The Efficacy of Velcade on Bone Tissue During Myelomatosis (Bone Marrow Cancer)
The primary objective of the the study is to investigate the changes in bone remodeling during Velcade treatment.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Efficacy of Velcade on Bone Tissue During Myelomatosis (Bone Marrow Cancer)|
- Changes in bone markers during treatment
- Changes in osteolysis during treatment
|Study Start Date:||February 2007|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
20 patients will be included in the study over a 2 year period. Before, during and after treatment we will measure NTX-I, CTX-I, CTX-MMP, bALP, DKK-1, PINP, TRAcP and PTH. NTX, CTX and CTX-MMP are measured to estimate bone degradation. TRAcP is measured to estimate the activity of the osteoclasts. bALP and DKK-1 is measured to evaluate the activity of the osteoblasts and PINP is measured as a marker of new bone formation. PTH is measured in order to evaluate if the positive effects that is observed in bone formation in relations to velcade treatment is due to the pulsative way velcade is administered.
The effect of the velcade treatment will be evaluated by x-ray, bone marrow and m-component.
|University Hospital Odense|
|Odense, Denmark, 5000|
|Vejle, Denmark, 7100|
|Principal Investigator:||Torben Plesner, MD||Vejle Hospital|