Bone Mineral DensityNCT01460147
Osteoporosis and MRI Study in Hemophilia
A study testing DXA scan + MRI in people with Bone Mineral Density and Hemophilia A, run by Baxalta now part of Shire at 1 site in United States.
Trial summary
The purpose of this study is to evaluate bone mineral density in adult subjects with hemophilia versus a comparator population without hemophilia (non-hemophilia age- and gender-matched database) by using the following diagnostic means: dual-energy X-ray absorptiometry (DXA) scanning, clinical scales, quality of life… Read more about this study
- Who is it for?
- Ages 25 years and older, men only
- Conditions the study is for
- Bone Mineral Density, Hemophilia A, Hemophilia B
- What is being tested?
- DXA scan + MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2011to 13 Apr 2012
- Phase
- Interventional
- 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 25 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and at least 25 years old at the time of screening
- Moderately severe or severe hemophilia A or B (factor VIII or factor IX <= 2% by chart documentation)
- Ambulatory (ie, not wheel chair dependent)
- Performance status - ECOG of 0 or 1 (= out of bed at least 75% of time)
- Willing and able to comply with the requirements of the protocol and is able to give informed consent
- Additional inclusion criteria for MRI Substudy:
- Baseline knee joint space width is >= 3mm at the medial or lateral aspect of either knee as measured by weightbearing fixed flexion PA X-ray
- Able to undergo 1.5 or 3T MRI
Who cannot join
- Inability to position properly for DXA
- Presence of orthopedic hardware or other artifact in the lumbar spine (L1-L4) or either proximal femur
- Prior documentation of being HIV positive
- Radiosynovectomy or surgical synovectomy within the last 6 months
- Current or past treatment with bone active drugs
- Long-term corticosteroid use [defined as 7.5-mg prednisone daily (or equivalent) for >= 3 months]
Show all 12Show fewer
- If subject is family member or employee of the investigator
- Additional exclusion criteria for MRI Substudy:
- Any contraindication or relative contraindication to MRI
- Less than 3mm knee joint space width at the medial and lateral aspect of both knees on baseline X-ray evaluation
- Knee bleed within 30 days of informed consent
- Prior total knee arthroplasty (TKA)
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles Orthopedic Hospital
Los Angeles, California, 90007
About this study
Official title: Bone and Joint Health in an Adult Hemophilia Population
The purpose of this study is to evaluate bone mineral density in adult subjects with hemophilia versus a comparator population without hemophilia (non-hemophilia age- and gender-matched database) by using the following diagnostic means: dual-energy X-ray absorptiometry (DXA) scanning, clinical scales, quality of life (QOL) scales and biomarkers. In addition to this osteoporosis study, hemophilic arthropathy of the knee with respect to loss of knee cartilage will also be explored by using magnetic resonance imaging (MRI substudy). No investigational product will be dispensed.
- Conditions
- Bone Mineral Density, Hemophilia A, Hemophilia B
- Being tested
- DXA scan + MRI
- Keywords
- Hemophilia
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXA scan + MRIOther
This is a non-drug study. Subjects will receive a dual-energy X-ray absorptiometry (DXA) scan (in the main osteoporosis study) and will undergo magnetic resonance imaging (in the MRI substudy).
| Study group | Role | What they receive |
|---|---|---|
| DXA scan + MRI | Other | Not described Receives: Other: DXA scan + MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Endpoint: Z-Score by dual-energy X-ray absorptiometry (DXA) at baseline
Measured: Baseline
Longitudinal Endpoint: Change in bone mineral density by DXA over 2 years
Measured: 2 years
Longitudinal Endpoint: Rate of loss of knee cartilage parameters over 2 years by MRI
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study start30 Oct 2011
- Primary completion13 Apr 2012
- Study completion13 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Mineral DensityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460147
- Sponsor's protocol ID
- 001001
- Status last verified
- Apr 2021
- First submitted
- 20 Oct 2011
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone and Joint Health in an Adult Hemophilia Population
- ClinicalTrials.gov ID
- NCT01460147
- Acronym / sponsor ID
- 001001
- Conditions
- Bone Mineral Density, Hemophilia A, Hemophilia B
- Keywords
- Hemophilia
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2011 (actual)
- Primary completion
- 13 Apr 2012 (actual)
- Study completion
- 13 Apr 2012 (actual)
- First posted
- 26 Oct 2011 (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.
The purpose of this study is to evaluate bone mineral density in adult subjects with hemophilia versus a comparator population without hemophilia (non-hemophilia age- and gender-matched database) by using the following diagnostic means: dual-energy X-ray absorptiometry (DXA) scanning, clinical scales, quality of life (QOL) scales and biomarkers. In addition to this osteoporosis study, hemophilic arthropathy of the knee with respect to loss of knee cartilage will also be explored by using magnetic resonance imaging (MRI substudy). No investigational product will be dispensed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DXA scan + MRI | Other | Other: DXA scan + MRI |
Who may qualify
- Ages
- 25 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and at least 25 years old at the time of screening
- Moderately severe or severe hemophilia A or B (factor VIII or factor IX <= 2% by chart documentation)
- Ambulatory (ie, not wheel chair dependent)
- Performance status - ECOG of 0 or 1 (= out of bed at least 75% of time)
- Willing and able to comply with the requirements of the protocol and is able to give informed consent
Key exclusion criteria (12 listed)
- Inability to position properly for DXA
- Presence of orthopedic hardware or other artifact in the lumbar spine (L1-L4) or either proximal femur
- Prior documentation of being HIV positive
- Radiosynovectomy or surgical synovectomy within the last 6 months
- Current or past treatment with bone active drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DXA scan + MRIThis is a non-drug study. Subjects will receive a dual-energy X-ray absorptiometry (DXA) scan (in the main osteoporosis study) and will undergo magnetic resonance imaging (in the MRI substudy). | Other | DXA scan + MRI |
Primary outcome
Baseline Endpoint: Z-Score by dual-energy X-ray absorptiometry (DXA) at baseline
Time frame: Baseline
Longitudinal Endpoint: Change in bone mineral density by DXA over 2 years
Time frame: 2 years
Longitudinal Endpoint: Rate of loss of knee cartilage parameters over 2 years by MRI
Time frame: 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
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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.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DXA scan + MRI in people with Bone Mineral Density and Hemophilia A, run by Baxalta now part of Shire at 1 site in United States.
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 8 inclusion and 12 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: stopped early, as of the sponsor's last update on 22 Apr 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 United States. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Endpoint: Z-Score by dual-energy X-ray absorptiometry (DXA) at baseline (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2021.