Supporting research is an important part of
the OI Foundation’s mission. Often, the success of clinical studies of a rare
disorder like osteogenesis imperfecta (OI) depends on getting enough people to
participate in the study so the results are meaningful. People who are
interested in participating in a clinical trial are encouraged to review the
fact sheet What You Need to Know about Clinical Studies.Additional information
about research studies can be found on www.clinicaltrials.gov.
The following Studies
are currently enrolling participants.
See the contact person for each study for detailed information
about who is eligible to participate and other study information.
October 2016 -- Interview Study Seeking Adults Living with OI
If you are an adult with OI, you may be eligible to participate in an interview study sponsored by Mereo Pharmaceuticals. The purpose of this study is to better understand OI symptoms and impacts in adults, and to provide feedback on a new questionnaire. The interview will last approximately 90 minutes. There is no medical treatment being provided as part of this study. If selected to participate, you will be compensated for your time. For more information, please call 1-866-893-0282 or e-mail at OIstudy@iconplc.com. The OI Foundation is not involved in the design or management of this questionnaire, and as such, is neither endorsing nor supporting this study. This study is different from the Brittle Bone Disorders Consortium (BBDC) Quality of Life Study. The mission of the OIF is to keep the OI community informed of all relevant studies. We are available to answer questions on this or any other research announcement. Please contact the OI Foundation at (301) 947-0083 or firstname.lastname@example.org if you have any questions.
October 2016 -- Vision Study/OI and the Eye
This study is being conducted by Dr. Felix Chau, University of Illinois
at Chicago, Illinois Eye and Ear Infirmary. The study seeks to understand more
clearly how different OI types affect the eyes and vision. This will help
families, OI adults and eye doctors take actions to keep eyes healthy and
respond correctly if a problem emerges. Individuals with OI age 18 or older are
eligible to participate. They are asked to:
Participants are reminded to
answer the question about OI Type, but NOT to include their name or other
personal information to protect privacy.
October 2016 -- Denosumab Treatment in Children with OI
Pharmaceutical Company is sponsoring an international clinical trial to study
the effects of the drug Denosumab on bone mineral and fracture occurrence in
children who have OI. Denosumab is a prescription medication that is sold under
the name Prolia®. It is currently used to treat post-menopausal osteoporosis
through twice a year injections. Forty sites in the United States and multiple
other countries will be participating in this study. Children ages 2-17 years who
have a diagnosis of OI Type I, III or IV are eligible for this 3 year study. To
learn more about this study and to see a complete list of study sites, you can
visit the study page on the Clinical Trials Website. This information is provided as a service. The OI Foundation is not a sponsor
of this study and did not assist in its design. (Posted July 2015, updated October 2016)
Brittle Bone Disorders Consortium
Natural History Study of OI
The Linked Clinical Research
Centers program (LCRC), established by the OI Foundation and the Children’s
Brittle Bone Foundation started a major longitudinal or natural history study
of OI. The Longitudinal Study of Osteogenesis Imperfecta has been
extended and expanded through the Brittle Bone Disorders Consortium. The
purpose of this study is to collect information about the experiences of people
with all types of OI across the entire life-span. Five centers in the United
States and one in Canada are enrolling
children and adults into this study. People of all ages and all types of OI
are needed. Participants
in the original study are encouraged to re-enroll at the site they had been
using or at one of the newly added sites. If you were in the first study
and have not been contacted by the study coordinator, please call them or call
the OI Foundation. Study participants will receive an annual physical and
various diagnostic studies. For details about the study and the participating
centers seeLongitudinal Study of OI
at the 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
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