A Study to Evaluate Bone Mineral Densities and Serological Markers to Assess Fracture Risk in Children and Young Adults with Bleeding Disorders
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-004095
About this study
The primary objectives of this study are to obtain serological bone turnover markers and bone mineral density (BMD) measurements from hemophilia A and von Willebrand disease (VWD) patients aged ≥ 6 to ≤ 25 years, to compare BMD measurements by HRpQCT and DXA with respect to severity of hemophilia A (mild, moderate, severe) and vWD, annualized bleeding rates, activity and joint scores, and to identify multivariate predictors (correlates) of BMD measurements, including serological bone turnover markers, biochemical and hormonal markers, chronological age, Tanner stage, gender, height, weight, BMI, type of bleeding disorder, severity of bleeding disorder, history of inhibitors, and joint bleeds.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients ≥ 6 to ≤ 25 years of age.
- Diagnosed with hemophilia A or vWD.
- Able to give informed consent (and assent as applicable).
Exclusion Criteria:
- Patients < 6 or > 25 years of age.
- No known diagnosis of hemophilia A or vWD.
- Inability or unwillingness to consent or undergo study activities.
- Use of medications known to impact bone and mineral metabolism (e.g., bisphosphonates, corticosteroids, estrogens, testosterone therapy, calcitonin, thyroid hormone therapy).
- Disease known to affect bone integrity (e.g., primary hyperparathyroidism, Pagets disease, clinically significant liver disease).
- Illicit drug use or alcohol use > 3 drinks/day.
- Weight > 350 pounds (the maximum weight limit of the DXA).
- Implanted hardware precluding scans.
- History of bilateral wrist fracture.
- Women who are currently pregnant or who become pregnant.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Rajiv Pruthi, M.B.B.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available