Assessment of Bone Micro-Architecture Using HR-pQCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01367730
Recruitment Status : Completed
First Posted : June 7, 2011
Last Update Posted : December 2, 2014
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease

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
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Invasive Assessment of Bone Micro-architecture and Strength Changes in Men With Osteopenia and Osteoporosis
Study Start Date : April 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

osteoporosis and osteopenia
Subjects will be stratified based on DXA BMD T-scores.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Change in Compressive biomechanical bone properties from Baseline to 12 months [ Time Frame: 12 months ]
    Calculate the change in compressive biomechanical properties using µ-finite element analysis

  2. Association between BMD, bone micro-architecture, compressive biomechanical properties and body composition at all timepoints [ Time Frame: Baseline and 12 months ]
    Association between BMD, bone micro-architecture, compressive biomechanical properties and body composition at all timepoints using DXA, HR-pQCT, microfinite element analysis.

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community UCSF VA Medical Center

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01367730

United States, California
UCSF Imaging Center
San Francisco, California, United States, 94107
Sponsors and Collaborators
University of California, San Francisco
Merck Sharp & Dohme Corp.
Principal Investigator: Sharmila Majumdar, PhD University of California, San Francisco

Responsible Party: University of California, San Francisco Identifier: NCT01367730     History of Changes
Other Study ID Numbers: Majumdar #39637
First Posted: June 7, 2011    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014

Keywords provided by University of California, San Francisco:
osteopenia and osteoporosis

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases