NCT01816022

Myeloproliferative Neoplasms and Bone Structure

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 125 (estimated)
• Sponsor: University of Southern Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polycythemia Vera
• Thrombocythemia, Essential
• Primary Myelofibrosis

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-03-01
• Completion: 2015-03-01
• First posted: 2013-03-21
• Last updated: 2013-03-21

Locations

1 site across 1 country: Denmark