A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism
Trial · NCT02910466
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 6 | Baseline (402), Month 6 | Safety population consisted of all enrolled participants who received at least 1 dose of rhPTH(1-84) regardless of study (SHP634-402 or AAAE0544 \[NCT01199614\] core study). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. | Millimole per liter (mmol/L) | MEAN |
| PRIMARY | Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 12 | Baseline (402), Month 12 | Safety population consisted of all enrolled participants who received at least 1 dose of rhPTH(1-84) regardless of study (SHP634-402 or AAAE0544 \[NCT01199614\] core study). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. | mmol/L | MEAN |
| PRIMARY | Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 18 | Baseline (402), Month 18 | Safety population consisted of all enrolled participants who received at least 1 dose of rhPTH(1-84) regardless of study (SHP634-402 or AAAE0544 \[NCT01199614\] core study). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. | mmol/L | MEAN |
| PRIMARY | Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 24 | Baseline (402), Month 24 | Safety population consisted of all enrolled participants who received at least 1 dose of rhPTH(1-84) regardless of study (SHP634-402 or AAAE0544 \[NCT01199614\] core study). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. | mmol/L | MEAN |
| PRIMARY | Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 30 | Baseline (402), Month 30 | Safety population consisted of all enrolled participants who received at least 1 dose of rhPTH(1-84) regardless of study (SHP634-402 or AAAE0544 \[NCT01199614\] core study). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. | mmol/L | MEAN |
| PRIMARY | Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 36 | Baseline (402), Month 36 | Safety population consisted of all enrolled participants who received at least 1 dose of rhPTH(1-84) regardless of study (SHP634-402 or AAAE0544 \[NCT01199614\] core study). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. | mmol/L | MEAN |
| PRIMARY | Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at End of Treatment (EOT) (up to Month 36) | Baseline (402), EOT (up to Month 36) | Safety population consisted of all enrolled participants who received at least 1 dose of rhPTH(1-84) regardless of study (SHP634-402 or AAAE0544 \[NCT01199614\] core study). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Due to the FDA recall, no participant received rhPTH for more than 36 months in the study. | mmol/L | MEAN |
| SECONDARY | Percentage of Participants Who Achieved ACSC Concentrations Above, Below, or in the Range of 1.875 mmol/L (7.5 Milligram Per Deciliter [mg/dL]) to Upper Limit of Normal (ULN) at Month 6, 12, 18, 24, 30, 36 and EOT (up to Month 36) | At Month 6, 12, 18, 24, 30, 36 and EOT (up to Month 36) | Safety population: all enrolled participants who received at least 1 dose of rhPTH(1-84) regardless of study (SHP634-402 or AAAE0544 \[NCT01199614\] core study). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Due to the FDA recall, no participant received rhPTH for more than 36 months in the study. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline (402) in Urinary Calcium Excretion at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Baseline (402), At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Safety population: all enrolled participants who received at least 1 dose of rhPTH(1-84) regardless of study (SHP634-402 or AAAE0544 \[NCT01199614\] core study). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Due to the FDA recall, no participant received rhPTH for more than 36 months in the study. | Millimole per day (mmol/day) | MEAN |
| SECONDARY | Change From Baseline (402) in Concentration of Serum Phosphate Levels at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Baseline (402), At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Safety population: all enrolled participants who received at least 1 dose of rhPTH(1-84) regardless of study (SHP634-402 or AAAE0544 \[NCT01199614\] core study). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Due to the FDA recall, no participant received rhPTH for more than 36 months in the study. | mmol/L | MEAN |
| SECONDARY | Change From Baseline (402) in Calcium Supplement Doses and Elemental Calcium Based on Investigator-prescribed Data and Diary Data at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Baseline, At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Safety population: all enrolled participants who received at least 1 dose of rhPTH(1-84) regardless of study (SHP634-402 or AAAE0544 \[NCT01199614\] core study). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Due to the FDA recall, no participant received rhPTH for more than 36 months in the study. | milligram per day (mg/day) | MEAN |
