Ignite Creation Date:
2024-05-06 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01816022
Status:
UNKNOWN
Last Update Posted:
2013-03-21
First Post:
2012-09-18
Brief Title:
Myeloproliferative Neoplasms and Bone Structure
Sponsor:
University of Southern Denmark
Organization:
University of Southern Denmark
Study Overview
Official Title:
Myeloproliferative Neoplasms and Bone Structure
Status:
UNKNOWN
Status Verified Date:
2013-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a clinical study to evaluate the effect of CMPN Chronic myeloproliferative neoplasm to the bone
The hypothesis is that patients with CMPN have a higher fracture-rate compared to the background population We expect to find a lower BMD using conventional DXA scan dual energy x-ray absorptiometry and a change in other parameters using HR-pQCT high-resolution peripheral quantitative computerized tomographyBiochemical bone markers is measured to support the hypothesis
The hypothesis is that patients with CMPN have a higher fracture-rate compared to the background population We expect to find a lower BMD using conventional DXA scan dual energy x-ray absorptiometry and a change in other parameters using HR-pQCT high-resolution peripheral quantitative computerized tomographyBiochemical bone markers is measured to support the hypothesis
Detailed Description:
This is a clinical study to evaluate the effect of CMPN to the bone
Three individual cohorts are defined a cohort consisting of 50 patients with Polycythemia Vera PV a cohort consisting of 50 patients with Essential Thrombocythemia ET and a cohort consisting of 25 patients with Primary Myelofibrosis PMF
Patients are recruited from the Department of Hematology Odense University Hospital
Interventions consist of
Conventional DXA scan to measure Bone Mineral Density BMD
Experimental HR-pQCT to assess geometry strength and microstructure of the bone in 3 dimension
Blood-samples are collected and frozen for later analyses of Biochemical Bone Markers 1-CTP Ctx ALP alkaline phosphataseand P1NP
The outcome is compared to healthy control individuals
Three individual cohorts are defined a cohort consisting of 50 patients with Polycythemia Vera PV a cohort consisting of 50 patients with Essential Thrombocythemia ET and a cohort consisting of 25 patients with Primary Myelofibrosis PMF
Patients are recruited from the Department of Hematology Odense University Hospital
Interventions consist of
Conventional DXA scan to measure Bone Mineral Density BMD
Experimental HR-pQCT to assess geometry strength and microstructure of the bone in 3 dimension
Blood-samples are collected and frozen for later analyses of Biochemical Bone Markers 1-CTP Ctx ALP alkaline phosphataseand P1NP
The outcome is compared to healthy control individuals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None