Study title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study of One year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate, in Children ≥ 4 to < 16 Years Old with Osteogenesis Imperfecta
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Musculoskeletal Diseases | |||||
Brands: Please see report | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: RISEDRONIC ACID | |||||
ATC code: M05BA07 | |||||
Document link: Risedronate sodium - Study 1.pdf | |||||
Document date: 2011-11-07 | |||||
Study number: 2003100-HMR4003I/3001 | |||||
EudraCT number: 2004-000485-13 | |||||
Scope of study: Clinical | |||||
Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
- | - | - | Y | Y |