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Before deciding to participate in a research study, please review information on Participating in a Study and the fact sheet Medical Research Clinical Trials. It is always a good idea to discuss any changes to your health care program with medical professionals who are familiar with your health history.
Studies Currently Enrolling Participants.
Children and Adults with OI
Bone and Vibration Treatment Study
The AI
duPont Hospital for Children in Wilmington, DE and the University of Delaware
in Newark, DE.
This is a
study of the effect of a daily vibration treatment on bone health of children
with osteogenesis imperfecta. There is no charge for participation. Eligibility:
Children 5 – 10 years of age with a diagnosis of mild OI, without
intramedullary rods in the tibia or femur and not treated with bisphosphonates
during the past year.
For more
information contact Dr. Michael Bober at 302-651-5916, mbober@nemours.org or Lauren
Davey, PA-C at 302-651-5916, ldavey@nemours.org
(Posted April
2010)
Natural History of OI Study
“The Longitudinal Study of Osteogenesis Imperfecta” is a project of the OI Foundation’s Linked Clinical Research Centers (LCRC). Six centers across the United States plus one in Canada are enrolling children and adults into this study. People of all ages and all types of OI are needed. Study participants are required to visit the Linked Center once a year for 5 years. Each person will be asked for a detailed medical history and receive an extensive annual physical exam including various diagnostic studies such as a DEXA. For more details about this study and the participating centers see the detailed description. Natural History of OI Study.
Children with OI
OI Nutrition Study
Three medical centers will be collaborating on this study to evaluate the effect of diet on growth rates and bone mass in children who have OI--the Kennedy Krieger Institute, Baltimore, MD, the duPont Hospital for Children, Wilmington, DE, and the Children's Hospital, Philadelphia, PA. The Kennedy Krieger Institute is currently recruiting participants. Participants will be asked to complete surveys about their child's diet. There is no charge for participation. Eligibility: Children 2-10 years of age, with a diagnosis of osteogenesis imperfecta are eligible to participate.
For more information: Contact Pamela Melvin, RN at (443) 923-2707 or visit Kennedy Krieger Nutrition Study.
Ongoing Studies
Adults with OI: Teriparatide (©Forteo)
Three centers across the United States – The Kennedy Krieger Institute, Baltimore, MD; Baylor University, Houston, TX; and The Oregon Health Science University, Portland, OR -- are participating in a study on the effectiveness and safety of teriparatide (©Forteo) as a treatment for adults with OI. This drug is currently approved by the Food and Drug Administration for use by adults with osteoporosis. It is taken as an injection once a day. Eligibility: Adults age 18-85 years old, who have not been taking any medications that could affect bone density for the past 12 months. This study has entered the data analysis stage and no new patients are being enrolled at this time.
Bisphosphonates
Bisphosphonates continue to be studied as a treatment for infants, children, and adults who have OI. Questions about the most effective dose and long term use remain to be answered. The OI Foundation’s Medical Advisory Council encourages anyone who is interested in using these drugs as part of managing OI to either participate in a clinical trial or to have their doctor correspond with an OI researcher.
Linked Clinical Research Centers (LCRC)
The LCRC is a group of six Centers governed by a Coordinating Committee and linked together through a secure central database. The program is designed to collect comprehensive health history information from children and adults who have osteogenesis imperfecta. People of all types of OI and all ages are encouraged to enroll in LCRC studies. The centers are currently enrolling participants in a Longitudinal Study of Osteogenesis Imperfecta. The state-of-the-art database stores patient information in a secure and anonymous fashion and allows in-depth analysis of the contents. The LCRC program also offers care to adults and children with OI, as well as provides training and information to physicians and researchers. The LCRC is co-funded by the national OIF and the Chicago-based Children’s Brittle Bone Foundation (CBBF) through private donations to these foundations.
National Institutes of Health (NIH)
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has a long standing, pediatric focused program for children with Types III and IV OI. Participation in NIH studies is free of charge. To learn more about OI studies at the NIH that are currently enrolling participants, features of the studies and eligibility please contact Catherine Reisenberg, FNP, PhD at (301) 496-0741 or oiprogram@mail.nih.gov.
OI Registry
The OI Registry promotes research into OI and connects members with studies. Adults who have OI and parents of children who have OI are encouraged to join by completing a simple on-line questionnaire. All data is kept in a secure data base. This program is free of charge and open to people who have OI in the United States and around the world. For more information or to obtain a paper registration form contact the Registry Manager at phone number (443) 923-9180 or e-mail at oiregistrymanager@kennedykrieger.org.
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