Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Osteoporosis and MRI Study in Hemophilia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01460147
Recruitment Status : Terminated
First Posted : October 26, 2011
Last Update Posted : April 22, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Baxalta now part of Shire )

Study Description
Go to 
Top of Page 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Actual Study Start Date : October 30, 2011
Actual Primary Completion Date : April 13, 2012
Actual Study Completion Date : April 13, 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page 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
Go to 
Top of Page 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
United States, California
Los Angeles Orthopedic Hospital
Los Angeles, California, United States, 90007
Sponsors and Collaborators
Baxalta now part of Shire
Investigators
Layout table for investigator information
Study Director: Study Director Takeda
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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: April 22, 2021
Last Verified: April 2021
Keywords provided by Takeda ( Baxalta now part of Shire ):
Hemophilia
Additional relevant MeSH terms:
Layout table for 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