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Osteoporosis and MRI Study in Hemophilia

This study has been terminated.
Information provided by (Responsible Party):
Baxalta US Inc. Identifier:
First received: October 20, 2011
Last updated: June 26, 2015
Last verified: April 2012
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 Intervention
Bone Mineral Density Hemophilia A Hemophilia B Other: DXA scan + MRI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Bone and Joint Health in an Adult Hemophilia Population

Resource links provided by NLM:

Further study details as provided by Baxalta US Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 3
Study Start Date: October 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).


Ages Eligible for Study:   25 Years and older   (Adult, Senior)
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01460147

United States, California
Los Angeles Orthopedic Hospital
Los Angeles, California, United States, 90007
Sponsors and Collaborators
Baxalta US Inc.
Study Director: Linda Yamamoto, MD Baxter Healthcare Corporation
  More Information

Responsible Party: Baxalta US Inc. Identifier: NCT01460147     History of Changes
Other Study ID Numbers: 001001
Study First Received: October 20, 2011
Last Updated: June 26, 2015

Keywords provided by Baxalta US Inc.:

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 processed this record on September 21, 2017