OsteoporosisNCT00703417
Does Bone Structure Explain the Increased Fracture Risk in Type II Diabetes Patients? A Pilot Study
An observational study of Osteoporosis, run by University of California, San Francisco at 1 site in United States.
Trial summary
For this cross-sectional case control pilot study 30 women, 55-75 years old with type II diabetes will be recruited. Diabetes will be defined as self-report of diabetes previously diagnosed by a physician, use of hypoglycemic medications, or fasting glucose > 126 mg/dl (7.0mM) in accordance with the American Diabetes… Read more about this study
- Who is it for?
- Ages 55 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- magnetic Resonance Imaging, Computed Tomography and High resolution peripheral quantitative computed tomography
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jul 2009
- 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 55 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 10 healthy postmenopausal women 10 postmenopausal women with Type II Diabetes and without fracture 10 postmenopausal women with Type II Diabetes and with fracture of the long bone of the upper arm, hip, ankle, or foot 10 postmenopausal women with Type II Diabetes with and without fracture
Who may be able to join
- Postmenopausal female, 55-75 years old
- History of Type II diabetes, as defined by the American Diabetes Association for more than 5 years that is either insulin requiring or treated with oral therapies such as sulfonylureas and metformin
- Body mass index (BMI) of 19-35
- Able to move without walkers and without a history of long periods (>3 months) of inactivity
- Additional Inclusion criteria for fracture participants:
- Fractures of the proximal humerus and femur as well as the ankle and foot should have occurred after the onset of diabetes and should have been caused by a low energy trauma such as falling from standing height. All fractures will be verified by radiographs.
Who cannot join
- Severe neuropathic disease such as neurogenic osteoarthropathies (i.e., Charcot joints) of the foot
- Steroid users or have disease conditions that could play a significant role in the development of osteoporosis such as idiopathic osteoporosis, immobilization, hyperparathyroidism, or hyperthyroidism
- Diseases that may affect bone metabolism: alcoholism, chronic drug use, chronic gastrointestinal disease, renal or hepatic impairment
- Chronic treatment with antacids, estrogen, adrenal or anabolic steroids, anticonvulsants, anticoagulants, or pharmacologic doses of Vitamin A supplements 6 months prior
- Diabetic patients on rosiglitazone or pioglitazone medications
- high energy trauma, e.g., due to motor vehicle accidents
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- Pathological fractures of other origin, i.e., tumor, tumor-like lesions as well as focal demineralization visualized on radiographs
- History of fluoride, bisphosphonate, calcitonin or tamoxifen use
- History of unstable cardiovascular disease or uncontrolled hypertension
- MRI contraindications
- Body mass index greater than 35
Trial locations and contacts
1 site in 1 country.
United States1 site
China Basin Imaging Center
San Francisco, California, 94107
About this study
For this cross-sectional case control pilot study 30 women, 55-75 years old with type II diabetes will be recruited. Diabetes will be defined as self-report of diabetes previously diagnosed by a physician, use of hypoglycemic medications, or fasting glucose > 126 mg/dl (7.0mM) in accordance with the American Diabetes Association criteria. The diabetic patient population will be divided into 2 groups: patients with status post low energy fractures of the proximal humerus, the proximal femur, the ankle and the foot (n=10) versus diabetic patients with no fractures or low energy trauma fracture history (n=10). An additional group of 10 diabetic postmenopausal women will be recruited and will have magnetic resonance imaging (MRI) of the lower back only. Caucasian, Asian and Hispanic women will be combined since a previous study suggested that BMD is very similar in these 3 population and that ethnic differences are minimal. In addition a population of 10 age-matched, BMI-matched, race-matched healthy women, without osteoporotic fractures will be examined. In all of these volunteers a medical history will be obtained to ensure good health status and rule out chronic diseases that would have an impact on bone metabolism. Patients will undergo MRI, QCT and high-resolution peripheral quantitative computed tomography (HR-pQCT) examinations to determine bone mineral density and bone structure/quality.
The hypothesis of this pilot project is that type II diabetic patients with and without low-energy fractures have a different trabecular bone architecture and composition, which is also different when compared to normal age-matched healthy patients. Architectural differences in these three patient groups may be visualized with high resolution MRI and high-resolution peripheral quantitative computed tomography (HR-pQCT) and will be most pronounced at the calcaneus and the distal tibia. Analyzing structure parameters obtained from high resolution MRI and spectroscopy may improve our understanding of the pathophysiology of diabetic bone disease and the prediction of fracture risk in an elderly diabetic population.
- Conditions
- Osteoporosis
- Being tested
- magnetic Resonance Imaging, Computed Tomography, High resolution peripheral quantitative computed tomography
- Keywords
- osteoporosis, diabetes
- Medical subject headings
- Osteoporosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic Resonance ImagingDevice
MRI of the calcaneus, the distal tibia, the distal radius and also lower back.
