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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004757-40 | EudraCT Number |
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This study is being conducted to characterize the effects of twice daily administration of rhPTH(1-84) on the way the body handles rhPTH(1-84) as well as its actions and safety and tolerability over the course of 24 hours as compared with the current once daily dosing regimen of marketed rhPTH(1-84) (marketed in the United States as Natpara® and in the EU as Natpar).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A/B or B/A | Experimental | Participants will be randomized to either receive 25 microgram (mcg) rhPTH(1-84) twice daily with no calcium for treatment period 1 and 100mcg rhPTH(1-84) once daily with no calcium for treatment period 2; or 100mcg rhPTH(1-84) once daily with no calcium for treatment period 1 and 25mcg rhPTH(1-84) BID with no calcium for treatment period 2 |
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| C/B or B/C | Experimental | Participants will be randomized to either receive 50mcg rhPTH(1-84) twice daily with no calcium for treatment period 1 and 100mcg rhPTH(1-84) once daily with no calcium for treatment period 2; or 100mcg rhPTH(1-84) once daily with no calcium for treatment period 1 and 50mcg rhPTH(1-84) twice daily with no calcium for treatment period 2 |
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| D/E or E/D | Experimental | Participants will be randomized to either receive 25mcg rhPTH(1-84) twice daily with calcium for treatment period 1 and 100mcg rhPTH(1-84) once daily with calcium for treatment period 2; or 100mcg rhPTH(1-84) once daily with calcium for treatment period 1 and 25mcg rhPTH(1-84) twice daily with calcium for treatment period 2 |
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| F/E or E/F | Experimental | Participants will be randomized to either receive 50mcg rhPTH(1-84) twice daily with calcium for treatment period 1 and 100mcg rhPTH(1-84) once daily with calcium for treatment period 2; or 100mcg rhPTH(1-84) once daily with calcium for treatment period 1 and 50mcg rhPTH(1-84) twice daily with calcium for treatment period 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 25mcg rhPTH(1-84) | Drug | Participants will receive rhPTH(1-84) as twice-daily regimen (12 hours apart) of two 25mcg doses without calcium in cohort 1 and with calcium in cohort 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Maximum Observed Concentration (Cmax) During a Dosing Interval (Tmax) of Baseline Adjusted rhPTH(1-84) | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. Tmax of baseline adjusted rhPTH(1-84) was reported. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose ; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose |
| Maximum Plasma Concentration (Cmax) of Baseline Adjusted rhPTH(1-84) | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. Cmax of baseline adjusted rhPTH(1-84) was reported. | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose |
| Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Baseline Adjusted rhPTH(1-84) | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUClast of baseline adjsuted plasma rhPTH(1-84) was reported. | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAE's) | An AE that occured during the study was considered a TEAE if it had a start date/time on or after the first dose of investigational product or if it had a start date before the date of the first dose of investigational product, but increased in severity on or after the date/time of the first dose of investigational product. Number of participants with TEAE's were reported. |
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Inclusion Criteria:
Exclusion Criteria:
5 . In male and female rats, parathyroid hormone caused an increase in the incidence of osteosarcoma (a malignant bone tumor). The occurrence of osteosarcoma was dependent on parathyroid hormone dose and treatment duration. This effect was observed at parathyroid hormone exposure levels ranging from 3 to 71 times the exposure levels in humans receiving a 100 mcg dose of rhPTH(1-84). Therefore, participant who are at increased baseline risk for osteosarcoma such as participant with Paget's disease of bone or unexplained elevations of alkaline phosphatase, pediatric and young adult participants with open epiphyses, participants with hereditary disorders predisposing to osteosarcoma or participant with a prior history of external beam or implant radiation therapy involving the skeleton are excluded.
6. Participants who have a known history of hypercalcemia during initiation of treatment with PTH, PTH analogues or fragments of PTH.
