Know Cancer

or
forgot password

Myeloproliferative Neoplasms and Bone Structure


N/A
18 Years
N/A
Open (Enrolling)
Both
Polycythemia Vera, Thrombocythemia, Essential, Primary Myelofibrosis

Thank you

Trial Information

Myeloproliferative Neoplasms and Bone Structure


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Bone Mineral Density (BMD)

Outcome Description:

Patients will undergo one DXA scan independent of time of CMPN diagnosis

Outcome Time Frame:

1 day

Safety Issue:

No

Principal Investigator

Sarah Farmer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Hematology, Clinical Institute, University of Southern Denmark

Authority:

Denmark: The Danish National Committee on Biomedical Research Ethics

Study ID:

HFEX 11.15

NCT ID:

NCT01816022

Start Date:

March 2012

Completion Date:

March 2015

Related Keywords:

  • Polycythemia Vera
  • Thrombocythemia, Essential
  • Primary Myelofibrosis
  • CMPN
  • Fracture
  • Osteoporosis
  • Biochemical Bone Markers
  • Primary Myelofibrosis
  • Neoplasms
  • Myeloproliferative Disorders
  • Polycythemia
  • Polycythemia Vera
  • Thrombocythemia, Essential
  • Thrombocytosis

Name

Location