Assessment of Bone Micro-Architecture Using HR-pQCT

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94107
      • UCSF Imaging Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Community UCSF VA Medical Center

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
osteoporosis and osteopenia; Subjects will be stratified based on DXA BMD T-scores.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Sharmila Majumdar, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: June 2, 2011
• First Submitted That Met QC Criteria: June 6, 2011
• First Posted (Estimate): June 7, 2011

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: December 1, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: osteopenia and osteoporosis
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: Majumdar #39637