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Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT00106028
Date of registration:	18/03/2005
Prospective Registration:	No
Primary sponsor:	Warner Chilcott
Public title:	Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
Scientific title:	Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
Date of first enrolment:	November 2004
Target sample size:	143
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00106028
Study type:	Interventional
Study design:
Phase:	Phase 3

Countries of recruitment
Australia	Belgium	Chile	Czech Republic	Finland	Germany	Hungary	Italy
Poland	South Africa	Spain	United Kingdom	United States

Contacts

Name:	Dietrich H Wenderoth, MD
Address:
Telephone:
Email:
Affiliation:	Procter and Gamble

Key inclusion & exclusion criteria

Inclusion Criteria:

- OI diagnosis

- increased risk of fracture: either has a history of at least 1 radiographically
confirmed, non-traumatic or low impact fracture plus low bone mineral density (BMD) or
has very low BMD with or without a history of fractures.

Exclusion Criteria:

- Any bisphosphonate use within one year of enrollment

Age minimum: 4 Years
Age maximum: 15 Years
Gender: All

Health Condition(s) or Problem(s) studied

Osteogenesis Imperfecta

Intervention(s)

Drug: risedronate sodium (Actonel)

Drug: Placebo

Primary Outcome(s)

Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population [Time Frame: Baseline and Month 12]

Secondary Outcome(s)

New Morphometric Vertebral Fracture at Month 12, ITT Population [Time Frame: Baseline and Month 12]

Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population [Time Frame: Baseline and Month 24]

Percent Change From Baseline in Total Body BMC at Month 12, ITT Population [Time Frame: Baseline and Month 12]

Percent Change From Baseline in Total Body BMC at Month 24, ITT Population [Time Frame: Baseline and Month 24]

Bone Age (Years), Change From Baseline to Month 12, ITT Population [Time Frame: Baseline and Month 12]

Bone Age (Years), Change From Baseline to Month 36, ITT Population [Time Frame: Baseline and Month 36]

Number of Clinical Fractures, Month 12, ITT Population [Time Frame: 12 Months]

Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population [Time Frame: Baseline and Month 36]

Percent Change From Baseline in Total Body Bone Area Month 24, ITT Population [Time Frame: Baseline and Month 24]

Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population [Time Frame: Baseline and Month 24]

Percent Change From Baseline in Total Body BMD at Month 24, ITT Population [Time Frame: Baseline and Month 24]

Annualized Growth Velocity - Change From Baseline to Month 12, ITT Population [Time Frame: Baseline and Month 12]

Bone Age (Years), Change From Baseline to Month 24, ITT Population [Time Frame: Baseline and Month 24]

Annualized Growth Velocity - Change From Baseline to Month 36, ITT Population [Time Frame: Baseline and Month 36]

Lumbar Spine Z-score - Percent Change From Baseline to Month 24, ITT Population [Time Frame: Baseline and Month 24]

Percent Change From Baseline in Total Body BMD at Month 12, ITT Population [Time Frame: Baseline and Month 12]

Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population [Time Frame: Baseline and Month 36]

Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT [Time Frame: Baseline and Month 12]

New Morphometric Vertebral Fracture at Month 36, ITT Population [Time Frame: Baseline and Month 36]

Serum BAP - Percent Change From Baseline to Month 24, ITT Population [Time Frame: Baseline and 24 Months]

Total Body Z-score- Percent Change From Baseline to Month 36, ITT Population [Time Frame: Baseline and Month 36]

Percent Change From Baseline in Lumbar Spine Bone Area at Month 36, ITT Population [Time Frame: Baseline and Month 36]

Percent Change From Baseline in Total Body Bone Area Month 12, ITT Population [Time Frame: Baseline and Month 12]

Urine NTX/Cr - Percent Change From Baseline at Month 36, ITT Population [Time Frame: Baseline and Month 36]

Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population [Time Frame: Time to First Event (days) up to 12 Months]

Serum BAP - Percent Change From Baseline to Month 36, ITT Population [Time Frame: Baseline and 36 Months]

Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT [Time Frame: Baseline and Month 36]

Urine NTX/Cr - Percent Change From Baseline at Month 24, ITT Population [Time Frame: Baseline and Month 24]

Wong-Baker FACES Pain Rating Scale - Change From Baseline to Month 12, ITT Population [Time Frame: Baseline and Month 12]

Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population [Time Frame: Month 12]

Lumbar Spine Z-score - Percent Change From Baseline to Month 36, ITT Population [Time Frame: Baseline and Month 36]

Percent Change From Baseline in Lumbar Spine Bone Area at Month 24, ITT Population [Time Frame: Baseline and Month 24]

Percent Change From Baseline in Total Body BMC at Month 36, ITT Population [Time Frame: Baseline and Month 36]

Percent Change From Baseline in Total Body Bone Area Month 36, ITT Population [Time Frame: Baseline and Month 36]

Total Body Z-score- Percent Change From Baseline to Month 12, ITT Population [Time Frame: Baseline and Month 12]

Total Body Z-score- Percent Change From Baseline to Month 24, ITT Population [Time Frame: Baseline and Month 24]

Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population [Time Frame: Month 12]

Lumbar Spine Z-score - Percent Change From Baseline to Month 12, ITT Population [Time Frame: Baseline and Month 12]

Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population [Time Frame: Baseline and Month 12]

Percent Change From Baseline in Lumbar Spine Bone Area at Month 12, ITT Population [Time Frame: Baseline and Month 12]

Percent Change From Baseline in Total Body BMD at Month 36, ITT Population [Time Frame: Baseline and Month 36]

Serum BAP - Percent Change From Baseline to Month 12, ITT Population [Time Frame: Baseline and 12 Months]

Urine NTX/Cr - Percent Change From Baseline at Month 12, ITT Population [Time Frame: Baseline and Endpoint / Month 12]

Secondary ID(s)

HMR4003I/3001

2003100

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	28/06/2010
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00106028

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