FREE Study - Fracture Reduction Evaluation

Inclusion Criteria: * Minimum of one painful, acute (edema present on MRI obtained within a two weeks period prior to enrolment) thoracic or lumbar (T5-L5) vertebral body compression fracture, due to osteopenia arising from primary or secondary osteoporosis, multiple myeloma, or osteolytic metastatic tumors and maximum of three painful fractures requiring treatment. (NOTE: a T2-weighted MRI should be done unless it is not available); * Minimum of one acute fracture to be treated that has height loss \> 15% of predicted height (average height of two adjacent "normal" vertebrae) when measured at the middle of the vertebral endplate. (NOTE: If the adjacent vertebrae are not normal, the predicted height will be based on the height listed for the fractured vertebra in the table taken from Black et al.) * Pre-treatment VAS score \> 4 on a scale of 10 where 0 is no pain, 5 is moderate pain and 10 is pain "as bad as you can imagine"; * Patient 21 years of age or older; * The investigator and surgeon/radiologist agree before randomization that the fracture(s) can technically be reduced using an inflatable bone tamp (IBT); and * A signed Informed Consent is obtained from the patient. Exclusion Criteria: * Previous vertebroplasty; * Vertebral body fracture morphology prevents use of devices (such as endplate below pedicles); * Pedicle fractures; * Acute fracture(s) to be treated symptomatic \> 3 months at enrollment; * Pre-existing (not the result of the index fracture) neurological …