Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT00294151
Eligibility Criteria:
Inclusion Criteria:
* Between 35 and 75 years old
* Biopsy-proven breast cancer (BC) or prostate cancer (PC)
* Radiographic evidence of spine metastases from the BC or PC in the lumbar and/or mid-low thoracic spine
* Microfractures or compression fractures up to 40% of the original height of the vertebral body in an MRI \[magnetic resonance imaging\] (reported by an independent radiologist)
* Incidental back pain (Verbal Analog Scale \> 5/10) felt to be related to those metastases
Exclusion Criteria:
* Spinal cord compression
* Massive rupture of the posterior wall of the vertebral body (according to blinded radiological report)
* Coagulopathy (International Normalized Ratio \[INR\] \> 1.5, platelets \< 80,000)
* Inability to communicate in English, French or Spanish
* Previous radiotherapy to the spine in the area presently affected
* Mental cognitive impairment
* Vertebral metastasis without fracture in the MRI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT00294151
Study Brief:
Protocol Section:
NCT00294151