OsteoporosisNCT01367730
Assessment of Bone Micro-Architecture Using HR-pQCT
An observational study of Osteoporosis, run by University of California, San Francisco at 1 site in United States.
Trial summary
In the context of male osteoporosis, we hypothesize that regional changes in trabecular bone, as well as changes in cortical porosity will play a major role, and thus also affect bone strength. Read more about this study
- Who is it for?
- Ages 50 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jun 2014
- 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 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community UCSF VA Medical Center
Who may be able to join
- Men 50-85 years old
- Patients must be willing to undergo a DXA scan.
- Patients should be willing to undergo HRpQCT scan of the radius and tibia.
Who cannot join
- Inability to tolerate CT scans
- Use of medications known to impact bone and mineral metabolism:
- use of a bisphosphonate or teriparatide in the last year or for >12 months ever;
- current calcitonin;
- prednisone >5 mg daily or the equivalent glucocorticoid for >10 days in the last 3 months;
- current testosterone therapy;
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- current thiazolidinedione (TZD);
- current androgen deprivation therapy;
- current use of an antiepileptic agent that alters hepatic vitamin D clearance;
- use of thyroid hormone replacement with current thyroid stimulating hormone <0.1 mIU/L
- Disease known to affect bone (e.g., primary hyperparathyroidism, Pagets disease, clinically significant liver disease)
- Illicit drug use or alcohol use >3 drinks/day
- Serum calcium >10.2 mg/dL or calculated creatinine clearance <30 mL/min
- Weight >350 pounds (the maximum weight limit of the DXA)
- Hardware in the lumbar spine
- History of bilateral hip replacement, or bilateral wrist or ankle fracture
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Imaging Center
San Francisco, California, 94107
About this study
Official title: Non-Invasive Assessment of Bone Micro-architecture and Strength Changes in Men With Osteopenia and Osteoporosis
In the context of male osteoporosis, we hypothesize that regional changes in trabecular bone, as well as changes in cortical porosity will play a major role, and thus also affect bone strength. In developing therapeutics the response of individual compartments, regional variations post-therapy will have considerable impact on selecting the therapies as well as monitoring response to therapy. This study, a precursor to other therapeutic trials, will lay the ground-work for the future.
Read the detailed description
We will recruit 80 subjects who will be stratified into groups based on their T-scores. All subjects will be imaged at Baseline and 12 months. Measures of bone micro-architecture in the tibia and radius using peripheral computed tomography, bone strength measures through finite element analysis will be obtained at all time points. DXA measures at the spine, femur and forearm will be obtained as reference measures. In addition whole body DXA scans will be performed for assessment of body composition.
- Conditions
- Osteoporosis
- Keywords
- osteopenia and osteoporosis
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
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 |
|---|---|---|
| osteoporosis and osteopenia | Subjects will be stratified based on DXA BMD T-scores. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure cross-sectional and longitudinal differences in bone micro-architecture and strength changes in men with BMD T-scores ≤-2.0 and those with T-scores >-1.0.
Trabecular bone micro-architecture as measured by trabecular number, trabecular BMD, and trabecular bone volume fraction (BV/TV). Cortical bone micro-architecture will be assessed by measuring cortical density \& thickness and porosity.
Measured: 12 months
Secondary outcomes (2)
Change in Compressive biomechanical bone properties from Baseline to 12 months
Calculate the change in compressive biomechanical properties using µ-finite element analysis
Measured: 12 months
Association between BMD, bone micro-architecture, compressive biomechanical properties and body composition at all timepoints
Association between BMD, bone micro-architecture, compressive biomechanical properties and body composition at all timepoints using DXA, HR-pQCT, microfinite element analysis.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startApr 2012
- Primary completionJun 2014
- Study completionJun 2014
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Sharmila Majumdar, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367730
- Sponsor's protocol ID
- Majumdar #39637
- Status last verified
- Dec 2014
- First submitted
- 2 Jun 2011
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Assessment of Bone Micro-architecture and Strength Changes in Men With Osteopenia and Osteoporosis
- ClinicalTrials.gov ID
- NCT01367730
- Acronym / sponsor ID
- Majumdar #39637
- Conditions
- Osteoporosis
- Keywords
- osteopenia and osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Apr 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Jun 2011 (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.
In the context of male osteoporosis, we hypothesize that regional changes in trabecular bone, as well as changes in cortical porosity will play a major role, and thus also affect bone strength. In developing therapeutics the response of individual compartments, regional variations post-therapy will have considerable impact on selecting the therapies as well as monitoring response to therapy. This study, a precursor to other therapeutic trials, will lay the ground-work for the future.
Detailed description
We will recruit 80 subjects who will be stratified into groups based on their T-scores. All subjects will be imaged at Baseline and 12 months. Measures of bone micro-architecture in the tibia and radius using peripheral computed tomography, bone strength measures through finite element analysis will be obtained at all time points. DXA measures at the spine, femur and forearm will be obtained as reference measures. In addition whole body DXA scans will be performed for assessment of body composition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| osteoporosis and osteopenia | – | –Subjects will be stratified based on DXA BMD T-scores. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community UCSF VA Medical Center
Key inclusion criteria (3 listed)
- Men 50-85 years old
- Patients must be willing to undergo a DXA scan.
- Patients should be willing to undergo HRpQCT scan of the radius and tibia.
Key exclusion criteria (16 listed)
- Inability to tolerate CT scans
- Use of medications known to impact bone and mineral metabolism:
- Disease known to affect bone (e.g., primary hyperparathyroidism, Pagets disease, clinically significant liver disease)
- Illicit drug use or alcohol use >3 drinks/day
- Serum calcium >10.2 mg/dL or calculated creatinine clearance <30 mL/min
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
Measure cross-sectional and longitudinal differences in bone micro-architecture and strength changes in men with BMD T-scores ≤-2.0 and those with T-scores >-1.0.
Time frame: 12 months
Trabecular bone micro-architecture as measured by trabecular number, trabecular BMD, and trabecular bone volume fraction (BV/TV). Cortical bone micro-architecture will be assessed by measuring cortical density \& thickness and porosity.
2 secondary outcomes
Change in Compressive biomechanical bone properties from Baseline to 12 months
Time frame: 12 months
Association between BMD, bone micro-architecture, compressive biomechanical properties and body composition at all timepoints
Time frame: Baseline and 12 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 2 Dec 2014.
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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.
Sharmila Majumdar, PhD principal investigator
University of California, San Francisco
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 3 inclusion and 16 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 2 Dec 2014. 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?
Measure cross-sectional and longitudinal differences in bone micro-architecture and strength changes in men with BMD T-scores ≤-2.0 and those with T-scores >-1.0. (time frame: 12 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 2 Dec 2014; AzTrials last refreshed its copy on 2 Nov 2026.