OI: Forteo Study Extended:Recruiting Volunteers

ALT TITLE:Recruitment for the Forteo Study has Been Extended

Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta (OI)

NOTE: This study is available at Baylor University (Houston, Texas) and Oregon Health Sciences University (Portland, Oregon), and Kennedy Krieger Institute’s campus in Baltimore, Maryland. Please inquire if you would like to participate at another site.

We are writing to let you know about a research study for adults (age 18 or older) affected with Osteogenesis Imperfect (OI). The Kennedy Krieger Institute is doing this study to determine the effectiveness of teriparatide (FORTEO) in OI. FORTEO is currently approved by the FDA and marketed for the treatment of osteoporosis. The purpose of this study is to improve bone health and reduce fractures in adults affected with OI.

We are sending this letter because you are the parent(s) of an adult that has been diagnosed with OI, have OI yourself, may know someone with OI, and/or have indicated an interest in OI.

Qualified participants will receive bone density testing, spine x-rays, physical exams, calcium, vitamin D and study drug at no cost. This study will last 18 months, requiring an initial screening visit and six follow-up visits (about 1-1.5 hour each) every 3 months to the study site. However, we do not have funds for travel, so you are responsible for the cost of transportation to the OI Clinic.

All participants will have a 1 in 2 chance of getting either FORTEO or placebo, an inactive substance. All participants that receive placebo during the study will be offered the opportunity to receive FORTEO at no cost for 18 months at the end of the study.

TO QUALIFY FOR THIS RESEARCH STUDY:

 

  • You must be an adult, 18 years or older
  • You must be previously diagnosed with OI
  • You must not have a history of Paget’s disease
  • You must not have a history of bone cancer
  • You must not have taken bisphosphonate drugs like Fosamax, Actonel, etc. for the past 12 months
  • You must not be a pregnant female

 

You are invited to see if you qualify for the OI Study. If you are interested, please email or call the Forteo Nurse, Pamela Melvin, at 443 923 2707 or email at Melvin@kennedykrieger.org.

Sincerely,

Jay Shapiro, MD, Principal Investigator
Protocol Number: NA_00001038

IRB Approved 05/29/2008

Approved 05/29/2008

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