OsteoporosisNCT04524481
Osteoporosis and Haemophilia
An observational study of Osteoporosis and Haemophilia, run by PD Dr. Andreas Strauß at 1 site in Germany.
Trial summary
The aim of this study is to evaluate the prevalence of osteoporosis in adult patients with haemophilia. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Osteoporosis, Haemophilia, Bone Mass
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 19 Aug 2020to 1 Mar 2023
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥ 18 years of age) suffering from mild (FVIII or IX >5 %), moderate (FVIII or IX 1-5 %) or severe (FVIII or IX <1 %) haemophilia A or B
Who may be able to join
- Adult patients (≥ 18 years of age) suffering from mild (FVIII or IX >5 %), moderate (FVIII or IX 1-5 %) or severe (FVIII or IX <1 %) haemophilia A or B
- Submitted written consent to participate in the study
Who cannot join
- Patients suffering from other bleeding diseases
- PWH without written consent
- PWH < 18 years of age
- Secondary osteoporosis
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Bonn
Bonn, Northrhine Westfalia, 53127
Andreas Strauß, PD Dr.
Andreas Strauß, PD Dr.
About this study
Official title: Osteoporosis Screening in Adult Patients With Haemophilia and Influence of Physical Activity on the Prevalence of Osteoporosis
The aim of this study is to evaluate the prevalence of osteoporosis in adult patients with haemophilia.
Read the detailed description
The aim of this study is to evaluate the prevalence of osteoporosis in adult patients with haemophilia. Subsequently, the ascertained prevalence of osteoporosis in patients with haemophilia will be compared to the latest published data of osteoporosis in Germany. Furthermore, the impact of severity of haemophilia, comorbidities as well as the role of both physical activity and individual joint condition as influencing factors on the presence of osteoporosis will be analysed by this study.
- Conditions
- Osteoporosis, Haemophilia, Bone Mass
- Medical subject headings
- Osteoporosis, Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with mild haemophilia A or B | (FVIII or IX >5 %, ≥ 18 years' old) | |
| Patients with moderate haemophilia A or B | (FVIII or IX 1-5 %, ≥ 18 years' old) | |
| Patients with severe haemophilia A or B | (FVIII or IX <1 %, ≥ 18 years' old) |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mass/bone density maesurement
All patients with haemophilia of this study will receive a standardised bone density measurement by using the same dual energy X-ray absorptiometry (DXA) device.
Measured: 15 minutes
blood sample (Vit. D/Calcium)
The blood samples of all patients with haemophilia will be tested according to the guidelines of the confederation of osteology (DVO). These blood samples are necessary to assess the osteoporosis by measuring the Vitamin-D and Calcium level.
Measured: 10 minutes
Secondary outcomes (5)
haemophilia related clinical data
All patients with haemophilia record their individual substitution regime and bleeding events in individual patients' diaries. The patients are used to record and submit all necessary information about bleeding events, factor replacement regime. By doing so, the individual treatment regime per week as well as the annual (joint) bleeding rate will be assessed one year retrospectively.
Measured: 10 minutes
level of physical activity
In order to assess the individual level of physical activity, an individual movement profile will be created. For this purpose, the activity of each patient with haemophilia will be recorded by an electronic activity tracker. In addition, the grade of individual physical activity will be assessed on the basis of questionnaires.
Measured: non determinable
orthopaedic joint status
The clinical joint status will be examined in all patients with haemophilia by the World Federation Joint Examination Score and Haemophilia Joint Health Score.
Measured: 45 minutes
pain condition
The pain condition will be examined in terms of pressure pain thresholds. By using an algometer device (Wagner Instruments, USA) with a robe area of 1 cm2 the individual pain sensitivity will be measured.
Measured: 15 minutes
subjective quality of life and subjective physical performance
The examination of these parameters is carried out by the standardised questionnaires SF-36 (quality of life) and the HEP-Test-Q (subjective physical performance).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start19 Aug 2020
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Mar 2023 (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 OsteoporosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PD Dr. Andreas Strauß
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor-investigator, PD Dr. Andreas Strauß, University Hospital, Bonn
- Investigators
- Andreas Strauß, PD Dr., Principal investigator, Medicine of the University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524481
- Sponsor's protocol ID
- NISOSTEO20200529
- Other IDs
- 2020-003072-41
- Status last verified
- Oct 2021
- First submitted
- 19 Aug 2020
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The publication of anonymous patient data is not allowed by informed consent.
