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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| osteoporosis and osteopenia | Subjects will be stratified based on DXA BMD T-scores. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Compressive biomechanical bone properties from Baseline to 12 months | Calculate the change in compressive biomechanical properties using µ-finite element analysis | 12 months |
| Association between BMD, bone micro-architecture, compressive biomechanical properties and body composition at all timepoints |
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Inclusion Criteria:
Exclusion Criteria:
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
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
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Community UCSF VA Medical Center
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| Name | Affiliation | Role |
|---|---|---|
| Sharmila Majumdar, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Imaging Center | San Francisco | California | 94107 | United States |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Association between BMD, bone micro-architecture, compressive biomechanical properties and body composition at all timepoints using DXA, HR-pQCT, microfinite element analysis. |
| Baseline and 12 months |