Myeloproliferative Neoplasms and Bone Structure

NCT01816022 | Unknown

• 1 other identifier: HFEX 11.15
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycythemia Vera; Thrombocythemia, Essential; Primary Myelofibrosis

Keywords

CMPN; Fracture; Osteoporosis; Biochemical Bone Markers

Outcome Measures

Primary Outcomes (1)

• Bone Mineral Density (BMD)

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

  1 day

Secondary Outcomes (1)

• Evaluation of Geometry, Strength and Micro-Structure of the bone.

  1 day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Danish patients with CMPN

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Faculty of Health Sciences, Institute of Clinical Research

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 25939704 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples to compare groups and to look for endocrine abnormalities

MeSH Terms

Conditions

Polycythemia Vera; Thrombocythemia, Essential; Primary Myelofibrosis; Fractures, Bone; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders; Blood Coagulation Disorders; Thrombocytosis; Blood Platelet Disorders; Hemorrhagic Disorders; Wounds and Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sarah Farmer, MD

  Department of Hematology, Clinical Institute, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Farmer, MD

CONTACT

+45 22324276; mailtilsarah@yahoo.com

Hanne Vestergaard, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 18, 2012
• First Posted: March 21, 2013
• Study Start: March 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2015
• Last Updated: March 21, 2013

Record last verified: 2013-03

Locations

DK (1)