Trial · NCT00051636
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Who Achieve Therapeutic Response at 6 Months. | 6 months | Therapeutic response is defined as a reduction of at least 75% from baseline (Visit 1) in total serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase at the end of six months. |
| Secondary | Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28 | Baseline and day 28 | The percent change in serum alkaline phosphatase from baseline to day 28 was measured. |
| Secondary | Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10 | Baseline and day 10 | The percent change in serum C-telopeptide from baseline to day 10 was measured. |
| Secondary | Relative Change in Urine Alpha C-telopeptide (α-CTx) in ug/mmol at Day 10 | Baseline and day 10 | The percent change in urine alpha C-telopeptide from baseline to day 10 was measured. |
| Secondary | Time to First Therapeutic Response | 182 days | A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase. |
| Secondary | Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline | Baseline and day 28 | Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range. |
| Secondary | Change in Pain Severity Score | Baseline and day 182 | Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain. |
| Secondary | Change in Pain Interference Score | Baseline and day 182 | Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain. |
| Secondary | Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period | 8 years was the maximum | Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase. |
| Secondary | Number of Participants With a Partial Disease Relapse During the Extended Observation Period | 8 years was the maximum | Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase \>= 50% from the serum alkaline phosphatase measurement at month 6 and at least 1.25 times the upper normal limit. |
| Secondary | Number of Participants With a Disease Relapse During the Extended Observation Period | 8 years was the maximum | Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was \>= 80% of baseline serum alkaline phosphatase value. |
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.
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GET https://conductscience.org/api/trials/v1/NCT00051636/registered