Clinical trial: A Safety and Efficacy Study for Treatment of Painful Vertebral Compression Fractures Caused by Osteoporosis (NCT00290862)

Eligibility criteria:
Inclusion Criteria:

          -  Are at least 18 years of age

          -  Have sustained a painful osteoporotic vertebral compression fracture (VCF) for at
             least 4 weeks but no longer than 1 year or have radiographic evidence of at least 5%
             worsening vertebral collapse as compared to previous radiographic evidence

          -  Give written Informed Consent to participate in the study and be willing to comply
             with protocol requirements

          -  Have pain requiring the regular use of analgesics or have a substantially altered
             life-style due to pain or disability

          -  Have central pain over the spinous process upon palpation at the planned level(s)

          -  Are appropriately communicative to verbalize and differentiate with regard to location
             and intensity of their pain

          -  Are physically and mentally willing and able to comply with the clinical and
             radiographic follow-up schedule

          -  Have radiographic evidence of one or two, Grade 1 or greater according to Genant's
             criteria, osteoporotic VCF(s) between (and including) the level of the sixth (6th)
             thoracic to the fifth (5th) lumbar

          -  Have an acute or persistent (not healed) fracture demonstrated by magnetic resonance
             imaging (MRI) or bone scan

          -  Have a patient self-assessment VAS score >= 50 mm at the pre-treatment visit

          -  Have a 30% or greater disability score on the baseline ODI (version 2.0).

        Exclusion Criteria:

          -  Have significant vertebral collapse defined as more than 70% of original vertebral
             height, or a burst or pedicle fracture with posterior cortical wall disruption

          -  Have posterior vertebral wall displacement occupying more than 20% of the cross
             sectional area of the spinal canal

          -  Have neurologic symptoms or deficits, or radiculopathy related to the VCF

          -  Have pain based on a clinical diagnosis of herniated nucleus pulposus, high energy
             trauma, severe spinal stenosis as evidenced by progressive weakness or paralysis, or
             bone tumor at the level(s) of pathology as evidenced by computed tomography (CT) scan

          -  Have indications of instability related to the VCF at the level to be treated (e.g.,
             neurologic deficit, kyphosis > 30º, translation > 4 mm, and/or interspinous process
             widening)

          -  Have canal compromise causing clinical manifestations of cord, neural foramen, or
             nerve root compression at the level(s) to be treated

          -  Have a bleeding disorder, including coagulopathy

          -  Have severe cardiopulmonary deficiencies

          -  Have an active systemic or local infection

          -  Are currently being treated for cancer or HIV

          -  Have a known allergy to acrylics (e.g., methyl methacrylate)

          -  Subject is currently an alcohol, solvent or drug abuser

          -  Female patients who are pregnant or nursing, or of childbearing potential not using a
             reliable contraceptive method

          -  Are involved in medical litigation

          -  Are prisoners

          -  Have participated in another investigational study within 30 days prior to inclusion
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? Entailment