7. Participants who have a known history of hypocalcemia following abrupt withdrawal of treatment with PTH, PTH analogues or fragments of PTH.
8. Participant dependent on regular parenteral calcium infusions (example, calcium gluconate) to maintain calcium homeostasis within 3 months prior to enrollment, as determined by the investigator.
9. Use of the following medications prior to administration of investigational product within: 14 days- thiazide diuretics; 30 days - loop diuretics, lithium, systemic corticosteroids (medical judgment is required by the investigator. Primarily high doses of systemic corticosteroids [example, prednisone] should be excluded. Stable doses of hydrocortisone [example, as treatment for Addison's disease] may be acceptable); 3 months - calcitonin, cinacalcet hydrochloride, treatment with rhPTH(1-84) or N-terminal PTH or PTH-related peptide fragments or analogs; For females: changes in hormone replacement therapy within 3 months are excluded. Stable (>=3 months) hormone replacement therapy is acceptable; 6 months - fluoride tablets, oral bisphosphonates, methotrexate, growth hormone, digoxin, raloxifene or similar selective estrogen receptor modulators (SERMs); 12 months - intravenous bisphosphonates, drug or alcohol abuse, as determined by the investigator.
10. Presence of any clinically significant results from laboratory tests, vital signs assessments, or electrocardiograms (ECGs), as judged by the investigator.
11. Twelve-lead ECG values (average of triplicate readings) demonstrating QTc>450 millisecond (msec) (males) or >470 msec (females) at the Clinical Screening Visit and/or any time points up to and including predose of Day 1 (Period 1).
12. Any medical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for this study.
13. Positive test result for any of the following viral infections at the Clinical Screening Visit: Hepatitis B surface antigen; hepatitis C; human immunodeficiency virus (HIV) 14. Known significant bleeding diathesis that could preclude multiple venipunctures as determined by the investigator.
15. Participants who have donated a total of 100 mL to 499 mL of whole blood within 30 days prior to dosing, or participants who have donated a total of more than 499 mL of whole blood within 56 days prior to dosing.
16. A positive screen for drugs of abuse at the Clinical Screening Visit, and/or a positive screen for drugs of abuse and alcohol at check-in to the CRC at Treatment Period 1. Participants taking prescription medications that might be detected during the urine screen for drugs of abuse may be enrolled per the investigator's medical judgment.
17. History of a clinically significant illness during the 4 weeks prior to dosing (as determined by the investigator).
18. History of any clinically significant surgery or procedure within the past 8 weeks, as determined by the investigator.
19. History of an allergic response(s) to PTH or PTH analogs, or other clinically significant allergies, as determined by the investigator.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Clinical Research | North Hollywood | California | 91606 | United States | ||
| Indiana University |
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 34 participants were enrolled and 33 completed the study. The study consisted of two treatment periods (Treatment period I and II) with four cohorts. Cohort I included Sequence AB and BA. Cohort II included Sequence CB and BC. Cohort III included Sequence DE and ED, Cohort IV included Sequence FE and EF.
