Trial · NCT00103740
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 Had Therapeutic Response at 6 Months | Baseline, 6 months | A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase (SAP) excess (difference between measured level and midpoint to the normal range) or normalization of SAP at the end of six months. |
| Secondary | Relative Change in Serum Alkaline Phosphatase in U/L at Day 28 | Baseline and 28 days | 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 α-CTx in ug/mmol at Day 10 | Baseline and day 10 | The percent change in urine α-CTx from baseline to Day 10 was measured. |
| Secondary | Time to First Therapeutic Response | 182 days | Therapeutic response was defined as a reduction of at least 75% from baseline 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 | Day 28 | Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range. Central laboratory reference ranges for serum alkaline phosphatase: 31-110 U/L (female \& male 20-58 years) and 35-115 U/L (female \& male \>58 years). |
| Secondary | Change in Pain Severity at Day 182 | 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 at Day 182 | 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 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
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GET https://conductscience.org/api/trials/v1/NCT00103740/registered