Trial · NCT03364738
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved Total Albumin-corrected Serum Calcium (ACSC) Values Greater Than or Equal to (>=) to the Range of 7.5 mg/dL (1.875 mmol/L) and Less Than or Equal to (<=) Upper Limit of Normal (ULN) at Week 24 | At Week 24 | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). Here overall number of participants analyzed were participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Total ACSC Values >= to the Range of 7.5 mg/dL (1.875 mmol/L) and <=ULN at Week 52 (End-of-treatment [EOT]) | At Week 52 (EOT) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). | percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | From start of study drug administration to end of study (Week 56) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Change in Clinical Laboratory Values | From start of study drug administration to end of study (Week 56) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Change in Vital Sign | From start of study drug administration to end of study (Week 56) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters | From start of study drug administration to end of study (Week 56) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Change in Estimated Glomerular Filtration Rate (eGFR) Values | From start of study drug administration to end of study (Week 56) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Change in Serum Creatinine Value | From start of study drug administration to end of study (Week 56) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Positive Anti-Parathyroid Hormone Antibodies at Week 24 | Week 24 | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). Here overall number of participants analyzed were participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Albumin Corrected Serum Calcium (ACSC) Concentration at Weeks 24 and 52 (EOT) | Baseline, Weeks 24 and 52 (EOT) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). Here number analyzed were participants who were evaluable for the outcome measure at given time points. | mmol/L | MEAN |
| SECONDARY | Change From Baseline in Serum Phosphate Concentration at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT) | Baseline, Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). Here number analyzed were participants who were evaluable for the outcome measure at given time points. | mmol/L | MEAN |
| SECONDARY | Change From Baseline in ACSC-phosphate Product at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT) | Baseline, Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). Here number analyzed were participants who were evaluable for the outcome measure at given time points. | mmol^2/L^2 | MEAN |
| SECONDARY | Change From Baseline in 24-hour Urine Calcium Excretion at Weeks 16, 32 and 52 (EOT) | Baseline, Weeks 16, 32 and 52 (EOT) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). Here overall number of participants analyzed were participants who were evaluable for this outcome measure and number analyzed were participants who were evaluable for the outcome measure at given time points. | millimoles per day (mmol/day) | MEAN |
| SECONDARY | Percentage Change From Baseline in Prescribed Supplemental Oral Calcium Dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (End of Study [EOS]) | Baseline and at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). Here number analyzed were participants who were evaluable for the outcome measure at given time points. Data for Week 56 was not collected as study was early terminated due to FDA recall of rhPTH(1-84) (Natpara). | percentage change | MEAN |
| SECONDARY | Percentage Change From Baseline in Prescribed Supplemental Active Vitamin D Dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS) | Baseline, Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). Here overall number of participants analyzed were participants who were evaluable for this outcome measure and number analyzed were participants who were evaluable for the outcome measure at given time points. Data for Week 56 was not collected as study was early terminated due to FDA recall of rhPTH(1-84) (Natpara). | percentage change | MEAN |
| SECONDARY | Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase at Weeks 8, 24 and 52 (EOT) | Baseline, Weeks 8, 24 and 52 (EOT) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). Here number analyzed were participants who were evaluable for the outcome measure at given time points. | percentage change | MEAN |
| SECONDARY | Percentage Change From Baseline in Serum Osteocalcin at Weeks 8, 24 and 52 (EOT) | Baseline, Weeks 8, 24 and 52 (EOT) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). Here number analyzed were participants who were evaluable for the outcome measure at given time points. | percentage change | MEAN |
| SECONDARY | Percentage Change From Baseline in Procollagen 1 N-Terminal Propeptide at Weeks 8, 24 and 52 (EOT) | Baseline, Weeks 8, 24 and 52 (EOT) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). Here number analyzed were participants who were evaluable for the outcome measure at given time points. | percentage change | MEDIAN |
| SECONDARY | Percentage Change From Baseline in Type I Collagen C-Telopeptides at Weeks 8, 24 and 52 (EOT) | Baseline, Weeks 8, 24 and 52 (EOT) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). Here number analyzed were participants who were evaluable for the outcome measure at given time points. | percentage change | MEAN |
| SECONDARY | Percentage Change From Baseline in Type I Collagen N-Telopeptides at Weeks 8, 24 and 52 (EOT) | Baseline, Weeks 8, 24 and 52 (EOT) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). Here number analyzed were participants who were evaluable for the outcome measure at given time points. | percentage change | 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.
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