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This study is a long-term, open-label study using NPSP558 for the treatment of adult patients with Hypoparathyroidism.
Patients with a history of Hypoparathyroidism will be enrolled to receive study drug for up to 80 months, which will be injected daily in either thigh. During that time they will be monitored for safety (specifically calcium levels in blood or urine). In addition, the patients' intake of Vitamin D and Calcium will be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPSP558 | Experimental | titration of 25, 50, 75 or 100 μg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPSP558 | Drug | All patients will inject NPSP558 individual titration of 25, 50, 75 or 100 μg SC QD into alternating thighs in the morning via a multidose injection pen device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) | 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. | From start of study drug administration up to follow-up (82 months) |
| Number of Responders With Calcium Source at 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. | Week 52 |
| Number of Responders With Calcium Source at End Of Treatment (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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Oral Calcium Supplementation at 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. | Baseline, Week 52 and EOT (up to 82 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advance Medical Research LLC | Lakewood | California | 90712 | United States | ||
| Mayo Clinic Jacksonville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36018496 | Derived | Ayodele O, Rejnmark L, Mu F, Lax A, Berman R, Swallow E, Gosmanova EO. Five-Year Estimated Glomerular Filtration Rate in Adults with Chronic Hypoparathyroidism Treated with rhPTH(1-84): A Retrospective Cohort Study. Adv Ther. 2022 Nov;39(11):5013-5024. doi: 10.1007/s12325-022-02292-1. Epub 2022 Aug 26. | |
| 35974422 | Derived |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
A total of 51 participants were enrolled and 49 participants received treatment out of them 37 participants completed the study.
The study was conducted at 12 study centers in the United States between 06 April 2011 (first participant first visit) and 08 June 2018 (last participant last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | rhPTH(1-84) | Participants received rhPTH (1-84) subcutaneous injection with a starting dose of 25 or 50 microgram (mcg) once daily with dose adjusted by the investigator with upwards in increments of 25 mcg up to 100 mcg daily, with the goal to achieve or maintain total serum calcium levels in the range of 8.0 to 9.0 milligrams per deciliter (mg/dL). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Original Protocol | Dec 30, 2010 |
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|
| EOT (up to 82 months) |
| Percent Change From Baseline in Oral Calcitriol Supplementation at 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. |
| Baseline, Week 52 and EOT (up to 82 months) |
| Percent Change From Baseline in Albumin Corrected Total Serum Calcium (ACSC) at 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. | Baseline, EOT (up to 82 months) |
| Change From Baseline in 24-Hour Urine Calcium Excretion Through 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. | Baseline, EOT (up to 82 months) |
| Change From Baseline in 24-hour Urine Calcium Excretion in Participants Who Used Calcium-Sparing Diuretics Through 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. | Baseline, EOT (up to 82 months) |
| Change From Baseline in Serum Calcium Concentration in Participants Who Used and Calcium Sparing Diuretics at 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. | Baseline, EOT (upto 82 months) |
| Change From Baseline in Serum Phosphate at Month 72 and 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. | Baseline, Month 72, EOT (upto 82 months) |
| Number of Participants Who Maintained a Calcium Phosphate Product in A Normal Range at EOT (Up to 82 Months) | The normal range of calcium phosphate product is defined as <= 4.441 millimoles square per liter square (mmol^2/L^2). | EOT (up to 82 months) |
| Change From Baseline in Bone Turnover Markers at EOT (Up to 82 Months) | Bone Turnover Markers such as bone specific alkaline phosphatase (BSAP), serum procollagen type 1 amino-terminal propeptide (P1NP) , osteocalcin were reported in particpiants. EOT was defined as the last determination of response or last available measurement during the treatment period. | Baseline, EOT (up to 82 months) |
| Change From Baseline in Serum Carboxy Terminal Telopeptide of Type I Collagen (s-CTx) Bone Turnover Marker at EOT (Up to 82 Months) | Change form baseline in bone turnover marker (s-CTx)was reported. EOT was defined as the last determination of response or last available measurement during the treatment period. | Baseline, EOT (up to 82 months) |
| Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months) | Change from baseline in BMD of lumbar spine (L1-L4), hip-total, hip-trochanter, hip-intertrochanter, hip-ward's triangle, hip-femoral neck, distal one third radius at Week 52 then every 12 months until EOT were assessed by dual-energy X-ray absorptiometry [DXA] and Z-score. EOT was defined as the last determination of response or last available measurement during the treatment period. | Baseline, Week 52 and EOT (up to 82 months) |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Michigan Bone & Mineral Clinic PC | Detroit | Michigan | 48236 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| University Physicians Group | Staten Island | New York | 10301 | United States |
| Physician East PA | Greenville | North Carolina | 27834 | United States |
| University of Cincinnati Bone Health and Osteoporosis Center | Cincinnati | Ohio | 45219 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Cetero Research DGD Research Inc. | San Antonio | Texas | 78229 | United States |
| The Vancouver Clinic | Vancouver | Washington | 98664 | United States |
| Rejnmark L, Ayodele O, Lax A, Mu F, Swallow E, Gosmanova EO. The risk of chronic kidney disease development in adult patients with chronic hypoparathyroidism treated with rhPTH(1-84): A retrospective cohort study. Clin Endocrinol (Oxf). 2023 Apr;98(4):496-504. doi: 10.1111/cen.14813. Epub 2022 Aug 28. |
| 35696069 | Derived | Ayodele O, Mu F, Berman R, Swallow E, Rejnmark L, Gosmanova EO, Kaul S. Lower Risk of Cardiovascular Events in Adult Patients with Chronic Hypoparathyroidism Treated with rhPTH(1-84): A Retrospective Cohort Study. Adv Ther. 2022 Aug;39(8):3845-3856. doi: 10.1007/s12325-022-02198-y. Epub 2022 Jun 11. |
| 32738041 | Derived | Chen KS, Gosmanova EO, Curhan GC, Ketteler M, Rubin M, Swallow E, Zhao J, Wang J, Sherry N, Krasner A, Bilezikian JP. Five-year Estimated Glomerular Filtration Rate in Patients With Hypoparathyroidism Treated With and Without rhPTH(1-84). J Clin Endocrinol Metab. 2020 Oct 1;105(10):e3557-65. doi: 10.1210/clinem/dgaa490. |
| 31369089 | Derived | Mannstadt M, Clarke BL, Bilezikian JP, Bone H, Denham D, Levine MA, Peacock M, Rothman J, Shoback DM, Warren ML, Watts NB, Lee HM, Sherry N, Vokes TJ. Safety and Efficacy of 5 Years of Treatment With Recombinant Human Parathyroid Hormone in Adults With Hypoparathyroidism. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5136-5147. doi: 10.1210/jc.2019-01010. |
| Treated |
|
| Started Extension Period |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population included all enrolled participants who received at least 1 dose of study drug and had post baseline safety data.
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| ID | Title | Description |
|---|---|---|
| BG000 | rhPTH (1-84) | Participants received rhPTH (1-84) subcutaneous injection with a starting dose of 25 or 50 microgram (mcg) once daily with dose adjusted by the investigator with upwards in increments of 25 mcg up to 100 mcg daily, with the goal to achieve or maintain total serum calcium levels in the range of 8.0 to 9.0 milligrams per deciliter (mg/dL). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) | 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. | Safety population included all enrolled participants who received at least 1 dose of study drug and had post baseline safety data. | Posted | Count of Participants | Participants | From start of study drug administration up to follow-up (82 months) |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Number of Responders With Calcium Source at 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. | 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. | Posted | Count of Participants | Participants | Week 52 |
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Responders With Calcium Source at End Of Treatment (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. | 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. | Posted | Count of Participants | Participants | EOT (up to 82 months) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Oral Calcium Supplementation at 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. | ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. | Posted | Mean | Standard Deviation | % change of oral calcium supplementation | Baseline, Week 52 and EOT (up to 82 months) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Oral Calcitriol Supplementation at 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. | ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. | Posted | Mean | Standard Deviation | %changeoforal calcitriol supplementation | Baseline, Week 52 and EOT (up to 82 months) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Albumin Corrected Total Serum Calcium (ACSC) at 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. | ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. | Posted | Mean | Standard Deviation | Percent change in ACSC | Baseline, EOT (up to 82 months) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 24-Hour Urine Calcium Excretion Through 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. | ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. | Posted | Mean | Standard Deviation | Millimoles per day (mmol/day) | Baseline, EOT (up to 82 months) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 24-hour Urine Calcium Excretion in Participants Who Used Calcium-Sparing Diuretics Through 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. | 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. | Posted | Mean | Standard Deviation | Millimoles per day (mmol/day) | Baseline, EOT (up to 82 months) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Calcium Concentration in Participants Who Used and Calcium Sparing Diuretics at 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. | 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. | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | Baseline, EOT (upto 82 months) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Phosphate at Month 72 and 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. | 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. | Posted | Mean | Standard Deviation | Millimoles per day (mmol/day) | Baseline, Month 72, EOT (upto 82 months) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Maintained a Calcium Phosphate Product in A Normal Range at EOT (Up to 82 Months) | The normal range of calcium phosphate product is defined as <= 4.441 millimoles square per liter square (mmol^2/L^2). | ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. | Posted | Number | Count of participants | EOT (up to 82 months) |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Bone Turnover Markers at EOT (Up to 82 Months) | Bone Turnover Markers such as bone specific alkaline phosphatase (BSAP), serum procollagen type 1 amino-terminal propeptide (P1NP) , osteocalcin were reported in particpiants. EOT was defined as the last determination of response or last available measurement during the treatment period. | 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. | Posted | Mean | Standard Deviation | Microgram per liter (μg/L) | Baseline, EOT (up to 82 months) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Carboxy Terminal Telopeptide of Type I Collagen (s-CTx) Bone Turnover Marker at EOT (Up to 82 Months) | Change form baseline in bone turnover marker (s-CTx)was reported. EOT was defined as the last determination of response or last available measurement during the treatment period. | 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. | Posted | Mean | Standard Deviation | Nanogram per liter (ng/L) | Baseline, EOT (up to 82 months) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months) | Change from baseline in BMD of lumbar spine (L1-L4), hip-total, hip-trochanter, hip-intertrochanter, hip-ward's triangle, hip-femoral neck, distal one third radius at Week 52 then every 12 months until EOT were assessed by dual-energy X-ray absorptiometry [DXA] and Z-score. EOT was defined as the last determination of response or last available measurement during the treatment period. | 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. | Posted | Mean | Standard Deviation | gram per square centimeter (g/cm^2) | Baseline, Week 52 and EOT (up to 82 months) |
|
|
From start of study drug administration up to follow-up (Up to 82 months)
Safety population included all participants who received at least one dose of study drug with any follow-up information and differ from the started population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | rhPTH(1-84) | Participants received rhPTH (1-84) subcutaneous injection with a starting dose of 25 or 50 microgram (mcg) once daily with dose adjusted by the investigator with upwards in increments of 25 mcg up to 100 mcg daily, with the goal to achieve or maintain total serum calcium levels in the range of 8.0 to 9.0 milligrams per deciliter (mg/dL). | 2 | 49 | 13 | 49 | 48 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Biliary adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| |
| Lung adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Urine calcium increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Vitamin D decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypercalciuria | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Tetany | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| Jul 3, 2019 |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Protocol Amendment 1 | Jun 29, 2011 | Jul 3, 2019 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Protocol Amendment 2 | Oct 5, 2011 | Jul 3, 2019 | Prot_002.pdf |
| Prot | Yes | No | No | Study Protocol: Protocol Amendment 3 | Mar 15, 2012 | Jul 3, 2019 | Prot_003.pdf |
| Prot | Yes | No | No | Study Protocol: Protocol Amendment 5 | May 3, 2016 | Jul 3, 2019 | Prot_004.pdf |
| Prot | Yes | No | No | Study Protocol: Protocol Amendment 6 | Oct 24, 2016 | Jul 3, 2019 | Prot_005.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 22, 2018 | Jul 3, 2019 | SAP_006.pdf |
| ID | Term |
|---|---|
| D007011 | Hypoparathyroidism |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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|---|---|
| Participants |
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| Participants |
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