Dettagli per singolo studio

DEC-NET Serial number GB386

Published online	11/04/2005 12.07.00
Last updated	10/04/2006 10.13.31

Other protocol ID number	N0220093130
This trial has been approved by an ethics committee
Current trial status	Closed to recruitment of participants: follow-up continuing
Target N. of subjects	66
Major Disease (ICD9 class)	OSTEOGENESIS IMPERFECTA
Experimental drug
Risedronate Treatment regimen (dosage and duration) randomised to receive 0.2, 1 or 2mg/kg/week of risedronate for 2 years (double-blind part of the study), followed by 1mg/kg/week for 1 year (open label part of the study).
Gender	Both
Age (range)	4 - 17 years
Eligibility criteria
Inclusion criteria
Any child with ostegenesis imperfecta at high risk for fractures as defined by a history of at least 2 non-traumatic or low impact fractures within 2 years of enrollment and at least one of the following factors related to disease severity :- musculoskeletal pain poor mobility as a result of fractures and/or pain history of a surgical procedure related to bone fractures or bone deformities Must be able to remain upright without food for 30 minutes after taking medication
Exclusion criteria
History of intolerance of or allergic reaction to risedronate
Trial design/methodology
Phase	3
Kind of study	Efficacy
Design	Controlled Randomised Blinded Double blind
Purpose of study
A double-blind randomised controlled study to compare different doses of risedronte in children who suffer from osteogenesis imperfecta
Primary outcomes
Change in lumbar spine bone mineral density z-score Number of fractures
Secondary outcomes
Total body bone mass, lumbar spine bone area, vertebral height, pain, mobility
Summary of study design, objectives, and ongoing research findings
Comparison of the dose response of risedronate in children with osteogenesis imperfecta.