Myeloproliferative Neoplasms and Bone Structure

University of Southern Denmark (SDU)

Status: Unknown

Conditions: Polycythemia Vera; Primary Myelofibrosis; Thrombocythemia, Essential

Study type: Observational

Funder types: Other

Identifiers

NCT01816022

HFEX 11.15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.