Polycythemia VeraNCT01816022
Myeloproliferative Neoplasms and Bone Structure
An observational study of Polycythemia Vera and Thrombocythemia, Essential, run by University of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycythemia Vera, Thrombocythemia, Essential, Primary Myelofibrosis
- How many people
- 125 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Danish patients with CMPN
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Faculty of Health Sciences, Institute of Clinical Research
Odense, Region Syddanmark, 5000
Sarah Farmer, MD, +45 22324276, mailtilsarah@yahoo.com
Hanne Vestergaard, MD
About this study
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.
Read the 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.
- Keywords
- CMPN, Fracture, Osteoporosis, Biochemical Bone Markers
- Medical subject headings
- Polycythemia Vera, Thrombocythemia, Essential, Primary Myelofibrosis, Fractures, Bone, Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density (BMD)
Patients will undergo one DXA scan independent of time of CMPN diagnosis
Measured: 1 day
Secondary outcomes (1)
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startMar 2012
- Primary completionMar 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycythemia VeraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Farmer, University of Southern Denmark
- Investigators
- Sarah Farmer, MD, Principal investigator, Department of Hematology, Clinical Institute, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816022
- Sponsor's protocol ID
- HFEX 11.15
- Status last verified
- Mar 2013
- First submitted
- 18 Sep 2012
- Last updated
- 21 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25939704
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myeloproliferative Neoplasms and Bone Structure
- ClinicalTrials.gov ID
- NCT01816022
- Acronym / sponsor ID
- HFEX 11.15
- Keywords
- CMPN, Fracture, Osteoporosis, Biochemical Bone Markers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 21 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Danish patients with CMPN
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone Mineral Density (BMD)
Time frame: 1 day
Patients will undergo one DXA scan independent of time of CMPN diagnosis
1 secondary outcome
Evaluation of Geometry, Strength and Micro-Structure of the bone.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2013.
- Derived from this study: PubMed 25939704Farmer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Farmer, MD principal investigator
Department of Hematology, Clinical Institute, University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycythemia Vera and Thrombocythemia, Essential, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Farmer, MD (+45 22324276, mailtilsarah@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density (BMD) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01816022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2013.