Myeloproliferative Neoplasms and Bone Structure

Sponsor

University of Southern Denmark (Other)

Overall Status

Unknown status

CT.gov ID

NCT01816022

Collaborator

(none)

125

Enrollment

Location

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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 tomography).Biochemical bone markers is measured to support the hypothesis.

Condition or Disease	Intervention/Treatment	Phase
Polycythemia Vera Thrombocythemia, Essential Primary Myelofibrosis

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 phosphatase)and P1NP.

The outcome is compared to healthy control individuals.

Study Design

Study Type:

Observational

Anticipated Enrollment :

125 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Myeloproliferative Neoplasms and Bone Structure

Study Start Date :

Mar 1, 2012

Anticipated Primary Completion Date :

Mar 1, 2014

Anticipated Study Completion Date :

Mar 1, 2015

Outcome Measures

Primary Outcome Measures

Bone Mineral Density (BMD) [1 day]
Patients will undergo one DXA scan independent of time of CMPN diagnosis

Secondary Outcome Measures

Evaluation of Geometry, Strength and Micro-Structure of the bone. [1 day]
Patients will undergo one HR.pQCT indepedent of the time of the diagnosis of CMPN

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of PV (according to WHO 2008 criteria), only JAK2-pos.(Janus kinase 2)
Diagnosis of ET (according to WHO 2008 criteria), only JAK2-pos.
Diagnosis of PMF (according to WHO 2008 criteria)independent of JAK2-status.

Exclusion Criteria:

Pregnancy
Bone Diseases (Mb. Pagets, Myelomatosis, MGUS (monoclonal gammopathy of undetermined significance), osteogenesis imperfecta, Prim. hyperparathyroidism, osteomalacia.
Drugs (Prednisone>3 mth, anti-osteoporotic drugs, anti-estrogen drugs.
Presence of any psychologic condition or language barrier, which may interfere which a complete understanding, and arise ethnical considerations.