Myeloproliferative Neoplasms and Bone Structure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Polycythemia Vera Thrombocythemia, Essential Primary Myelofibrosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No