Status:
TERMINATED
Osteoporosis and MRI Study in Hemophilia
Lead Sponsor:
Baxalta now part of Shire
Conditions:
Bone Mineral Density
Hemophilia A
Eligibility:
MALE
25+ years
Phase:
NA
Brief 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 u...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 \[defined as 7.5-mg prednisone daily (or equivalent) for \>= 3 months\]
- 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)
Key Trial Info
Start Date :
October 30 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2012
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01460147
Start Date
October 30 2011
End Date
April 13 2012
Last Update
April 22 2021
Active Locations (1)
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1
Los Angeles Orthopedic Hospital
Los Angeles, California, United States, 90007