Assessment of Bone Micro-Architecture Using HR-pQCT

Completed

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID

NCT01367730

Run by

University of California, San Francisco

People needed

80

Starts

2012-04-01

Expected to finish

2014-06-01

Last updated by the study team

2014-12-02

Who can join

Age: 50 and older, up to 85. Sex: male. Healthy volunteers: accepted.

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
• History of bilateral hip replacement, or bilateral wrist or ankle fracture

Where it is running

• UCSF Imaging Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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