Computed TomographyDevice
CT scan of the lower back and hip
High resolution peripheral quantitative computed tomographyDevice
HR-pQCT of the distal radius and distal tibia
| Study group | Role | What they receive |
|---|---|---|
| 1 | Healthy post-menopausal women Receives: Device: magnetic Resonance Imaging; Device: High resolution peripheral quantitative computed tomography | |
| 2 | Diabetic without fracture Receives: Device: magnetic Resonance Imaging; Device: Computed Tomography; Device: High resolution peripheral quantitative computed tomography | |
| 3 | Diabetic with fracture Receives: Device: magnetic Resonance Imaging; Device: Computed Tomography; Device: High resolution peripheral quantitative computed tomography |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startMay 2006
- Primary completionJul 2009
- Study completionJul 2009
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 California, San FranciscoThe 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703417
- Sponsor's protocol ID
- Diabetes
- Status last verified
- Jun 2011
- First submitted
- 19 Jun 2008
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Bone Structure Explain the Increased Fracture Risk in Type II Diabetes Patients? A Pilot Study
- ClinicalTrials.gov ID
- NCT00703417
- Acronym / sponsor ID
- Diabetes
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 23 Jun 2008 (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.
For this cross-sectional case control pilot study 30 women, 55-75 years old with type II diabetes will be recruited. Diabetes will be defined as self-report of diabetes previously diagnosed by a physician, use of hypoglycemic medications, or fasting glucose > 126 mg/dl (7.0mM) in accordance with the American Diabetes Association criteria. The diabetic patient population will be divided into 2 groups: patients with status post low energy fractures of the proximal humerus, the proximal femur, the ankle and the foot (n=10) versus diabetic patients with no fractures or low energy trauma fracture history (n=10). An additional group of 10 diabetic postmenopausal women will be recruited and will have magnetic resonance imaging (MRI) of the lower back only. Caucasian, Asian and Hispanic women will be combined since a previous study suggested that BMD is very similar in these 3 population and that ethnic differences are minimal. In addition a population of 10 age-matched, BMI-matched, race-matched healthy women, without osteoporotic fractures will be examined. In all of these volunteers a medical history will be obtained to ensure good health status and rule out chronic diseases that would have an impact on bone metabolism. Patients will undergo MRI, QCT and high-resolution peripheral quantitative computed tomography (HR-pQCT) examinations to determine bone mineral density and bone structure/quality.
The hypothesis of this pilot project is that type II diabetic patients with and without low-energy fractures have a different trabecular bone architecture and composition, which is also different when compared to normal age-matched healthy patients. Architectural differences in these three patient groups may be visualized with high resolution MRI and high-resolution peripheral quantitative computed tomography (HR-pQCT) and will be most pronounced at the calcaneus and the distal tibia. Analyzing structure parameters obtained from high resolution MRI and spectroscopy may improve our understanding of the pathophysiology of diabetic bone disease and the prediction of fracture risk in an elderly diabetic population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: magnetic Resonance Imaging, Device: High resolution peripheral quantitative computed tomographyHealthy post-menopausal women |
| 2 | – | Device: magnetic Resonance Imaging, Device: Computed Tomography, Device: High resolution peripheral quantitative computed tomographyDiabetic without fracture |
| 3 | – | Device: magnetic Resonance Imaging, Device: Computed Tomography, Device: High resolution peripheral quantitative computed tomographyDiabetic with fracture |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 10 healthy postmenopausal women 10 postmenopausal women with Type II Diabetes and without fracture 10 postmenopausal women with Type II Diabetes and with fracture of the long bone of the upper arm, hip, ankle, or foot 10 postmenopausal women with Type II Diabetes with and without fracture
Key inclusion criteria (6 listed)
- Postmenopausal female, 55-75 years old
- History of Type II diabetes, as defined by the American Diabetes Association for more than 5 years that is either insulin requiring or treated with oral therapies such as sulfonylureas and metformin
- Body mass index (BMI) of 19-35
- Able to move without walkers and without a history of long periods (>3 months) of inactivity
- Additional Inclusion criteria for fracture participants:
Key exclusion criteria (11 listed)
- Severe neuropathic disease such as neurogenic osteoarthropathies (i.e., Charcot joints) of the foot
- Steroid users or have disease conditions that could play a significant role in the development of osteoporosis such as idiopathic osteoporosis, immobilization, hyperparathyroidism, or hyperthyroidism
- Diseases that may affect bone metabolism: alcoholism, chronic drug use, chronic gastrointestinal disease, renal or hepatic impairment
- Chronic treatment with antacids, estrogen, adrenal or anabolic steroids, anticonvulsants, anticoagulants, or pharmacologic doses of Vitamin A supplements 6 months prior
- Diabetic patients on rosiglitazone or pioglitazone medications
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 |
|---|---|---|
| magnetic Resonance ImagingMRI of the calcaneus, the distal tibia, the distal radius and also lower back. | Device | 1, 2, 3 |
| Computed TomographyCT scan of the lower back and hip | Device | 2, 3 |
| High resolution peripheral quantitative computed tomographyHR-pQCT of the distal radius and distal tibia | Device | 1, 2, 3 |
Primary outcome
Not reported in the source record.
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 8 Jun 2011.
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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?
An observational study of Osteoporosis, run by University of California, San Francisco 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 6 inclusion and 11 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 8 Jun 2011. 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.
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 8 Jun 2011.