Please select the eligibility criteria that correspond to the clinical trial below.
Title: Investigational Vertebroplasty Efficacy and Safety Trial (INVEST)
Brief Summary: Vertebroplasty is a procedure used to stabilize broken vertebrae, the bones that form the spine. This study will evaluate the effectiveness of vertebroplasty for the treatment of fractures due to osteoporosis.


Options:
A: Inclusion Criteria:

* Painful (pain intensity of at least 4 on a scale from 0 to 10) osteoporotic vertebral fracture between levels T4 and L5
* Fragility; i.e. fracture not in relation with significant trauma
* Recent fracture, pain beginning not earlier than 1 year before inclusion

Exclusion Criteria:

* No vertebral edema on STIR MR images
* Uncorrectable bleeding diatheses
* Active infection
* Substantial retropulsion of bony fragments
* Non-osteoporotic fracture
* Concomitant neoplasm
B: Inclusion Criteria:

* Confirmed osteoporosis or osteopenia by a referring physician and/or medical history and physical exam OR osteopenia on plain film
* Vertebral compression fracture in vertebrae T4 through L5, of less than 1 year old
* Pain not responsive to standard medical therapy
* Current rating for pain intensity of at least 3 on a scale of 0 to 10

Exclusion Criteria:

* Evidence or suspicion of malignant tumor or spinal canal compromise
* Concomitant hip fracture
* Local or systemic infection
* Uncorrectable bleeding diatheses
* Surgery within the previous 60 days
* Lack of access to telephone
* Inability to communicate in English
* Dementia
* Pregnancy
* Abnormal renal function or anticipated venography
* Conscious sedation is contraindicated for subject
C: Inclusion Criteria/Exclusion Criteria:

* Patient is greater than 60 years of age.
* Patient has pain which is not adequately controlled by oral analgesia or which has required hospitalisation and prevents early mobilisation
* Patient has pain from one or two compression fractures of the vertebrae in the areas T4 to L5 confirmed with a sagittal STIR (short tau inversion recovery) and sagittal T1 weighted MRI scan of the spine. Patients with three or more recent fractures are excluded.
* Clinical history verifies that patient's fracture occurred in the previous 6 weeks.
* Patient does not have a known coagulopathy. If on warfarin, the INR should be less than 2.5 within the last three days.
* Patient has no contraindications for conscious sedation.
* Patient reports pain during ambulation or movement from the compression fracture(s) of at least seven (7) out of ten (10) on a numerical pain scale.
* Patient has access to a telephone.
* Patient speaks English well enough to answer all health questions via telephone.
* Patient has a confirmed diagnosis of osteoporosis via a BMD within 6 months of baseline or a QCT at baseline.
* Patient does not have a history of debilitating chronic back pain which requires regular analgesia.
* Patients with chronic back pain who regularly use medication containing any narcotic for a period greater than 6 weeks, that is prior to the acute fracture.
* Patient does not have significant retropulsed fragment or spinal canal compromise of greater than 20% by retropulsed fragment.
* Patient has no mental incapacity or dementia that makes him/her unable to give informed consent.
* Patient has no history of vertebral osteomyelitis.
* Patient has vertebral body collapse not greater than 60% relative to closest intact vertebra.
* Patient has no pedicle fractures.
* Patient has no active local or systemic infection.
* Patient has not had surgery (within the last 60 days).
* Patient has no concomitant hip fracture.
* Patient has no malignant tumour deposit (multiple myeloma), tumour mass, or tumour extension into the epidural space at the level of the fracture to be treated on MRI.
* Patient does not have severely immunocompromised health status (including any patient who is HIV positive, currently on chemotherapy, taking high doses of long term corticosteroids - defined as a dose of prednisone exceeding 10mg for greater than 3 months in the last 12 months, has a hematologic malignancy, or a transplant recipient.)
* Patient able to attend face to face visits.
D: * \> or = 50 years of age
* Compression fracture (T4-L5)within previous 12 mo.
* Pain from compression fracture
* No malignant tumor
* No back surgery

Answer: B