Trial · NCT00005901
Pamidronate to Treat Osteogenesis Imperfecta in Children
NCT00005901, Phase 3, Completed, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); results first posted 2016-03-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pamidronate to Treat Osteogenesis Imperfecta in Children. Trials, record NCT00005901. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00005901
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pamidronate to Treat Osteogenesis Imperfecta in Children
- NCT number
- NCT00005901
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 34 participants, actual
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Conditions
- Osteogenesis Imperfecta
- Interventions
- Pamidronate (Aredia)
- First posted
- 2000-06-07
- Last updated
- 2016-03-01
- Results first posted
- 2016-03-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Bone Mineral Density in Response to Pamidronate | Baseline vs. 12 months after first dose | Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status. |
| Primary | Change in Bone Mineral Density in Response to Pamidronate | Baseline vs. 18 months after first dose | Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status. |
| Primary | Change in Bone Mineral Density in Response to Pamidronate | Baseline vs. 24 months after first dose | Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status. |
| Primary | Change in Bone Mineral Density in Response to Pamidronate | Baseline vs. 30 months after first dose | Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status. |
| Primary | Change in Bone Mineral Density in Response to Pamidronate | Baseline vs. 36 months after first dose | Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status. |
| Primary | Change in Bone Mineral Density in Response to Pamidronate | Baseline vs. 6 months after first dose | Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Bone Mineral Density in Response to Pamidronate | Baseline vs. 12 months after first dose | All subjects received Pamidronate for 3 years. | Z-score | MEAN |
| PRIMARY | Change in Bone Mineral Density in Response to Pamidronate | Baseline vs. 18 months after first dose | All subjects received Pamidronate for 3 years. | Z-score | MEAN |
| PRIMARY | Change in Bone Mineral Density in Response to Pamidronate | Baseline vs. 24 months after first dose | All subjects received Pamidronate for 3 years. | Z-score | MEAN |
| PRIMARY | Change in Bone Mineral Density in Response to Pamidronate | Baseline vs. 30 months after first dose | All subjects received Pamidronate for 3 years. | Z-score | MEAN |
| PRIMARY | Change in Bone Mineral Density in Response to Pamidronate | Baseline vs. 36 months after first dose | All subjects received Pamidronate for 3 years. | Z-score | MEAN |
| PRIMARY | Change in Bone Mineral Density in Response to Pamidronate | Baseline vs. 6 months after first dose | All subjects received Pamidronate for 3 years. | Z-score | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Bone Mineral Density in Response to Pamidronate | Pamidronate Every 3 Months for 3 Years | -3.54 | Standard Deviation 1.51 | Z-score | |
| Change in Bone Mineral Density in Response to Pamidronate | Pamidronate Every 6 Months for 3 Years | -4.98 | Standard Deviation 1.16 | Z-score | |
| Change in Bone Mineral Density in Response to Pamidronate | Pamidronate Every 3 Months for 3 Years | -3.71 | Standard Deviation 1.4 | Z-score | |
| Change in Bone Mineral Density in Response to Pamidronate | Pamidronate Every 6 Months for 3 Years | -4.65 | Standard Deviation 1.06 | Z-score | |
| Change in Bone Mineral Density in Response to Pamidronate | Pamidronate Every 3 Months for 3 Years | -3.48 | Standard Deviation 1.31 | Z-score | |
| Change in Bone Mineral Density in Response to Pamidronate | Pamidronate Every 6 Months for 3 Years | -4.7 | Standard Deviation 1.37 | Z-score | |
| Change in Bone Mineral Density in Response to Pamidronate | Pamidronate Every 3 Months for 3 Years | -3.48 | Standard Deviation 1.09 | Z-score | |
| Change in Bone Mineral Density in Response to Pamidronate | Pamidronate Every 6 Months for 3 Years | -4.05 | Standard Deviation 1.28 | Z-score | |
| Change in Bone Mineral Density in Response to Pamidronate | Pamidronate Every 3 Months for 3 Years | -3.31 | Standard Deviation 1.22 | Z-score | |
| Change in Bone Mineral Density in Response to Pamidronate | Pamidronate Every 6 Months for 3 Years | -4.18 | Standard Deviation 1.67 | Z-score |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Active Comparator: 1 | 19 | |
| Overall Study | STARTED | Active Comparator: 2 | 15 | |
| Overall Study | COMPLETED | Active Comparator: 1 | 19 | |
| Overall Study | COMPLETED | Active Comparator: 2 | 15 | |
| Overall Study | NOT COMPLETED | Active Comparator: 1 | 0 | |
| Overall Study | NOT COMPLETED | Active Comparator: 2 | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | Hypertension | Vascular disorders | Active Comparator: 1 | 0 | 19 | |
| other | Hypertension | Vascular disorders | Active Comparator: 2 | 1 | 15 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active Comparator: 1 | ||
| Total, all-cause mortality | Active Comparator: 2 | ||
| Total, other adverse events | Active Comparator: 1 | 0 | 19 |
| Total, other adverse events | Active Comparator: 2 | 1 | 15 |
| Total, serious adverse events | Active Comparator: 1 | 0 | 19 |
| Total, serious adverse events | Active Comparator: 2 | 0 | 15 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Active Comparator: 1 vs Active Comparator: 2: serious adverse events |
Source Trial comparisons
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/NCT00005901
GET https://conductscience.org/api/trials/v1/NCT00005901/registered