This study was conducted in North America and Europe between 04 March 2017 (first participant first visit) to 08 March 2019 (last participant last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort I: Treatment A / B | Participants received 25 microgram (mcg) rhPTH(1-84) twice daily (BID) with no calcium for treatment period 1 and 100 mcg rhPTH(1-84) once daily (QD) with no calcium for treatment period 2 in the morning on Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of greater than or equal to (>=) 5 days but less than or equal to (<=) 30 days between the administration of 25 mcg BID and 100 mcg QD rhPTH(1-84). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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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 | Jun 18, 2018 | Mar 6, 2020 |
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| 50mcg rhPTH(1-84) | Drug | Participants will receive rhPTH(1-84) as twice daily regimen (12 hours apart) of two 50mcg doses without calcium in cohort 2 and with calcium in cohort 4 |
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| 100mcg rhPTH(1-84) | Drug | Participants will receive rhPTH(1-84) as once-daily regimen of one 100 mcg dose without calcium in cohort 1 and 2 and with calcium in cohort 3 and 4 in the morning. |
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| Area Under the Curve Extrapolated to Infinity (AUCinf) of Baseline Adjusted rhPTH(1-84) | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUCinf of baseline adjusted rhPTH(1-84) was reported. | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose |
| Area Under the Concentration Curve From Time Zero to 24 Hours Post the First Dose (AUC0-24) of Baseline Adjusted rhPTH(1-84) | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUC0-24 of baseline adjusted rhPTH(1-84) was reported. | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24 hours post-dose |
| Area Under the Concentration Curve From Time Zero to 12 Hours Post the First Dose (AUC0-12) of Baseline Adjusted rhPTH(1-84) | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUC0-12 of baseline adjusted rhPTH(1-84) was reported. AUC(0-12) was planned, analyzed and reported only in participants who received BID treatment ( Treatment A, Treatment C, Treatment D, Treatment F). | BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours post-dose |
| Area Under the Concentration Curve From Time of the Second Dose to 12 Hours Post the Second Dose (AUC12-24) of Baseline Adjusted rhPTH(1-84) | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUC12-24 of baseline adjusted rhPTH(1-84) was reported. AUC(12-24) was planned, analyzed and reported only in participants who received BID treatment ( Treatment A, Treatment C, Treatment D, Treatment F). | BID: 12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24 hours post-dose |
| Terminal Half-Life (t1/2) of Baseline Adjusted rhPTH(1-84) | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. T1/2 of baseline adjusted rhPTH(1-84) was reported. | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose |
| Area Under the Concentration-Time Curve That is Above the Baseline, From Time 0 to 24 Hours (AUCabove) of Baseline-Adjusted Serum Calcium Concentrations on Day -1 | Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. AUCabove of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day -1 was reported. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Day -1 |
| Area Under the Concentration-Time Curve That is Below the Baseline, From Time 0 to 24 Hours (AUCbelow) of Baseline-Adjusted Serum Calcium Concentrations on Day -1 | Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. AUCbelow of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day -1 was reported. | Day -1 |
| Time to Maximum Effect (TEmax) of Baseline-Adjusted Serum Calcium Concentrations on Day -1 | Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. TEmax of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day -1 were reported. | Day -1 |
| Maximum Effect (Emax) of Baseline-Adjusted Serum Calcium Concentrations on Day -1 | Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. Emax of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day -1 were reported. | Day -1 |
| Area Under the Concentration-Time Curve That is Above the Baseline, From Time 0 to 24 Hours (AUCabove) of Baseline-Adjusted Serum Calcium Concentrations on Day 1/Day 2 | Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. AUCabove of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day 1/Day 2 were reported. | Day1- QD: Pre-dose up to 24 hours post dose, Day2- BID: Pre-dose up to 36 hours post dose |
| Area Under the Concentration-Time Curve That is Below the Baseline, From Time 0 to 24 Hours (AUCbelow) of Baseline-Adjusted Serum Calcium Concentrations on Day 1/Day 2 | Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. AUCbelow of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day 1/Day 2 was reported. | Day1- QD: Pre-dose up to 24 hours post dose, Day2- BID: Pre-dose up to 36 hours post dose |
