 |
||||||||||||
 |
 |
 |
 |
|||||||||
 |
||||||||||||
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
|||
 |
|
|
|
|
|
|
|
|
|
|
|
|
New Treatment Study on
Mild Osteogenesis Imperfecta
What is "mild osteogenesis imperfecta"?
Osteogenesis imperfecta (OI) is a disease with a very wide range of severity. Some people with OI have a large number of fractures, others have very few. "Mild osteogenesis imperfecta" means that there are two or fewer fractures per year and that the bones are straight. This form of osteogenesis imperfecta is often called "OI type I".
Who can participate?
Patients with osteogenesis imperfecta type I between 4 and 17 years of age can take part in this research study.
Why do we do this study?
At present there is no medical therapy with proven effectiveness in mild OI, so children with this form of the disease are currently untreated. The purpose of this study is to test whether children and adolescents with mild OI benefit from taking an Actonel® (risedronate) pill once per week.
How is the study done?
All participants of this study take one pill per week for a total of two years. Half of the patients receive the Actonel® pills, the other half receive similar-looking pills, but which do not contain the active drug (placebo). Neither the patients nor the doctors or nurses know who is taking what kind of pill. At the end of the two years we will compare whether patients who received Actonel® are doing any better than the patients who took the placebo pills. This kind of study is called a double-blind placebo-controlled trial. This study is sponsored by Procter & Gamble Pharmaceuticals and will include 50 patients.
Some more details on the medication
Actonel® is a drug that has been approved by Health Canada and the US Food and Drug Administration (FDA) for the treatment and prevention of osteoporosis (thinning of bone) in women after menopause. More information on the effects of Actonel® in adults can be found here. There is no experience on the use of Actonel® in children. However, results with drugs that are very similar to Actonel® suggest that this medication may be beneficial in the treatment of children and adolescents who have OI.
Interested ?
If you are interested in this study, you can get more information from our clinical study coordinator Sylvie Cornibert. You can also contact Sylvie at 1-800-361-7256 ext 7175, or 514-282-7175.