Publications
Ransmann P, Bruhl M, Hmida J, Goldmann G, Oldenburg J, Schildberg FA, Ossendorff R, Tomschi F, Schmidt A, Hilberg T, Strauss AC. Physical activity and handgrip strength in patients with mild, moderate and severe haemophilia: Impacts on bone quality and lean mass. PLoS One. 2025 Mar 26;20(3):e0319951. doi: 10.1371/journal.pone.0319951. eCollection 2025.
PubMed 40138293
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporosis Screening in Adult Patients With Haemophilia and Influence of Physical Activity on the Prevalence of Osteoporosis
- ClinicalTrials.gov ID
- NCT04524481
- Acronym / sponsor ID
- NISOSTEO20200529
- Conditions
- Osteoporosis, Haemophilia, Bone Mass
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- PD Dr. Andreas StraußUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 24 Aug 2020 (actual)
- 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.
The aim of this study is to evaluate the prevalence of osteoporosis in adult patients with haemophilia.
Detailed description
The aim of this study is to evaluate the prevalence of osteoporosis in adult patients with haemophilia. Subsequently, the ascertained prevalence of osteoporosis in patients with haemophilia will be compared to the latest published data of osteoporosis in Germany. Furthermore, the impact of severity of haemophilia, comorbidities as well as the role of both physical activity and individual joint condition as influencing factors on the presence of osteoporosis will be analysed by this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with mild haemophilia A or B | – | –(FVIII or IX >5 %, ≥ 18 years' old) |
| Patients with moderate haemophilia A or B | – | –(FVIII or IX 1-5 %, ≥ 18 years' old) |
| Patients with severe haemophilia A or B | – | –(FVIII or IX <1 %, ≥ 18 years' old) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥ 18 years of age) suffering from mild (FVIII or IX >5 %), moderate (FVIII or IX 1-5 %) or severe (FVIII or IX <1 %) haemophilia A or B
Key inclusion criteria (2 listed)
- Adult patients (≥ 18 years of age) suffering from mild (FVIII or IX >5 %), moderate (FVIII or IX 1-5 %) or severe (FVIII or IX <1 %) haemophilia A or B
- Submitted written consent to participate in the study
Key exclusion criteria (4 listed)
- Patients suffering from other bleeding diseases
- PWH without written consent
- PWH < 18 years of age
- Secondary osteoporosis
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 mass/bone density maesurement
Time frame: 15 minutes
All patients with haemophilia of this study will receive a standardised bone density measurement by using the same dual energy X-ray absorptiometry (DXA) device.
blood sample (Vit. D/Calcium)
Time frame: 10 minutes
The blood samples of all patients with haemophilia will be tested according to the guidelines of the confederation of osteology (DVO). These blood samples are necessary to assess the osteoporosis by measuring the Vitamin-D and Calcium level.
5 secondary outcomes
haemophilia related clinical data
Time frame: 10 minutes
level of physical activity
Time frame: non determinable
orthopaedic joint status
Time frame: 45 minutes
pain condition
Time frame: 15 minutes
subjective quality of life and subjective physical performance
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Derived from this study: PubMed 40138293Ransmann P, Bruhl M, Hmida J, Goldmann G, Oldenburg J, Schildberg FA, Ossendorff R, Tomschi F, Schmidt A, Hilberg T, Strauss AC. Physical activity and handgrip strength in patients with mild, moderate and severe haemophilia: Impacts on bone quality and lean mass. PLoS One. 2025 Mar 26;20(3):e0319951. doi: 10.1371/journal.pone.0319951. eCollection 2025.
- Individual participant dataSharing planned: No. The publication of anonymous patient data is not allowed by informed consent.
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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.
Andreas Strauß, PD Dr. principal investigator
Medicine of the University of Bonn
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 Osteoporosis and Haemophilia, run by PD Dr. Andreas Strauß at 1 site in Germany.
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 2 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 29 Oct 2021. 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 Germany. 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 Andreas Strauß, PD Dr. (004922828714176, andreas.strauss@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone mass/bone density maesurement (time frame: 15 minutes). The study lists 2 primary outcomes in all. 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 NCT04524481, 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 29 Oct 2021.