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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01460147
Other study ID # 001001
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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