Osteoporosis and MRI Study in Hemophilia

April 20, 2021 updated by: Baxalta now part of Shire

Bone and Joint Health in an Adult Hemophilia Population

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxalta now part of Shire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 30, 2011

Primary Completion (ACTUAL)

April 13, 2012

Study Completion (ACTUAL)

April 13, 2012

Study Registration Dates

First Submitted

October 20, 2011

First Submitted That Met QC Criteria

October 25, 2011

First Posted (ESTIMATE)

October 26, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2021

Last Update Submitted That Met QC Criteria

April 20, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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