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Completed

NCT Number: NCT01367730

Assessment of Bone Micro-Architecture Using HR-pQCT

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.

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Key information

Age range

50 year–85 year

Sex eligibility

Male

Study type

Observational

Primary location

UCSF Imaging Center

San Francisco, California, 94107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Non-Invasive Assessment of Bone Micro-architecture and Strength Changes in Men With Osteopenia and Osteoporosis

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 7, 2011
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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