Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00106028 |
Recruitment Status :
Completed
First Posted : March 21, 2005
Results First Posted : June 28, 2010
Last Update Posted : April 22, 2013
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Sponsor:
Warner Chilcott
Information provided by (Responsible Party):
Warner Chilcott
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Osteogenesis Imperfecta |
Interventions |
Drug: risedronate sodium (Actonel) Drug: Placebo |
Enrollment | 143 |
Participant Flow
Recruitment Details | 147 children > or = 4 and < 16 years of age with Osteogenesis Imperfecta (OI) enrolled at 20 North American and international study centers starting 16NOV2004. Patients weighing 10-30 kg received risedronate 2.5 mg or placebo daily and patients weighing more than 30 kg received risedronate 5 mg or placebo daily. |
Pre-assignment Details |
Arm/Group Title | Placebo Daily | Risedronate Daily |
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placebo tablet, once a day for one year then for two years open label risedronate | risedronate tablet, once a day for one year then for two years open label risedronate once a day |
Period Title: Overall Study | ||
Started | 49 [1] | 94 [1] |
Month 12 Completed/Started Open Label | 49 | 87 |
Completed | 43 [2] | 82 [2] |
Not Completed | 6 | 12 |
Reason Not Completed | ||
Adverse Event | 3 | 2 |
Protocol Violation | 1 | 1 |
Withdrawal by Subject | 2 | 8 |
Lost to Follow-up | 0 | 1 |
[1]
ITT Population: Patients Randomized and Received at least 1 Dose of Study Drug
[2]
Completed Month 36
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Baseline Characteristics
Arm/Group Title | Placebo Daily | Risedronate Daily | Total | |
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placebo tablet, once a day for one year then for two years open label risedronate | risedronate tablet, once a day for one year then for two years open label risedronate once a day | Total of all reporting groups | |
Overall Number of Baseline Participants | 49 | 94 | 143 | |
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[Not Specified]
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Age, Categorical
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 49 participants | 94 participants | 143 participants | |
<=18 years |
49 100.0%
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94 100.0%
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143.0 | |
Between 18 and 65 years |
0 0.0%
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0 0.0%
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0.0 | |
>=65 years |
0 0.0%
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0 0.0%
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0.0 | |
[1]
Measure Description: There were 147 children enrolled in the study (stated in the protocol). However, 4 children were randomized but did not receive a dose of the study drug. Therefore, only 143 received at least 1 dose of study drug.
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 49 participants | 94 participants | 143 participants | |
8.6 (3.1) | 8.9 (3.4) | 8.825 (3.313) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 49 participants | 94 participants | 143 participants | |
Female |
22 44.9%
|
49 52.1%
|
71.0 | |
Male |
27 55.1%
|
45 47.9%
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72.0 | |
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 49 participants | 94 participants | 143 participants |
Australia | 8 | 16 | 24 | |
Belgium | 1 | 1 | 2 | |
Chile | 4 | 9 | 13 | |
Czech Republic | 1 | 4 | 5 | |
Finland | 5 | 7 | 12 | |
Germany | 5 | 8 | 13 | |
Hungary | 2 | 2 | 4 | |
Italy | 1 | 2 | 3 | |
Poland | 5 | 9 | 14 | |
South Africa | 0 | 1 | 1 | |
Spain | 1 | 1 | 2 | |
United Kingdom | 9 | 21 | 30 | |
United States | 7 | 13 | 20 |
Outcome Measures
Adverse Events
Limitations and Caveats
The clinical meaningfulness of new fractures in the thoracic spine scored as Genant Grade I is unclear, thus the morphometric vertebral fracture data are evaluated further.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The findings of the study may be published in a scientific journal or presented at a scientific meeting. Before submitting the results of the study for publication or presentation, the Investigator will allow the Sponsor 30 days in which to review and comment on the manuscript.
Results Point of Contact
Name/Title: | Grexan Wulff, Manager Regulatory Affairs |
Organization: | Warner Chilcott |
Phone: | 973-442-3376 |
EMail: | gwulff@wcrx.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Warner Chilcott |
ClinicalTrials.gov Identifier: | NCT00106028 |
Other Study ID Numbers: |
2003100 HMR4003I/3001 |
First Submitted: | March 18, 2005 |
First Posted: | March 21, 2005 |
Results First Submitted: | April 15, 2009 |
Results First Posted: | June 28, 2010 |
Last Update Posted: | April 22, 2013 |