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
A Clinical Study of Heart Disease in Children and Adults who have OI To better understand the occurrence of heart and
blood vessel conditions in Osteogenesis Imperfecta (OI), the Bone and
Osteogenesis Imperfecta Department at the Kennedy Krieger Institute (KKI),
Baltimore, MD, is recruiting children and adults with OI who have a current or
previous diagnosis of heart valve problems, problems with the aorta or other
blood vessel problems, or who have had surgery for these disorders. For details
about the study, please visit http://osteogenesisimperfecta.org/OI-heart-research-project.php
Investigator: Jay Shapiro, MD Protocol
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.
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.
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 firstname.lastname@example.org.
National Institutes of Health (NIH) The osteogenesis imperfecta program at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) enrolls children with types III and IV OI. Under the direction of Dr. Joan Marini, this program has over 25 years experience providing comprehensive multidisciplinary evaluations and care for children with OI. Pediatric participants are offered follow-up into young adulthood. Four protocols are available.
Screening Protocol: Children are first admitted under this protocol for diagnostic and screening evaluations. Testing may include: skin biopsy, blood draw, X-rays or bone density scan (DEXA).
Natural History Protocol: Provides comprehensive evaluation and monitoring. Includes genetics, rehabilitation, physical therapy, developmental, bone and spine X-rays, bone density scans (DEXA), dental, hearing, pulmonary, cardiac and neurologic examination.
Pamidronate Dose Comparison Protocol: The goal of this protocol is to determine whether lower cumulative doses of pamidronate will deliver the same benefits as higher doses, with lower side effects. Children ages 2-16 years are randomized to receive pamidronate infusions at either 3 or 6 month intervals. All children enrolled in this protocol co-enroll in the Natural History protocol.
Growth Protocol: This protocol evaluates the effectiveness of growth hormone on improving growth and bone quality in children with OI. All children complete a year of pretreatment measurements and testing before beginning one year of growth hormone injections. After the first year of treatment, children who respond to growth hormone may continue treatment for additional years.
Participation in NIH studies is free of charge. To learn more contact Dr. Joan Marini.Phone Number: 301-496-0741 Email: email@example.com