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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  07/23/2009
 
Trade Name:  Actonel
 
Generic or Proper Name (*):  risedronate
 
Indications Studied:  Osteogenesis imperfecta
 
Therapeutic Category:  Bone density
 
Ages Studied:  4-<16 years
 
Study #:  1
 
Study Type:  Safety/Pharmacokinetic/Tolerability
 
Study Design:  Open Label/Traditional Pharmacokinetic
 
No Patients:  28
 
No Centers:  1
 
No Countries:  1
 
BPCA(B), PREA(P):  B
 
Asian:  2
 
Black:  1
 
Other:  0
 
White:  25
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
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