Assessment of Bone Micro-Architecture Using HR-pQCT

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367730
• Other study ID #: Majumdar #39637
• Status: Completed
• Phase: N/A
• First received: June 2, 2011
• Last updated: December 1, 2014
• Start date: April 2012
• Est. completion date: June 2014

Study information

• Verified date: December 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis

Locations

Country	Name	City	State
United States	UCSF Imaging Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No