Trial · NCT02910466
A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism
NCT02910466, Phase 4, Completed, Shire; results first posted 2021-07-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism. Trials, record NCT02910466. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02910466
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism
- NCT number
- NCT02910466
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 39 participants, actual
- Lead sponsor
- Shire
- Conditions
- Chronic Hypoparathyroidism, Hypoparathyroidism
- Interventions
- rhPTH(1-84)
- First posted
- 2016-09-22
- Last updated
- 2021-07-28
- Results first posted
- 2021-07-28
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 6 | Baseline (402), Month 6 | Baseline (402) was defined as the last available pre-dose value in SHP634-402. |
| Primary | Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 12 | Baseline (402), Month 12 | Baseline (402) was defined as the last available pre-dose value in SHP634-402. |
| Primary | Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 18 | Baseline (402), Month 18 | Baseline (402) was defined as the last available pre-dose value in SHP634-402. |
| Primary | Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 24 | Baseline (402), Month 24 | Baseline (402) was defined as the last available pre-dose value in SHP634-402. |
| Primary | Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 30 | Baseline (402), Month 30 | Baseline (402) was defined as the last available pre-dose value in SHP634-402. |
| Primary | Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 36 | Baseline (402), Month 36 | Baseline (402) was defined as the last available pre-dose value in SHP634-402. |
| 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) | Baseline (402) was defined as the last available pre-dose value in SHP634-402. EOT was defined as the last determination of response during the treatment period (from the date of first dose to the date of last dose + 1 day), was analyzed in addition to the scheduled visits. |
| 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) | EOT was defined as the last determination of response during the treatment period (from the date of first dose to the date of last dose + 1 day), was analyzed in addition to the scheduled visits. Albumin-corrected Serum Calcium (mmol/L) = Total Calcium (mmol/L) + 0.02 \* (40 gram per liter \[g/L\] - Albumin \[g/L\]). |
| 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) | Baseline (402) was defined as the last available pre-dose value in SHP634-402. EOT was defined as the last determination of response during the treatment period (from the date of first dose to the date of last dose + 1 day), was analyzed in addition to the scheduled visits. Here, '0' in the number analyzed field signifies that no participants were evaluable at specified time point. |
| 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) | Baseline (402) was defined as the last available pre-dose value in SHP634-402. EOT was defined as the last determination of response during the treatment period (from the date of first dose to the date of last dose + 1 day), was analyzed in addition to the scheduled visits. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group354
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 6 | rhPTH(1-84) | -0.005 | Standard Deviation 0.1546 | Millimole per liter (mmol/L) | |
| Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 12 | rhPTH(1-84) | 0.069 | Standard Deviation 0.1838 | mmol/L | |
| Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 18 | rhPTH(1-84) | 0.066 | Standard Deviation 0.2158 | mmol/L | |
| Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 24 | rhPTH(1-84) | 0.112 | Standard Deviation 0.2314 | mmol/L | |
| Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 30 | rhPTH(1-84) | 0.145 | Standard Deviation 0.2447 | mmol/L | |
| Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 36 | rhPTH(1-84) | 0.170 | Standard Deviation NA | mmol/L | |
| Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at End of Treatment (EOT) (up to Month 36) | rhPTH(1-84) | 0.135 | Standard Deviation 0.2260 | mmol/L | |
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) | rhPTH(1-84) | At Month 6: less than (<) 1.875 mmol/L | 20.8 | Percentage of participants | |
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) | rhPTH(1-84) | At Month 6: 1.875 mmol/L to ULN | 79.2 | Percentage of participants | |
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) | rhPTH(1-84) | At Month 6: >ULN | 0 | Percentage of participants |
1 to 10 of 354Source ClinicalTrials.gov
See all 354 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | rhPTH(1-84) | 39 | |
| Overall Study | Safety Set | rhPTH(1-84) | 39 | |
| Overall Study | Treated | rhPTH(1-84) | 36 | |
| Overall Study | COMPLETED | rhPTH(1-84) | 0 | |
| Overall Study | NOT COMPLETED | rhPTH(1-84) | 39 |
Source ClinicalTrials.gov
Adverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypothyroidism | Endocrine disorders | rhPTH(1-84) | 2 | 39 | 2 |
| other | Constipation | Gastrointestinal disorders | rhPTH(1-84) | 3 | 39 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | rhPTH(1-84) | 2 | 39 | 2 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | rhPTH(1-84) | 2 | 39 | 2 |
| other | Nausea | Gastrointestinal disorders | rhPTH(1-84) | 4 | 39 | 5 |
| other | Drug hypersensitivity | Immune system disorders | rhPTH(1-84) | 2 | 39 | 2 |
| other | Seasonal allergy | Immune system disorders | rhPTH(1-84) | 2 | 39 | 2 |
| other | Bronchitis | Infections and infestations | rhPTH(1-84) | 3 | 39 | 4 |
| other | Influenza | Infections and infestations | rhPTH(1-84) | 5 | 39 | 5 |
| other | Nasopharyngitis | Infections and infestations | rhPTH(1-84) | 2 | 39 | 2 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | rhPTH(1-84) | 0 | 39 |
| Total, other adverse events | rhPTH(1-84) | 34 | 39 |
| Total, serious adverse events | rhPTH(1-84) | 6 | 39 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02910466
GET https://conductscience.org/api/trials/v1/NCT02910466/registered?page=2