Suspended

Myeloproliferative Neoplasms and Bone Structure

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What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Blood Coagulation Disorders+20

+ Blood Platelet Disorders

+ Bone Diseases

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: March 2012
See protocol details

Summary

Principal SponsorUniversity of Southern Denmark
Study ContactSarah Farmer, MDMore contacts
Last updated: March 21, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01816022
Principal SponsorUniversity of Southern Denmark
Study ContactSarah Farmer, MDMore contacts
Last updated: March 21, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

125 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Coagulation DisordersBlood Platelet DisordersBone DiseasesBone Diseases, MetabolicBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersMetabolic DiseasesMusculoskeletal DiseasesMyeloproliferative DisordersNeoplasmsNeoplasms by SiteNutritional and Metabolic DiseasesThrombocytosisWounds and InjuriesBone Marrow NeoplasmsHematologic NeoplasmsOsteoporosisPolycythemia VeraThrombocythemia, EssentialFractures, BonePrimary Myelofibrosis

Criteria

3 inclusion criteria required to participate
Diagnosis of ET (according to WHO 2008 criteria), only JAK2-pos
Diagnosis of PMF (according to WHO 2008 criteria)independent of JAK2-status
Diagnosis of PV (according to WHO 2008 criteria), only JAK2-pos.(Janus kinase 2)
4 exclusion criteria prevent from participating
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
Pregnancy
Presence of any psychologic condition or language barrier, which may interfere which a complete understanding, and arise ethnical considerations

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Faculty of Health Sciences, Institute of Clinical Research

Odense, DenmarkOpen Faculty of Health Sciences, Institute of Clinical Research in Google Maps
SuspendedOne Study Center