Osteoporosis and MRI Study in Hemophilia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01460147 |
Recruitment Status :
Terminated
First Posted : October 26, 2011
Last Update Posted : October 23, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bone Mineral Density Hemophilia A Hemophilia B | Other: DXA scan + MRI | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Bone and Joint Health in an Adult Hemophilia Population |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | April 2012 |
Actual Study Completion Date : | April 2012 |

Arm | Intervention/treatment |
---|---|
DXA scan + MRI |
Other: DXA scan + MRI
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). |
- 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 ]

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Ages Eligible for Study: | 25 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460147
United States, California | |
Los Angeles Orthopedic Hospital | |
Los Angeles, California, United States, 90007 |
Study Director: | Linda Yamamoto, MD | Baxter Healthcare Corporation |
Responsible Party: | Baxalta now part of Shire |
ClinicalTrials.gov Identifier: | NCT01460147 |
Other Study ID Numbers: |
001001 |
First Posted: | October 26, 2011 Key Record Dates |
Last Update Posted: | October 23, 2017 |
Last Verified: | April 2012 |
Hemophilia |
Hemophilia A Hemophilia B Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases |
Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn Genetic Diseases, X-Linked |