| Time to Maximum Effect (TEmax) of Baseline-Adjusted Serum Calcium Concentrations on Day 1/Day 2 | Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. TEmax of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day 1/Day 2 were reported. | Day1- QD: Pre-dose up to 24 hours post dose, Day2- BID: Pre-dose up to 36 hours post dose |
| Maximum Effect (Emax) of Baseline-Adjusted Serum Calcium Concentrations on Day 1/Day 2 | Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. Emax of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day 1/Day 2 were reported. | Day1- QD: Pre-dose up to 24 hours post dose, Day2- BID: Pre-dose up to 36 hours post dose |
| Total Amount of Urinary Calcium Excretion to Total Relative Amount of Creatinine Over 24 Hours by Day -1 | Total amount of urinary calcium excretion to total relative amount of creatinine over 24 hours by Day -1 was reported. | Day -1 |
| Total Amount of Urinary Calcium Excretion to Total Relative Amount of Creatinine Over 24 Hours by Day 1/ Day 2 | Total amount of urinary calcium excretion to total relative amount of creatinine over 24 hours by Day 1/ Day 2 was reported. | Day 1- QD: Pre-dose up to 24 hours post dose, Day 2- BID: Pre-dose up to 24 hours post dose |
| Total Urinary Excretion of Calcium Over 24 Hours by Day -1 | Total urinary excretion of calcium over 24 Hours by Day -1 was reported. | Day -1 |
| Total Urinary Excretion of Calcium Over 24 Hours by Day 1/ Day 2 | Total urinary excretion of calcium over 24 hours by Day1/Day 2 was reported. | Day 1- QD: Pre-dose up to 24 hours post dose, Day 2- BID: Pre-dose up to 24 hours post dose |
| From signing of informed consent up to follow up (up to Day 182) |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| University Of Kentucky School of Medicine | Lexington | Kentucky | 40536-0298 | United States |
| Crescent City Clinical Research Center, LLC | Metairie | Louisiana | 70006 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Mayo Clinic - PPDS | Rochester | Minnesota | 55905 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Ohio State University Wexner Medical Center | Columbus | Ohio | 43201 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| New Orleans Center for Clinical Research (NOCCR) - Knoxville | Knoxville | Tennessee | 37920 | United States |
| CHU de Quebec-Universite Laval | Québec | G1V 4G2 | Canada |
| Aarhus Universitetshospital | Aarhus N | Central Jutland | 8200 | Denmark |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont | Szeged | Csongrád megye | 6720 | Hungary |
| Semmelweis Egyetem | Budapest | 1083 | Hungary |
| Pécsi Tudományegyetem | Pécs | 7624 | Hungary |
| FG001 | Cohort I: Treatment B / A | Participants received 100 mcg rhPTH(1-84) QD with no calcium for treatment period 1 and 25 mcg rhPTH(1-84) BID with no calcium for treatment period 2 in the morning on Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of 100 mcg QD and 25 mcg BID rhPTH(1-84). |
| FG002 | Cohort II: Treatment C / B | Participants received 50 mcg rhPTH(1-84) BID with no calcium for treatment period 1 and 100 mcg rhPTH(1-84) QD with no calcium for treatment period 2 in the morning on Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of 50 mcg BID and 100 mcg QD rhPTH(1-84). |
| FG003 | Cohort II: Treatment B / C | Participants received 100 mcg rhPTH(1-84) QD with no calcium for treatment period 1 and 50 mcg rhPTH(1-84) BID with no calcium for treatment period 2 in the morning on Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of 100 mcg QD and 50 mcg BID rhPTH(1-84). |
| FG004 | Cohort III: Treatment D / E | Participants received 25 mcg rhPTH(1-84) BID with calcium for treatment period 1 and 100 mcg rhPTH(1-84) QD with calcium for treatment period 2 in the morning on Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of 25 mcg BID and 100 mcg QD rhPTH(1-84). |
| FG005 | Cohort III: Treatment E / D | Participants received 100 mcg rhPTH(1-84) QD with calcium for treatment period 1 and 25 mcg rhPTH(1-84) BID with calcium for treatment period 2 in the morning on Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of 100 mcg QD and 25 mcg BID rhPTH(1-84). |
| FG006 | Cohort IV: Treatment F / E | Participants received 50 mcg rhPTH(1-84) BID with calcium for treatment period 1 and 100 mcg rhPTH(1-84) QD with calcium for treatment period 2 in the morning on Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of 50 mcg BID and 100 mcg QD rhPTH(1-84). |
| FG007 | Cohort IV: Treatment E / F | Participants received 100 mcg rhPTH(1-84) QD with calcium for treatment period 1 and 50 mcg rhPTH(1-84) BID with calcium for treatment period 2 in the morning on Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of 100 mcg QD and 50 mcg BID rhPTH(1-84). |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Period 2 |
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Safety analysis set included enrolled participants who had received at least 1 dose of rhPTH(1-84).
