long-term goal is to evaluate and optimize the use of HR-MRI in fracture risk prediction; this pilot work is an essential step in attaining this goal.
This research will investigate 72 postmenopausal women with normal or osteopenic BMD by dual-energy x-ray absorptiometry (DXA), 36 with prior low-trauma fractures will be compared with 36 age-, race- and BMD matched women without fracture. We hypothesize that 1.) Women with fractures will have evidence of microarchitectural deterioration on HR-MRI and 2.) Newly developed, more rapid MRI sequences designed at the UW will provide similar trabecular microstructure information more rapidly than the currently used, albeit investigational, technology produced by MicroMRI, Inc.
Our specific aims are to a) Evaluate differences in MicroMRI parameters of trabecular microstructure (bone volume fraction, trabecular thickness, surface/curve ratio and erosion index) between age-, race- and BMD-matched postmenopausal women with and without fracture; b.) Correlate T2* relaxation time (a rapid indirect MRI measure of trabecular density and microstructure) with BMD measured by DXA, and microstructural parameters measured by MicroMRI. As an exploratory aim we will investigate HR-MRI parameters of trabecular microstructure obtained using a newly developed, rapid MRI sequence referred to as IDEAL-FSE with parameters obtained using the currently available MicroMRI, Inc. sequence.
- Conditions
- Osteoporosis, Fracture
- Keywords
- Osteoporosis, Fracture, microMRI, Bone architecture, Bone matrix, Bone and Bones, Magnetic Resonance Imaging
- Medical subject headings
- Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fracture | Subjects experiencing a prior osteoporotic fracture. | |
| Control | These will be age and bone density matched controls to the fracture group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate difference in MicroMRI parameters of trabecular microstructure (bone volume, surface/curve ratio and erosion index) between age-, race- and BMD-matched postmenopausal women with and without fracture.
Measured: 18 months
Secondary outcomes (1)
Correlate T2* relaxation time (a rapid indirect MRI measure of trabecular density and microstructure) with BMD measured by DXA, and microstructural parameters measured by MicroMRI.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startOct 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Kijowski, MD, Principal investigator, University of Wisconsin Department of RadiologyNeil C Binkley, MD, Study director, University of Wisconsin Osteoporosis Clinical Research CenterMichael J Tuite, MD, Study director, University of Wisconsin Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049191
- Sponsor's protocol ID
- 2008-0177
- Acronym
- mMRI
- Status last verified
- Jul 2010
- First submitted
- 12 Jan 2010
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Microarchitecture in Women With and Without Fracture
- ClinicalTrials.gov ID
- NCT01049191
- Acronym / sponsor ID
- mMRI / 2008-0177
- Conditions
- Osteoporosis, Fracture
- Keywords
- Osteoporosis, Fracture, microMRI, Bone architecture, Bone matrix, Bone and Bones, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 14 Jan 2010 (estimated)
- 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.
Osteoporosis is a common disorder of compromised bone strength causing 40-50% of women and ~25% of men to sustain fragility fractures during their lifetime. The reduction of bone strength in osteoporotic people results from loss of bone density and deterioration of bone quality. Bone quality is a complex amalgamation including macro- and micro-architecture, mineralization, turnover and damage accumulation. Currently, medications to reduce fracture risk are prescribed primarily on the basis of bone mineral density (BMD) measurement. Unfortunately, currently available BMD measurement technologies do not detect the aforementioned properties of bone quality; as such, less than half of individuals who sustain osteoporotic fractures are classified as "osteoporotic" by currently available diagnostic tools. Clearly, measures to enhance identification of those at high fracture risk are needed. High-resolution magnetic resonance imaging (HR-MRI) technology, such as that provided by MicroMRI, Inc., has outstanding potential to be such a tool. Therefore, our long-term goal is to evaluate and optimize the use of HR-MRI in fracture risk prediction; this pilot work is an essential step in attaining this goal.
This research will investigate 72 postmenopausal women with normal or osteopenic BMD by dual-energy x-ray absorptiometry (DXA), 36 with prior low-trauma fractures will be compared with 36 age-, race- and BMD matched women without fracture. We hypothesize that 1.) Women with fractures will have evidence of microarchitectural deterioration on HR-MRI and 2.) Newly developed, more rapid MRI sequences designed at the UW will provide similar trabecular microstructure information more rapidly than the currently used, albeit investigational, technology produced by MicroMRI, Inc.
Our specific aims are to a) Evaluate differences in MicroMRI parameters of trabecular microstructure (bone volume fraction, trabecular thickness, surface/curve ratio and erosion index) between age-, race- and BMD-matched postmenopausal women with and without fracture; b.) Correlate T2* relaxation time (a rapid indirect MRI measure of trabecular density and microstructure) with BMD measured by DXA, and microstructural parameters measured by MicroMRI. As an exploratory aim we will investigate HR-MRI parameters of trabecular microstructure obtained using a newly developed, rapid MRI sequence referred to as IDEAL-FSE with parameters obtained using the currently available MicroMRI, Inc. sequence.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fracture | – | –Subjects experiencing a prior osteoporotic fracture. |
| Control | – | –These will be age and bone density matched controls to the fracture group. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Seventy-two postmenopausal volunteers age ≥ 50 years will be recruited from existing databases of ~3500 women with expressed interested in research. All will have normal BMD or osteopenia (T-score > -2.5 at the L1-4 spine, proximal femur and 1/3rd radius) by DXA. Thirty-six will have sustained a "fragility" fracture of the spine, hip or wrist, defined as a fracture occurring with everyday activities including a fall from standing height or less. Historical radiographic documentation of fracture will be obtained. Thirty-six women without fracture will serve as age- race- and BMD-matched controls. Age will be matched to within 6 months; BMD in grams/cm2 at the non-dominant ultra-distal radius will be matched to within 5%.
Key inclusion criteria (5 listed)
- Postmenopausal women volunteers age ≥ 50 years
- normal BMD or osteopenia (T-score > -2.5 at the L1-4 spine, proximal femur and 1/3rd radius) by DXA.
- sustained a "fragility" fracture of the spine, hip or wrist, defined as a fracture occurring with everyday activities including a fall from standing height or less.
- Historical radiographic documentation of fracture will be obtained.
- Criteria as defined above without prior fracture, age and bone density matching a participant in the fracture group
Key exclusion criteria (6 listed)
- metabolic bone disease
- malignancy
- renal failure
- use of medications which alter bone turnover
- diseases/conditions leading to the non-dominant arm disuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate difference in MicroMRI parameters of trabecular microstructure (bone volume, surface/curve ratio and erosion index) between age-, race- and BMD-matched postmenopausal women with and without fracture.
Time frame: 18 months
1 secondary outcome
Correlate T2* relaxation time (a rapid indirect MRI measure of trabecular density and microstructure) with BMD measured by DXA, and microstructural parameters measured by MicroMRI.
Time frame: 18 months
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 5 Oct 2015.
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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.
Richard Kijowski, MD principal investigator
University of Wisconsin Department of Radiology
Neil C Binkley, MD study director
University of Wisconsin Osteoporosis Clinical Research Center
Michael J Tuite, MD study director
University of Wisconsin Department of Radiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Fracture, run by University of Wisconsin, Madison at 2 sites 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 5 inclusion and 6 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 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Evaluate difference in MicroMRI parameters of trabecular microstructure (bone volume, surface/curve ratio and erosion index) between age-, race- and BMD-matched postmenopausal women with and without fracture. (time frame: 18 months). 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 5 Oct 2015.