Osteoporosis and MRI Study in Hemophilia

Study Overview
=================
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.

Official Title
-----------------
Bone and Joint Health in an Adult Hemophilia Population

Conditions
-----------------
Bone Mineral Density, Hemophilia A, Hemophilia B

Intervention / Treatment
-----------------
* Other: DXA scan + MRI


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 25 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DXA scan + MRI<br> | Other: DXA scan + MRI<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Endpoint: Z-Score by dual-energy X-ray absorptiometry (DXA) at baseline |  | Baseline | 
| Longitudinal Endpoint: Change in bone mineral density by DXA over 2 years |  | 2 years | 
| Longitudinal Endpoint: Rate of loss of knee cartilage parameters over 2 years by MRI |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemophilia