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.
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
- Change in Compressive biomechanical bone properties from Baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Calculate the change in compressive biomechanical properties using µ-finite element analysis
- Association between BMD, bone micro-architecture, compressive biomechanical properties and body composition at all timepoints [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
Association between BMD, bone micro-architecture, compressive biomechanical properties and body composition at all timepoints using DXA, HR-pQCT, microfinite element analysis.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2014 (Final data collection date for primary outcome measure)
osteoporosis and osteopenia
Subjects will be stratified based on DXA BMD T-scores.
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.