Clinical trial NCT01816022: Myeloproliferative Neoplasms and Bone Structure
Official title: Myeloproliferative Neoplasms and Bone Structure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polycythemia Vera
Thrombocythemia, Essential
Primary Myelofibrosis
Keywords: CMPN
Fracture
Osteoporosis
Biochemical Bone Markers
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2013-03-21
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Danish patients with CMPN

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bone Mineral Density (BMD)
timeFrame: 1 day
Secondary outcomes:
measure: Evaluation of Geometry, Strength and Micro-Structure of the bone.
timeFrame: 1 day
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Faculty of Health Sciences, Institute of Clinical Research
state: Region Syddanmark
Study officials:
affiliation: Department of Hematology, Clinical Institute, University of Southern Denmark
name: Sarah Farmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farmer S, Vestergaard H, Hansen S, Shanbhogue VV, Stahlberg CI, Hermann AP, Frederiksen H. Bone geometry, bone mineral density, and micro-architecture in patients with myelofibrosis: a cross-sectional study using DXA, HR-pQCT, and bone turnover markers. Int J Hematol. 2015 Jul;102(1):67-75. doi: 10.1007/s12185-015-1803-3. Epub 2015 May 5.