Assessment of Bone Micro-Architecture Using HR-pQCT

NCT01367730 | Completed

• 1 other identifier: Majumdar #39637
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

osteopenia and osteoporosis

Outcome Measures

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.

  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 Outcomes (2)

• Change in Compressive biomechanical bone properties from Baseline to 12 months

  12 months

• Association between BMD, bone micro-architecture, compressive biomechanical properties and body composition at all timepoints

  Baseline and 12 months

Study Arms (1)

osteoporosis and osteopenia

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

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community UCSF VA Medical Center

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

UCSF Imaging Center

San Francisco, California, 94107, United States

Location

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sharmila Majumdar, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 7, 2011
• Study Start: April 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

US (1)