Trial · NCT01297309
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) | From start of study drug administration up to follow-up (82 months) | Safety population included all enrolled participants who received at least 1 dose of study drug and had post baseline safety data. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Responders With Calcium Source at Week 52 | Week 52 | ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Responders With Calcium Source at End Of Treatment (EOT) (Up to 82 Months) | EOT (up to 82 months) | ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline in Oral Calcium Supplementation at Week 52 and EOT (Up to 82 Months) | Baseline, Week 52 and EOT (up to 82 months) | ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. | % change of oral calcium supplementation | MEAN |
| SECONDARY | Percent Change From Baseline in Oral Calcitriol Supplementation at Week 52 and EOT (Up to 82 Months) | Baseline, Week 52 and EOT (up to 82 months) | ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. | %changeoforal calcitriol supplementation | MEAN |
| SECONDARY | Percent Change From Baseline in Albumin Corrected Total Serum Calcium (ACSC) at EOT (Up to 82 Months) | Baseline, EOT (up to 82 months) | ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. | Percent change in ACSC | MEAN |
| SECONDARY | Change From Baseline in 24-Hour Urine Calcium Excretion Through EOT (Up to 82 Months) | Baseline, EOT (up to 82 months) | ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. | Millimoles per day (mmol/day) | MEAN |
| SECONDARY | Change From Baseline in 24-hour Urine Calcium Excretion in Participants Who Used Calcium-Sparing Diuretics Through EOT (Up to 82 Months) | Baseline, EOT (up to 82 months) | ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Millimoles per day (mmol/day) | MEAN |
| SECONDARY | Change From Baseline in Serum Calcium Concentration in Participants Who Used and Calcium Sparing Diuretics at EOT (Upto 82 Months) | Baseline, EOT (upto 82 months) | ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Millimoles per liter (mmol/L) | MEAN |
| SECONDARY | Change From Baseline in Serum Phosphate at Month 72 and EOT (Upto 82 Months) | Baseline, Month 72, EOT (upto 82 months) | ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Millimoles per day (mmol/day) | MEAN |
| SECONDARY | Number of Participants Who Maintained a Calcium Phosphate Product in A Normal Range at EOT (Up to 82 Months) | EOT (up to 82 months) | ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. | Count of participants | NUMBER |
| SECONDARY | Change From Baseline in Bone Turnover Markers at EOT (Up to 82 Months) | Baseline, EOT (up to 82 months) | ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Microgram per liter (μg/L) | MEAN |
| SECONDARY | Change From Baseline in Serum Carboxy Terminal Telopeptide of Type I Collagen (s-CTx) Bone Turnover Marker at EOT (Up to 82 Months) | Baseline, EOT (up to 82 months) | ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Nanogram per liter (ng/L) | MEAN |
| SECONDARY | Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months) | Baseline, Week 52 and EOT (up to 82 months) | ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | gram per square centimeter (g/cm^2) | MEAN |
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/NCT01297309/outcomes