Clinical trial NCT01367730: Assessment of Bone Micro-Architecture Using HR-pQCT
Official title: Non-Invasive Assessment of Bone Micro-architecture and Strength Changes in Men With Osteopenia and Osteoporosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Keywords: osteopenia and osteoporosis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-06-07
Enrollment: 80
Sex: MALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community UCSF VA Medical Center

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Men 50-85 years old
2. Patients must be willing to undergo a DXA scan.
3. Patients should be willing to undergo HRpQCT scan of the radius and tibia.

Exclusion Criteria:

1. Inability to tolerate CT scans
2. 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;
   * 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
3. Disease known to affect bone (e.g., primary hyperparathyroidism, Pagets disease, clinically significant liver disease)
4. Illicit drug use or alcohol use \>3 drinks/day
5. Serum calcium \>10.2 mg/dL or calculated creatinine clearance \<30 mL/min
6. Weight \>350 pounds (the maximum weight limit of the DXA)
7. Hardware in the lumbar spine
8. History of bilateral hip replacement, or bilateral wrist or ankle fracture

Primary outcomes:
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.
timeFrame: 12 months
Secondary outcomes:
measure: Change in Compressive biomechanical bone properties from Baseline to 12 months
timeFrame: 12 months
measure: Association between BMD, bone micro-architecture, compressive biomechanical properties and body composition at all timepoints
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Imaging Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sharmila Majumdar, PhD
role: PRINCIPAL_INVESTIGATOR
References: