Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and vitamin D supplements.
Patients with a history of Hypoparathyroidism will be randomized to receive study drug for 8 weeks, 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25 µg dose | Experimental | 25 µg |
|
| 50 µg dose | Experimental | 50 µg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPSP558 | Drug | All patients will inject NPSP558 25 or 50 µg SC QD into alternating thighs in the morning via a multidose injection pen device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data. | The triple efficacy endpoint criteria were defined as a reduction from baseline in oral calcium to ≤ 500 mg/day, a reduction from baseline in calcitriol dose to ≤ 0.25 µg/day, and an albumin-corrected total serum calcium level between 7.5 mg/dL and the upper limit of the laboratory normal range. The analysis of primary endpoint was based on investigator prescribed data. | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8. | The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data |
Not provided
Main Inclusion Criteria:
Main Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advance Medical Research LLC | Lakewood | California | 90712 | United States | ||
| University of Chicago Medical Center |
| 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 |
Not provided
Not provided
Subjects who completed 24 wks of treatment and 4 wks follow-up in the REPLACE Study (NCT00732615) or received 2 single doses in Phase I Study C09-002 followed by a 4-wk washout, or enrolled in the REPLACE Study and entered into the optimization phase, but were not randomized due to the close of randomization; or were new to the NPSP558 program.
42 Subjects enrolled between 2/2011 and 9/2011 at 11 sites in the US.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | NPSP558 - 25 µg Dose | NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily. |
| FG001 | NPSP558 - 50 µg Dose | NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 8 Weeks |
| 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 |
| 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. |
| 28942334 | Derived | Bilezikian JP, Clarke BL, Mannstadt M, Rothman J, Vokes T, Lee HM, Krasner A. Safety and Efficacy of Recombinant Human Parathyroid Hormone in Adults With Hypoparathyroidism Randomly Assigned to Receive Fixed 25-mug or 50-mug Daily Doses. Clin Ther. 2017 Oct;39(10):2096-2102. doi: 10.1016/j.clinthera.2017.08.011. Epub 2017 Sep 21. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NPSP558 - 25 µg Dose | NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily |
| BG001 | NPSP558 - 50 µg Dose | NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | 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 | Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data. | The triple efficacy endpoint criteria were defined as a reduction from baseline in oral calcium to ≤ 500 mg/day, a reduction from baseline in calcitriol dose to ≤ 0.25 µg/day, and an albumin-corrected total serum calcium level between 7.5 mg/dL and the upper limit of the laboratory normal range. The analysis of primary endpoint was based on investigator prescribed data. | Intent to Treat (ITT) population, which includes all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | 8 Weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8. | The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data | Intent to Treat (ITT) population, which includes all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | 8 Weeks |
|
|
8 weeks
8 weeks on treatment
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 | NPSP558 - 25 µg Dose | NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily | 0 | 19 | 11 | 19 | ||
| EG001 | NPSP558 - 50 µg Dose | NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily | 0 | 23 | 17 | 23 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paresthesia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D007011 | Hypoparathyroidism |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| >/= 65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian/Pacific Islander |
|
| Superiority or Other (legacy) |
|
|
|