Assessment of Bone Micro-Architecture Using HR-pQCT

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01367730
First received: June 2, 2011
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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
Osteoporosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Invasive Assessment of Bone Micro-architecture and Strength Changes in Men With Osteopenia and Osteoporosis

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

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: 80
Study Start Date: April 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
osteoporosis and osteopenia
Subjects will be stratified based on DXA BMD T-scores.

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

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community UCSF VA Medical Center

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367730

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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01367730     History of Changes
Other Study ID Numbers: Majumdar #39637
Study First Received: June 2, 2011
Last Updated: June 26, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 20, 2014