Myeloproliferative Neoplasms and Bone Structure

• Conditions: Primary Myelofibrosis; Thrombocythemia, Essential; Polycythemia Vera

• Registration Number: NCT01816022
• Lead Sponsor: University of Southern Denmark

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.

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-09-18
• Status Verified: 2013-03
• Study First Submitted QC: 2013-03-20
• Last Update Submitted: 2013-03-20
• Study First Posted: 2013-03-21
• Last Update Posted: 2013-03-21
• Primary Completion: 2014-03
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density (BMD)	1 day	Patients will undergo one DXA scan independent of time of CMPN diagnosis

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Health Sciences, Institute of Clinical Research; 🇩🇰 Odense, Region Syddanmark, Denmark