Myeloproliferative Neoplasms and Bone Structure

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01816022

Enrollment

125

Registered

2013-03-21

Start date

2012-03-31

Completion date

2015-03-31

Last updated

2013-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycythemia Vera, Primary Myelofibrosis, Thrombocythemia, Essential

Keywords

CMPN, Fracture, Osteoporosis, Biochemical Bone Markers

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Denmark

Contacts

Primary ContactSarah Farmer, MD

mailtilsarah@yahoo.com+45 22324276

Backup ContactHanne Vestergaard, MD

Hanne.Vestergaard@ouh.regionsyddanmark.dk+45 26258550

Outcome results