- Any serious medical or psychiatric condition that may interfere with participation or outcome assessment such as: need for uninterrupted anti-coagulation, spinal fracture, active infection or metastatic disease suspected, active cancer, poorly controlled diabetes, or patients with diabetes on any insulin, uncontrolled hypertension (systolic blood pressure >180 or diastolic blood pressure >110 within 30 days of randomization date), active peptic ulcer disease, history of intolerance to steroid therapy, previous or current psychiatric history of bipolar disease, or secondary gain such as anticipated or ongoing legal proceedings, history of substance abuse