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Osteoporosis and MRI Study in Hemophilia

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ClinicalTrials.gov Identifier: NCT01460147
Recruitment Status : Terminated
First Posted : October 26, 2011
Last Update Posted : October 23, 2017
Sponsor:
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Bone Mineral Density Hemophilia A Hemophilia B Other: DXA scan + MRI Not Applicable

Study Design
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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

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Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. Baseline Endpoint: Z-Score by dual-energy X-ray absorptiometry (DXA) at baseline [ Time Frame: Baseline ]
  2. Longitudinal Endpoint: Change in bone mineral density by DXA over 2 years [ Time Frame: 2 years ]
  3. Longitudinal Endpoint: Rate of loss of knee cartilage parameters over 2 years by MRI [ Time Frame: 2 years ]

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

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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, California
Los Angeles Orthopedic Hospital
Los Angeles, California, United States, 90007
Sponsors and Collaborators
Baxalta now part of Shire
Investigators
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Study Director: Linda Yamamoto, MD Baxter Healthcare Corporation
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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
Keywords provided by Shire ( Baxalta now part of Shire ):
Hemophilia
Additional relevant MeSH terms:
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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