Condition category
Musculoskeletal Diseases
Date applied
04/02/2002
Date assigned
04/02/2002
Last edited
03/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Professor Nick Bishop

ORCID ID

Contact details

Institute of Child Health
University of Sheffield
Children's Hospital
Western Bank
Sheffield
S10 2TH
United Kingdom
+44 (0)114 271 7677
n.j.bishop@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

B0696

Study information

Scientific title

Bisphosphonate administration in children with severe osteogenesis imperfecta: A prospective randomised double blind controlled study of risedronate

Acronym

RICO trial

Study hypothesis

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

South Sheffield Research Ethics Committee. Date of approval: 06/12/1999 (ref: SS 98/183)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Bisphosphonate risedronate

Primary outcome measures

Added as of 10/04/2008:
Number of incident non-vertebral fractures in each group at 2 years.

Secondary outcome measures

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

Overall trial start date

31/07/2001

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Added as of 10/04/2008: Planned recruitment: 60; Actual recruitment: 53

Participant 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

Recruitment start date

31/07/2001

Recruitment end date

31/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Child Health
Sheffield
S10 2TH
United Kingdom

Sponsor information

Organisation

Arthritis Research Campaign (ARC) (UK)

Sponsor details

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
-
info@arc.org.uk

Sponsor type

Charity

Website

http://www.arc.org.uk

Funders

Funder type

Charity

Funder name

Arthritis Research Campaign (ARC) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Alliance for Better Bone Health (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19580461

Publication citations

  1. Results

    Bishop N, Harrison R, Ahmed F, Shaw N, Eastell R, Campbell M, Knowles E, Hill C, Hall C, Chapman S, Sprigg A, Rigby A, A randomized, controlled dose-ranging study of risedronate in children with moderate and severe osteogenesis imperfecta., J. Bone Miner. Res., 2010, 25, 1, 32-40, doi: 10.1359/jbmr.090712.

Additional files

Editorial Notes