Myeloproliferative Neoplasms and Bone Structure | NCT01816022

Studies
Myeloproliferative Neoplasms and Bone Structure

NCT01816022

Sponsor

University of Southern Denmark

Status

Unknown status

Last Update Posted

Mar 21, 2013Estimated

Enrollment

125Estimated

Phase

Not provided

Conditions

Polycythemia Vera
Thrombocythemia, Essential
Primary Myelofibrosis

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Mar 2014Estimated

Completion Date

Mar 2015Estimated

First Submitted Date

Sep 18, 2012

First Submission Date that Met QC Criteria

Mar 20, 2013

First Posted Date

Mar 21, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2013

Last Update Posted Date

Mar 21, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

125Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bone Mineral Density (BMD)	Patients will undergo one DXA scan independent of time of CMPN diagnosis	1 day

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of Geometry, Strength and Micro-Structure of the bone.	Patients will undergo one HR.pQCT indepedent of the time of the diagnosis of CMPN	1 day

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Danish patients with CMPN

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sarah Farmer, MD	Contact	+45 22324276		mailtilsarah@yahoo.com
Hanne Vestergaard, MD	Contact	+45 26258550		Hanne.Vestergaard@ouh.regionsyddanmark.dk

Overall Officials

Name	Affiliation	Role
Sarah Farmer, MD	Department of Hematology, Clinical Institute, University of Southern Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Health Sciences, Institute of Clinical Research	Recruiting	Odense	Region Syddanmark	5000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25939704	Derived	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.

ID	Term
D011087	Polycythemia Vera
D013920	Thrombocythemia, Essential
D055728	Primary Myelofibrosis
D050723	Fractures, Bone
D010024	Osteoporosis

ID	Term
D019046	Bone Marrow Neoplasms
D019337	Hematologic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms