Risedronate treatment for Children with severe Osteogenesis Imperfecta

ISRCTN	ISRCTN76376467
DOI	https://doi.org/10.1186/ISRCTN76376467
Protocol serial number	B0696
Sponsor	Arthritis Research Campaign (ARC) (UK)
Funders	Arthritis Research Campaign (ARC) (UK), Alliance for Better Bone Health (UK)

Submission date: 04/02/2002
Registration date: 04/02/2002
Last edited: 03/11/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Nick Bishop
Scientific

Institute of Child Health
University of Sheffield
Children's Hospital
Western Bank
Sheffield
S10 2TH
United Kingdom

Phone	+44 (0)114 271 7677
Email	n.j.bishop@sheffield.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Bisphosphonate administration in children with severe osteogenesis imperfecta: A prospective randomised double blind controlled study of risedronate
Study acronym	RICO trial
Study objectives	Children aged between four and seventeen who have osteogenesis imperfecta, which is a form of osteoporosis which causes multiple fractures, deformity and stunted growth, are to be offered Risedronate in a clinical trial aimed at increasing bone density.
Ethics approval(s)	South Sheffield Research Ethics Committee. Date of approval: 06/12/1999 (ref: SS 98/183)
Health condition(s) or problem(s) studied	Osteogenesis imperfecta
Intervention	Patients will be randomised to either low (0.2 mg/kg/week), medium (1 mg/kg/week) or high (2 mg/kg/week) dose of the bisphosphonate risedronate. Treatment will continue for 3 years.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Bisphosphonate risedronate
Primary outcome measure(s)	Added as of 10/04/2008: Number of incident non-vertebral fractures in each group at 2 years.
Key secondary outcome measure(s)	Added as of 10/04/2008: The following were assessed at 2 years: 1. Total body and lumbar spine bone area 2. Bone mineral content 3. Areal bone mineral density and volumetric bone mineral density
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Years
Upper age limit	17 Years
Sex	All
Target sample size at registration	53
Key inclusion criteria	Inclusion criteria amended as of 15/04/2008: 1. Children with osteogenesis imperfecta 2. Aged between 3 and 17 ("Aged between 4 and 17" at ethics approval. We subsequently had an approved amendment to reduce the lower age limit to 3 years; this applied to only one child) 3. Both male and female Inclusion criterion provided at time of registration: Children with osteogenesis imperfecta
Key exclusion criteria	Added as of 10/04/2008: 1. Have a history of cancer 2. Have untreated rickets within one year prior to enrollment 3. Evidence of clinically significant organic or psychiatric disease on history or physical examination which in the opinion of the investigator would prevent the patient from completing the study 4. Have markedly abnormal pretreatment laboratory findings, except if in the opinion of the investigator, it would not prevent the patient from completing the study 5. Have a history of using anabolic steroids/estrogens/androgens within one year of enrollment 6. Have a history of using any of the following medications within 6 month of starting study drug for more than one month: calcitonin, vitamin D supplements >1000 IU per day, and calcitriol >1.5 mg/week 7. Have a history of using any bisphosphonate (except for more than a single dose of risedronate) and/or fluoride (>10 mg per day). Have a documented history of an abnormal or allergic reaction to bisphosphonates 8. Pregnancy or sexually active subjects unwilling to take appropriate contraceptive measures 9. Any limb-lengthening procedure within 6 of enrollment 10. Participation in another clinical trial, involving active intervention within 30 days prior to enrollment 11. Serum creatinine >150 µmol/L
Date of first enrolment	31/07/2001
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Institute of Child Health

Sheffield
S10 2TH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2010		Yes	No