Health-Related Quality of Life (QOL), Physical and Respiratory Function in Patients With Myeloma Affecting the Spine
NCT ID: NCT01006070
Last Updated: 2012-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2010-02-28
2011-03-31
Brief Summary
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Detailed Description
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The MMDB will be expanded to include parameters to identify those patients with myeloma affecting the spine. A recruitment letter will be sent to all patients in the MMDB identified as having myeloma affecting the spine asking if they would be interested in participating in this study.
Patients who agree to participate in the study will be given an appointment to meet with Dr. Wolf or Dr. Martin to discuss the study and if willing, to sign the informed consent document. They will have an exam and history taken that includes fracture history.
Patients who have signed consent will be sent for thoracic-lumbar spine films (unless they had prior spine films taken within the last 3 months). Those with normal films will not be eligible to be enrolled to the study. Those with abnormal spinal films will then be sent for MRI of the spine, pulmonary function testing, and meeting with Dr. R. Yonge who will administer the various QOL tests described below.
All eligible established and new patients will be invited to participate in the prospective study. Patients who sign the informed consent will be included in the prospective study. A minimum of 25 patients with vertebral fractures and 25 patients without fractures, will be observed to measure the impact of fractures on health-related quality of life. Study enrollment will be complete when 25 patients without a new fracture and 25 patients with a new fracture treated by balloon kyphoplasty have been enrolled.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients with existing spinal fractures
Myeloma patients with documented x-ray evidence of spinal fractures.
kyphoplasty
surgical kyphoplasty
Patients without spinal fractures
Myeloma patients with bony disease in the spine without existing fractures.
kyphoplasty
surgical kyphoplasty
Interventions
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kyphoplasty
surgical kyphoplasty
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Medtronics, Inc.
INDUSTRY
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Wolf, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Sigurd Berven, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Thomas Martin, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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UCSF
San Francisco, California, United States
Countries
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Other Identifiers
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0901Wolf
Identifier Type: -
Identifier Source: org_study_id
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