Myeloproliferative Neoplasms and Bone Structure

Primary Myelofibrosis Clinical Trial

Official title:

Myeloproliferative Neoplasms and Bone Structure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01816022
• Other study ID #: HFEX 11.15
• Status: Recruiting
• Phase: N/A
• First received: September 18, 2012
• Last updated: March 20, 2013
• Start date: March 2012
• Est. completion date: March 2015

Study information

• Verified date: March 2013
• Source: University of Southern Denmark
• Contact: Sarah Farmer, MD
• Phone: +45 22324276
• Email: mailtilsarah[@]yahoo.com
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: March 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myeloproliferative Disorders
• Polycythemia
• Polycythemia Vera
• Primary Myelofibrosis
• Thrombocythemia, Essential
• Thrombocytosis

Locations

Country	Name	City	State
Denmark	Faculty of Health Sciences, Institute of Clinical Research	Odense	Region Syddanmark

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density (BMD)	Patients will undergo one DXA scan independent of time of CMPN diagnosis	1 day	No
Secondary	Evaluation of Geometry, Strength and Micro-Structure of the bone.	Patients will undergo one HR.pQCT indepedent of the time of the diagnosis of CMPN	1 day	No