Trial · NCT00106028
Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
NCT00106028, Phase 3, Completed, Warner Chilcott; results first posted 2010-06-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children. Trials, record NCT00106028. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00106028
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
- NCT number
- NCT00106028
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 143 participants, actual
- Lead sponsor
- Warner Chilcott
- Conditions
- Osteogenesis Imperfecta
- Interventions
- risedronate sodium (Actonel), Placebo
- First posted
- 2005-03-21
- Last updated
- 2013-04-22
- Results first posted
- 2010-06-28
- 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.
Source ClinicalTrials.gov
Registered outcomes44
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population | Baseline and Month 12 | Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader. Duplicate scans obtained at screening and Month 12. |
| Secondary | Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population | Baseline and Month 24 | Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader. |
| Secondary | Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population | Baseline and Month 36 | Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader. |
| Secondary | Percent Change From Baseline in Total Body BMD at Month 12, ITT Population | Baseline and Month 12 | Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA. |
| Secondary | Percent Change From Baseline in Total Body BMD at Month 24, ITT Population | Baseline and Month 24 | Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA. |
| Secondary | Percent Change From Baseline in Total Body BMD at Month 36, ITT Population | Baseline and Month 36 | Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA. |
| Secondary | Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population | Baseline and Month 12 | |
| Secondary | Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population | Baseline and Month 24 | |
| Secondary | Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population | Baseline and Month 36 | |
| Secondary | Percent Change From Baseline in Total Body BMC at Month 12, ITT Population | Baseline and Month 12 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 registered outcomesOutcomes44
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population | Baseline and Month 24 | ITT Population | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population | Baseline and Month 36 | ITT Population | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Body BMD at Month 12, ITT Population | Baseline and Month 12 | ITT Population. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Body BMD at Month 24, ITT Population | Baseline and Month 24 | ITT Population. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Body BMD at Month 36, ITT Population | Baseline and Month 36 | ITT Population. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population | Baseline and Month 12 | ITT Population | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population | Baseline and Month 24 | ITT Population | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population | Baseline and Month 36 | ITT Population | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Body BMC at Month 12, ITT Population | Baseline and Month 12 | ITT Population | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Body BMC at Month 24, ITT Population | Baseline and Month 24 | ITT Population | Percent Change | LEAST_SQUARES_MEAN |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 outcomesResults by group152
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population | Placebo Daily | 21.316 | 95% Confidence Interval 17.357 to 25.275 | Percent Change | |
| Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population | Risedronate Daily | 25.754 | 95% Confidence Interval 22.860 to 28.648 | Percent Change | |
| Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population | Placebo Daily | 33.216 | 95% Confidence Interval 28.191 to 38.241 | Percent Change | |
| Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population | Risedronate Daily | 34.753 | 95% Confidence Interval 31.076 to 38.429 | Percent Change | |
| Percent Change From Baseline in Total Body BMD at Month 12, ITT Population | Placebo Daily | 4.252 | 95% Confidence Interval 2.762 to 5.743 | Percent Change | |
| Percent Change From Baseline in Total Body BMD at Month 12, ITT Population | Risedronate Daily | 5.806 | 95% Confidence Interval 4.740 to 6.872 | Percent Change | |
| Percent Change From Baseline in Total Body BMD at Month 24, ITT Population | Placebo Daily | 9.716 | 95% Confidence Interval 7.897 to 11.535 | Percent Change | |
| Percent Change From Baseline in Total Body BMD at Month 24, ITT Population | Risedronate Daily | 10.214 | 95% Confidence Interval 8.899 to 11.528 | Percent Change | |
| Percent Change From Baseline in Total Body BMD at Month 36, ITT Population | Placebo Daily | 13.540 | 95% Confidence Interval 11.204 to 15.876 | Percent Change | |
| Percent Change From Baseline in Total Body BMD at Month 36, ITT Population | Risedronate Daily | 13.076 | 95% Confidence Interval 11.374 to 14.777 | Percent Change |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Daily | 49 | |
| Overall Study | STARTED | Risedronate Daily | 94 | |
| Overall Study | Month 12 Completed/Started Open Label | Placebo Daily | 49 | |
| Overall Study | Month 12 Completed/Started Open Label | Risedronate Daily | 87 | |
| Overall Study | COMPLETED | Placebo Daily | 43 | |
| Overall Study | COMPLETED | Risedronate Daily | 82 | |
| Overall Study | NOT COMPLETED | Placebo Daily | 6 | |
| Overall Study | NOT COMPLETED | Risedronate Daily | 12 |
Source ClinicalTrials.gov
Adverse events308
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Placebo Daily | 3 | 49 | 4 |
| other | Upper respiratory tract infection | Infections and infestations | Risedronate Daily | 8 | 94 | 13 |
| other | Upper respiratory tract infection | Infections and infestations | Years 2 & 3 Placebo-Risedronate | 4 | 49 | 7 |
| other | Upper respiratory tract infection | Infections and infestations | Years 2 & 3 Risedronate | 7 | 87 | 9 |
| other | Bronchitis | Infections and infestations | Placebo Daily | 3 | 49 | 7 |
| other | Bronchitis | Infections and infestations | Risedronate Daily | 7 | 94 | 13 |
| other | Bronchitis | Infections and infestations | Years 2 & 3 Placebo-Risedronate | 2 | 49 | 5 |
| other | Bronchitis | Infections and infestations | Years 2 & 3 Risedronate | 8 | 87 | 13 |
| other | Nasopharyngitis | Infections and infestations | Placebo Daily | 3 | 49 | 3 |
| other | Nasopharyngitis | Infections and infestations | Risedronate Daily | 7 | 94 | 8 |
1 to 10 of 308Source ClinicalTrials.gov
See all 308 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Daily | ||
| Total, all-cause mortality | Risedronate Daily | ||
| Total, all-cause mortality | Years 2 & 3 Placebo-Risedronate | ||
| Total, all-cause mortality | Years 2 & 3 Risedronate | ||
| Total, other adverse events | Placebo Daily | 47 | 49 |
| Total, other adverse events | Risedronate Daily | 86 | 94 |
| Total, other adverse events | Years 2 & 3 Placebo-Risedronate | 46 | 49 |
| Total, other adverse events | Years 2 & 3 Risedronate | 79 | 87 |
| Total, serious adverse events | Placebo Daily | 8 | 49 |
| Total, serious adverse events | Risedronate Daily | 11 | 94 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23927913 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00106028
GET https://conductscience.org/api/trials/v1/NCT00106028/registered?page=2