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Osteoporosis and MRI Study in Hemophilia

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01460147
First received: October 20, 2011
Last updated: April 13, 2012
Last verified: April 2012
History of Changes
  Purpose

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: Open Label
Primary Purpose: Diagnostic
Official Title: Bone and Joint Health in an Adult Hemophilia Population

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Baseline Endpoint: Z-Score by dual-energy X-ray absorptiometry (DXA) at baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Longitudinal Endpoint: Change in bone mineral density by DXA over 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Longitudinal Endpoint: Rate of loss of knee cartilage parameters over 2 years by MRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: October 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2015 (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).

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460147

Locations
United States, California
Los Angeles Orthopedic Hospital
Los Angeles, California, United States, 90007
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Linda Yamamoto, MD Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01460147     History of Changes
Other Study ID Numbers: 001001
Study First Received: October 20, 2011
Last Updated: April 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Baxter Healthcare Corporation:
Hemophilia

Additional relevant MeSH terms:
Hemophilia B
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked

ClinicalTrials.gov processed this record on May 16, 2013