Osteoporosis and MRI Study in Hemophilia

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	25 Years and older (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
Los Angeles Orthopedic Hospital
Los Angeles, California, United States, 90007

Sponsors and Collaborators

Baxalta now part of Shire

Investigators

Study Director:	Linda Yamamoto, MD	Baxter Healthcare Corporation

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Baxalta now part of Shire
ClinicalTrials.gov Identifier:	NCT01460147 History of Changes
Other Study ID Numbers:	001001
First Posted:	October 26, 2011
Last Update Posted:	October 23, 2017
Last Verified:	April 2012

Keywords provided by Shire ( Baxalta now part of Shire ):

Hemophilia

Additional relevant MeSH terms:

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