Osteoporosis and MRI Study in Hemophilia

Bone and Joint Health in an Adult Hemophilia Population

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01460147

Enrollment

Registered

2011-10-26

Start date

2011-10-30

Completion date

2012-04-13

Last updated

2021-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Mineral Density, Hemophilia A, Hemophilia B

Keywords

Hemophilia

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.

Interventions

OTHERDXA 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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

25 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026