Myeloproliferative Neoplasms and Bone Structure

March 20, 2013 updated by: Sarah Farmer, University of Southern Denmark

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Syddanmark
      • Odense, Region Syddanmark, Denmark, 5000
        • Recruiting
        • Faculty of Health Sciences, Institute of Clinical Research
        • Contact:
        • Contact:
          • Hanne Vestergaard, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Danish patients with CMPN

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Mineral Density (BMD)
Time Frame: 1 day
Patients will undergo one DXA scan independent of time of CMPN diagnosis
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Geometry, Strength and Micro-Structure of the bone.
Time Frame: 1 day
Patients will undergo one HR.pQCT indepedent of the time of the diagnosis of CMPN
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Investigators

  • Principal Investigator: Sarah Farmer, MD, Department of Hematology, Clinical Institute, University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

September 18, 2012

First Submitted That Met QC Criteria

March 20, 2013

First Posted (Estimate)

March 21, 2013

Study Record Updates

Last Update Posted (Estimate)

March 21, 2013

Last Update Submitted That Met QC Criteria

March 20, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFEX 11.15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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