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The Efficacy of Velcade on Bone Tissue During Myelomatosis (Bone Marrow Cancer)

Phase 2
Completed
Conditions
Multiple Myeloma
Registration Number
NCT00436059
Lead Sponsor
Vejle Hospital
Brief Summary

The primary objective of the the study is to investigate the changes in bone remodeling during Velcade treatment.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
Inclusion Criteria
  • Previously untreated multiple myeloma
Exclusion Criteria
  • Use of bisfosfonates

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Changes in bone markers during treatment
Secondary Outcome Measures
NameTimeMethod
Changes in osteolysis during treatment

Trial Locations

Locations (2)

University Hospital Odense

🇩🇰

Odense, Denmark

Vejle Hospital

🇩🇰

Vejle, Denmark

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