Trial · NCT00103740
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Who Had Therapeutic Response at 6 Months | Baseline, 6 months | Modified intent to treat population: all randomized patients with both baseline and at least one post-baseline serum alkaline phosphatase measurement. Missing values at 6 months were imputed using the last post-baseline measurement prior to 6 months. | participants | NUMBER |
| SECONDARY | Relative Change in Serum Alkaline Phosphatase in U/L at Day 28 | Baseline and 28 days | Intent-to-treat population: all randomized patients. Participants with observations at baseline and 28 days were included in this analysis. | percent change | MEAN |
| SECONDARY | Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10 | Baseline and day 10 | Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis. | percent change | MEAN |
| SECONDARY | Relative Change in Urine α-CTx in ug/mmol at Day 10 | Baseline and day 10 | Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis. | percent change | MEAN |
| SECONDARY | Time to First Therapeutic Response | 182 days | Intent-to-treat population: all randomized patients. | days | MEDIAN |
| SECONDARY | Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 | Day 28 | Intent-to-treat population: all randomized patients. Participants with observations at day 28 were included in this analysis. | participants | NUMBER |
| SECONDARY | Change in Pain Severity at Day 182 | Baseline and day 182 | Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis. | units on a scale | MEAN |
| SECONDARY | Change in Pain Interference at Day 182 | Baseline and day 182 | Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis. | units on a scale | MEAN |
| SECONDARY | Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period | 8 years was the maximum | Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period. | participants | NUMBER |
| SECONDARY | Number of Participants With a Partial Disease Relapse During the Extended Observation Period | 8 years was the maximum | Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period. | participants | NUMBER |
| SECONDARY | Number of Participants With a Disease Relapse During the Extended Observation Period | 8 years was maximum | Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period. | participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00103740/outcomes