| SECONDARY | Change From Baseline (402) in Active Vitamin D Supplement Dose Based on Investigator-prescribed Data and Diary Data at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Baseline (402), At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Safety population: all enrolled participants who received at least 1 dose of rhPTH(1-84) regardless of study (SHP634-402 or AAAE0544 \[NCT01199614\] core study). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Due to the FDA recall, no participant received rhPTH for more than 36 months in the study. | microgram per day (mcg/day) | MEAN |
| SECONDARY | Change From Baseline (402) in Hypoparathyroidism Symptoms Diary (HPT-SD) at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Baseline (402), At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Safety population: all enrolled participants who received at least 1 dose of rhPTH(1-84) regardless of study (SHP634-402 or AAAE0544 \[NCT01199614\] core study). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Due to the FDA recall, no participant received rhPTH for more than 36 months in the study. | Score on a Scale | MEAN |
| SECONDARY | Change From Baseline (402) in Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) Assessment at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Baseline (402), At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Safety population: all enrolled participants who received at least 1 dose of rhPTH(1-84) regardless of study (SHP634-402 or AAAE0544 \[NCT01199614\] core study). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Due to the FDA recall, no participant received rhPTH for more than 36 months in the study. | Score on a Scale | MEAN |
| SECONDARY | Change From Baseline (402) in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Total Score at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Baseline (402), At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Safety population: all enrolled participants who received at least 1 dose of rhPTH(1-84) regardless of study (SHP634-402 or AAAE0544 \[NCT01199614\] core study). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Due to the FDA recall, no participant received rhPTH for more than 36 months in the study. | Score on a Scale | MEAN |
| SECONDARY | Change From Baseline (402) in Hospital Anxiety and Depression Scale (HADS) at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Baseline (402), At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Safety population: all enrolled participants who received at least 1 dose of rhPTH(1-84) regardless of study (SHP634-402 or AAAE0544 \[NCT01199614\] core study). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Due to the FDA recall, no participant received rhPTH for more than 36 months in the study. | Score on a Scale | MEAN |
| SECONDARY | Change From Baseline (402) in Health-related Quality-of-life Measured With 36-item Short Form Health (SF-36) Survey at Month 12, 24, 36, and EOT (up to Month 36) | Baseline (402), At Month 12, 24, 36, and EOT (up to Month 36) | Safety population consisted of all enrolled participants who received at least 1 dose of rhPTH(1-84) regardless of study (SHP634-402 or AAAE0544 \[NCT01199614\] core study). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Due to the FDA recall, no participant received rhPTH for more than 36 months in the study. | Score on a Scale | MEAN |
| SECONDARY | Change From Baseline (402) in Concentration of Bone Turnover Markers at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Baseline (402), At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Safety population: all enrolled participants who received at least 1 dose of rhPTH(1-84) regardless of study (SHP634-402 or AAAE0544 \[NCT01199614\] core study). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Due to the FDA recall, no participant received rhPTH for more than 36 months in the study. | mcg/L | MEAN |
| SECONDARY | Change From Baseline (402) in Concentration of Bone Turnover Marker for Bone Specific Alkaline Phosphatase and Tartrate-resistant Acid Phosphatase-5b at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Baseline (402), At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Safety population: all enrolled participants who received at least 1 dose of rhPTH(1-84) regardless of study (SHP634-402 or AAAE0544 \[NCT01199614\] core study). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Due to the FDA recall, no participant received rhPTH for more than 36 months in the study. | Units per liter (U/L) | MEAN |
| SECONDARY | Change From Baseline (402) in Bone Architecture Evaluated Using Dual-energy X-ray Absorptiometry (DXA) for Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Baseline, At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) | Safety population: all enrolled participants who received at least 1 dose of rhPTH(1-84) regardless of study (SHP634-402 or AAAE0544 \[NCT01199614\] core study). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. Due to the FDA recall, no participant received rhPTH for more than 36 months in the study. | Grams 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.
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