Trial · NCT01297309
A Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)
NCT01297309, Phase 3, Completed, Shire; results first posted 2019-08-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE). Trials, record NCT01297309. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01297309
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)
- NCT number
- NCT01297309
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 51 participants, actual
- Lead sponsor
- Shire
- Conditions
- Hypoparathyroidism
- Interventions
- NPSP558
- First posted
- 2011-02-16
- Last updated
- 2021-05-25
- Results first posted
- 2019-08-06
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | SAE is an adverse event (AE) that results in death, life threatening, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, hospitalization or prolongation of existing hospitalization, congenital anomaly or birth defect, important medical events that may not result in death, be life threatening, or require hospitalization. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical or medicinal product. Treatment emergent adverse events (TEAEs) were defined as AEs whose onset occurs, severity worsens or intensity increases after receiving the study medication of this study and \<= 30 days after last dose of study drug. |
| Primary | Number of Responders With Calcium Source at Week 52 | Week 52 | A responder was defined as a participant who met all of the following 3 criteria at each (1) a greater than (\>) 50% reduction from baseline or less than (\<) 500 milligram (mg) of daily calcium supplementation. (2) a \>50% reduction from baseline or \<0.25 microgram (mcg) of daily calcitriol supplementation. (3) an albumin-corrected total serum calcium concentration that was normalized or maintained compared to the baseline greater than or equal to (\>=) 1.875 millimoles per liter (mmol/L) and not exceeding the Upper Limit of Normal (ULN) values (2.15 to 2.55 mmol/L). End of Treatment (EOT) was defined as the last determination of response or last available measurement during the treatment period. Number of responders with calcium source for citrate and carbonate at week 52 was reported here. |
| Primary | Number of Responders With Calcium Source at End Of Treatment (EOT) (Up to 82 Months) | EOT (up to 82 months) | A responder was defined as a participant who met all of the following 3 criteria at each (1) a greater than (\>) 50% reduction from baseline or less than (\<) 500 milligram (mg) of daily calcium supplementation. (2) a \>50% reduction from baseline or \<0.25 microgram (mcg) of daily calcitriol supplementation. (3) an albumin-corrected total serum calcium concentration that was normalized or maintained compared to the baseline greater than or equal to (\>=) 1.875 millimoles per liter (mmol/L) and not exceeding the Upper Limit of Normal (ULN) values (2.15 to 2.55 mmol/L). End of Treatment (EOT) was defined as the last determination of response or last available measurement during the treatment period. Number of responders with calcium source for citrate and carbonate at EOT was reported here. |
| 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) | Percent change from baseline of oral calcium supplementation were reported. EOT was defined as the last determination of response or last available measurement during the treatment period. |
| 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) | Percent change from baseline of oral calcitriol supplementation were reported. EOT was defined as the last determination of response or last available measurement during the treatment period. |
| Secondary | Percent Change From Baseline in Albumin Corrected Total Serum Calcium (ACSC) at EOT (Up to 82 Months) | Baseline, EOT (up to 82 months) | Percent change in ACSC was reported. EOT was defined as the last determination of response or last available measurement during the treatment period. |
| Secondary | Change From Baseline in 24-Hour Urine Calcium Excretion Through EOT (Up to 82 Months) | Baseline, EOT (up to 82 months) | Change in 24 hour urine calcium excretion was reported. EOT was defined as the last determination of response or last available measurement during the treatment period. |
| 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) | Change from baseline in urinary calcium concentration in participants who used at least one calcium-sparing diuretics and participants who not used calcium-sparing diuretics were reported. EOT was defined as the last determination of response or last available measurement during the treatment period. |
| 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) | Change in serum calcium concentration of the number of participants who used at least one calcium-sparing diuretics and not used calcium sparing diuretics were reported. EOT was defined as the last determination of response or last available measurement during the treatment period. |
| Secondary | Change From Baseline in Serum Phosphate at Month 72 and EOT (Upto 82 Months) | Baseline, Month 72, EOT (upto 82 months) | Change of serum phosphate from baseline were reported. EOT was defined as the last determination of response or last available measurement during the treatment period. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) | rhPTH (1-84) | Number of participants with TESAE | 13 | Participants | |
| Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) | rhPTH (1-84) | Number of participants with TEAE | 48 | Participants | |
| Number of Responders With Calcium Source at Week 52 | rhPTH (1-84) | Citrate (Responder) | 7 | Participants | |
| Number of Responders With Calcium Source at Week 52 | rhPTH (1-84) | Carbonate (Responder) | 21 | Participants | |
| Number of Responders With Calcium Source at End Of Treatment (EOT) (Up to 82 Months) | rhPTH (1-84) | Citrate (Responder) | 7 | Participants | |
| Number of Responders With Calcium Source at End Of Treatment (EOT) (Up to 82 Months) | rhPTH (1-84) | Carbonate (Responder) | 20 | Participants | |
| Percent Change From Baseline in Oral Calcium Supplementation at Week 52 and EOT (Up to 82 Months) | rhPTH (1-84) | Percent change from baseline at Week 52 | -68.7 | Standard Deviation 34.07 | % change of oral calcium supplementation |
| Percent Change From Baseline in Oral Calcium Supplementation at Week 52 and EOT (Up to 82 Months) | rhPTH (1-84) | Percent change from baseline at EOT | -39.4 | Standard Deviation 107.23 | % change of oral calcium supplementation |
| Percent Change From Baseline in Oral Calcitriol Supplementation at Week 52 and EOT (Up to 82 Months) | rhPTH (1-84) | Percent change from baseline at Week 52 | -72.024 | Standard Deviation 44.6232 | %changeoforal calcitriol supplementation |
| Percent Change From Baseline in Oral Calcitriol Supplementation at Week 52 and EOT (Up to 82 Months) | rhPTH (1-84) | Percent change from baseline at EOT | -73.737 | Standard Deviation 39.3461 | %changeoforal calcitriol supplementation |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 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) | 51 | |
| Overall Study | Treated | rhPTH(1-84) | 49 | |
| Overall Study | Started Extension Period | rhPTH(1-84) | 46 | |
| Overall Study | COMPLETED | rhPTH(1-84) | 37 | |
| Overall Study | NOT COMPLETED | rhPTH(1-84) | 14 |
Source ClinicalTrials.gov
Adverse events100
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 | Anaemia | Blood and lymphatic system disorders | rhPTH(1-84) | 3 | 49 | 3 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | rhPTH(1-84) | 3 | 49 | 3 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | rhPTH(1-84) | 13 | 49 | 17 |
| other | Arthritis | Musculoskeletal and connective tissue disorders | rhPTH(1-84) | 4 | 49 | 6 |
| other | Back pain | Musculoskeletal and connective tissue disorders | rhPTH(1-84) | 10 | 49 | 15 |
| other | Bursitis | Musculoskeletal and connective tissue disorders | rhPTH(1-84) | 4 | 49 | 4 |
| other | Joint swelling | Musculoskeletal and connective tissue disorders | rhPTH(1-84) | 3 | 49 | 3 |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | rhPTH(1-84) | 19 | 49 | 42 |
| other | Musculoskeletal pain | Musculoskeletal and connective tissue disorders | rhPTH(1-84) | 3 | 49 | 5 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | rhPTH(1-84) | 6 | 49 | 10 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | rhPTH(1-84) | 2 | 49 |
| Total, other adverse events | rhPTH(1-84) | 48 | 49 |
| Total, serious adverse events | rhPTH(1-84) | 13 | 49 |
Source ClinicalTrials.gov
Papers5
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/NCT01297309
GET https://conductscience.org/api/trials/v1/NCT01297309/results?page=2