 |
||||||||||||
 |
 |
 |
 |
|||||||||
 |
||||||||||||
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
|||
 |
|
|
|
|
|
|
|
|
|
|
|
|
New Treatment Study on
Severe Osteogenesis Imperfecta
What is "severe 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. "Severe osteogenesis imperfecta" means that there are more than two fractures per year or that bones are curved.
Who can participate?
Patients with severe osteogenesis imperfecta up to 17 years of age can take part in this research study.
Why do we do this study?
At present children and adolescents with severe osteogenesis imperfecta are usually treated with intravenous infusions of Aredia® (pamidronate). This treatment makes bones stronger and decreases bone pain. However, the drawback of Aredia® is that the infusions take quite a long time (about 4 hours each). In addition, the infusions have to be given on three days in a row, every two to four months. Zometa® (zoledronic acid) is a drug that is similar to Aredia®, but which requires only one 45 minutes intravenous injection every 3 months.
How is the study done?
Participants of this study will either be treated with Zometa® or Aredia®. Thus, all patients will receive an active medication. The treatment will be randomized. This means that at the start of the study, each participant will be assigned to treatment with Zometa® or Aredia® on a chance basis, similar to throwing dice. Therefore, neither the patient nor the doctor will be able to choose which drug should be given. Infusions with Zometa® or Aredia® will be given in regular intervals. At the end of one treatment year we will compare whether there is any difference in the effectiveness of the two types of treatments. This is a multicenter international study sponsored by Novartis Pharmaceuticals. It will include 132 children in total and the principal study site is here in Montreal.
Some more details on the medication
Zometa ® is a drug that has been approved by Health Canada and the US Food and Drug Administration (FDA) for the treatment of adults with various bone diseases. More information on the effects of Zometa® in adults can be found here. There is no experience on the use of Zometa® in children. However, results with drugs that are very similar to Zometa® suggest that this medication may be beneficial in the treatment of children and adolescents who have a severe form of 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.