NCT01460147

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

October 30, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2012

Completed
Last Updated

April 22, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

October 20, 2011

Last Update Submit

April 20, 2021

Conditions

Bone Mineral DensityHemophilia AHemophilia B

Keywords

Hemophilia

Outcome Measures

Primary Outcomes (3)

  • Baseline Endpoint: Z-Score by dual-energy X-ray absorptiometry (DXA) at baseline

    Baseline

  • Longitudinal Endpoint: Change in bone mineral density by DXA over 2 years

    2 years

  • Longitudinal Endpoint: Rate of loss of knee cartilage parameters over 2 years by MRI

    2 years

Study Arms (1)

DXA scan + MRI

OTHER
Other: DXA scan + MRI

Interventions

DXA scan + MRIOTHER

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).

DXA scan + MRI

Eligibility Criteria

Age25 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Los Angeles Orthopedic Hospital

Los Angeles, California, 90007, United States

Location

MeSH Terms

Conditions

Hemophilia AHemophilia B

Interventions

Absorptiometry, PhotonMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesSpectrum Analysis

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2011

First Posted

October 26, 2011

Study Start

October 30, 2011

Primary Completion

April 13, 2012

Study Completion

April 13, 2012

Last Updated

April 22, 2021

Record last verified: 2021-04

Locations

US(1)