Biomechanics of Metastatic Defects in Bone
Biomechanics of Metastatic Defects in Bone
The purpose of this study is to monitor fracture risk associated with bone tumors in cancer
 patients.

 Previous studies from our lab have suggested that it is possible to compute the mechanical
 strength of bones with tumors using computed tomography (CT) scans, which are like
 three-dimensional X-ray pictures of the affected bones.

 The next step in determining the usefulness of this type of strength analysis is to see if we
 can accurately predict who is at risk for bone fracture and which patients are at high risk
 of fractures.

 This non-invasive analysis may help physicians determine the best treatment to reduce the
 risk of an impending bone fracture in the future.
If a patient agrees to participate in this study, we will ask the patient to complete two
 written, self-administered questionnaires. The questionnaires will take about fifteen minutes
 to complete and contain questions about the patient's general health as well as questions
 specific to the site of the bone tumor. The patient will be asked to complete the first
 questionnaire upon enrollment in the study, and the second when participation in the study is
 concluded. The patient will be asked to complete and return the questionnaire to the project
 coordinator at this time. If for any reason the patient is unable to complete the
 questionnaire at this time, he/she will be asked to return it to the project coordinator
 within two weeks using a stamped, pre-addressed envelope, which will be provided.

 The treating physician has ordered both an X-ray picture and a three-dimensional CT scan
 image of the involved bone plus the contralateral limb (lower limbs). He/she will be provided
 with a standard report from the radiologist describing the appearance of the bone tumor and
 the bone itself which the treating physician will use to determine the course of treatment
 he/she deems appropriate. We will perform a special analysis of the CT images that will allow
 us to estimate the strength of the bone with the tumor. Based on this engineering analysis of
 the strength of the bone, the treating physician may alter the prescribed treatment to
 decrease the risk that bone will fracture. If the patient does not have a fracture within the
 follow-up period (four months), he/she will undergo a second CT scan to determine the
 response of the tumor to treatment and changes in the strength of the bone. If the patient
 does have a fracture within the follow-up period, he/she will undergo a second CT scan to
 determine the integrity of the remaining bone to help your physician plan the next course of
 action. We will use the second CT scan to estimate how weak the bone was just prior to
 fracture. In either case, the patient's participation in this study will be concluded after
 the second CT scan.

 Patient participation in the study will last four months. If the patient has a fracture
 before four months, his/her participation will end at that time.

 The investigator and/or the treating physician may decide to take the patient off this study
 if

 1. patient refuses or is unable to complete study procedures;

 2. patient develops weakness or numbness in his/her limbs due to your disease;

 3. patient's bone fractures due to significant trauma (e.g., traffic accident, fall from
 height);

 4. a different bone fractures, limiting patient's ability to put pressure on the bone of
 interest; or

 5. patient relocate.

 The patient can end his/her participation at any time. The patient's decision to withdraw
 from the study will not affect in any way his/her medical care and/or benefits. If the
 patient decides to end his/her participation in the study, we encourage him/her to discuss
 the decision the treating physician.

 STUDY LOCATION Privacy Patients will be approached by treating physicians at clinic and
 privately (in the examination room), where they can privately describe the study, answer any
 questions the patient might have and potentially enroll the patient in the study. Patient
 privacy and confidentiality will be strictly observed during all steps of recruitment,
 reporting of data and follow up conversations.

 Physical Setting

 All patient related activity will be conducted in the hospital as the patient undergoes
 treatment. CT data analysis will be performed at the Center for advanced Orthopaedic Studies
 at BIDMC.

 DATA SECURITY All data will be kept behind BIDMC firewall at an access controlled computer
 designated for this study only. Additionally, the patient data will be anonymized and a
 number will be assigned to protect the patient identity, therefore those conducting analysis
 on the CT data will have no access to patient identifiable information.
Inclusion Criteria:

 Patient with metastatic cancer bone lesions

 Exclusion Criteria:

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