Osteoporosis and MRI Study in Hemophilia

Hemophilia A Clinical Trial

Official title:

Bone and Joint Health in an Adult Hemophilia Population

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01460147
• Other study ID #: 001001
• Status: Terminated
• Phase: N/A
• Start date: October 30, 2011
• Est. completion date: April 13, 2012

Study information

• Verified date: April 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 13, 2012
• Est. primary completion date: April 13, 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bone Mineral Density
• Hemophilia A
• Hemophilia B

Intervention

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).

Locations

Country	Name	City	State
United States	Los Angeles Orthopedic Hospital	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Baxalta now part of Shire

Country where clinical trial is conducted

United States, 

Outcome

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