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Osteoporosis and MRI Study in Hemophilia

Primary Purpose

Bone Mineral Density, Hemophilia A, Hemophilia B

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DXA scan + MRI
Sponsored by
Baxalta now part of Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bone Mineral Density focused on measuring Hemophilia

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Los Angeles Orthopedic Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

DXA scan + MRI

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 20, 2011
Last Updated
April 20, 2021
Sponsor
Baxalta now part of Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01460147
Brief Title
Osteoporosis and MRI Study in Hemophilia
Official Title
Bone and Joint Health in an Adult Hemophilia Population
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Study Start Date
October 30, 2011 (Actual)
Primary Completion Date
April 13, 2012 (Actual)
Study Completion Date
April 13, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxalta now part of Shire

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Mineral Density, Hemophilia A, Hemophilia B
Keywords
Hemophilia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DXA scan + MRI
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
DXA scan + MRI
Intervention Description
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).
Primary Outcome Measure Information:
Title
Baseline Endpoint: Z-Score by dual-energy X-ray absorptiometry (DXA) at baseline
Time Frame
Baseline
Title
Longitudinal Endpoint: Change in bone mineral density by DXA over 2 years
Time Frame
2 years
Title
Longitudinal Endpoint: Rate of loss of knee cartilage parameters over 2 years by MRI
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Los Angeles Orthopedic Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90007
Country
United States

12. IPD Sharing Statement

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Osteoporosis and MRI Study in Hemophilia

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