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort I: Treatment A/B or Treatment B/A | Participants received either 25 mcg rhPTH(1-84) BID with no calcium for treatment period 1 and 100 mcg rhPTH(1-84) QD with no calcium for treatment period 2; or 100 mcg rhPTH(1-84) QD with no calcium for treatment period 1 and 25 mcg rhPTH(1-84) BID with no calcium for treatment period 2 in the morning of Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of rhPTH(1-84) or the first administration of rhPTH(1-84) in each period for QD or BID dosing, respectively. |
| BG001 | Cohort II: Treatment C/B or Treatment B/C | Participants received either 50 mcg rhPTH(1-84) BID with no calcium for treatment period 1 and 100 mcg rhPTH(1-84) QD with no calcium for treatment period 2; or 100 mcg rhPTH(1-84) QD with no calcium for treatment period 1 and 50 mcg rhPTH(1-84) BID with no calcium for treatment period 2 in the morning of Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of rhPTH(1-84) or the first administration of rhPTH(1-84) in each period for QD or BID dosing, respectively. |
| BG002 | Cohort III: Treatment D/E or Treatment E/D | Participants received either 25 mcg rhPTH(1-84) BID with calcium for treatment period 1 and 100 mcg rhPTH(1-84) QD with calcium for treatment period 2; or 100 mcg rhPTH(1-84) QD with calcium for treatment period 1 and 25 mcg rhPTH(1-84) BID with calcium for treatment period 2 in the morning of Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of rhPTH(1-84) or the first administration of rhPTH(1-84) in each period for QD or BID dosing, respectively. |
| BG003 | Cohort IV: Treatment F/E or Treatment E/F | Participants receive either 50 mcg rhPTH(1-84) BID with calcium for treatment period 1 and 100 mcg rhPTH(1-84) QD with calcium for treatment period 2; or 100 mcg rhPTH(1-84) QD with calcium for treatment period 1 and 50 mcg rhPTH(1-84) BID with calcium for treatment period 2 in the morning of Day 1 of respective treatment periods. The 2 treatment periods were separated by a washout period of > or = 5 days but < or = 30 days between the administration of rhPTH(1-84) or the first administration of rhPTH(1-84) in each period for QD or BID dosing, respectively. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||
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| Primary | Time of Maximum Observed Concentration (Cmax) During a Dosing Interval (Tmax) of Baseline Adjusted rhPTH(1-84) | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. Tmax of baseline adjusted rhPTH(1-84) was reported. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Pharmacokinetic (PK) analysis set consisted of all enrolled participants who did not have major protocol violations that affected the validity of the PK results, received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable postdose PK concentration value available for 1 dose regimen. | Posted | Median | Full Range | hours | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose ; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose |
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| Primary | Maximum Plasma Concentration (Cmax) of Baseline Adjusted rhPTH(1-84) | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. Cmax of baseline adjusted rhPTH(1-84) was reported. | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | picogram per milliliter (pg/mL) | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose |
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| Primary | Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Baseline Adjusted rhPTH(1-84) | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUClast of baseline adjsuted plasma rhPTH(1-84) was reported. | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure and at specific category. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*picogram per milliliter (h*pg/mL) | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose |
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| Primary | Area Under the Curve Extrapolated to Infinity (AUCinf) of Baseline Adjusted rhPTH(1-84) | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUCinf of baseline adjusted rhPTH(1-84) was reported. | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure and at specific category. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose |
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| Primary | Area Under the Concentration Curve From Time Zero to 24 Hours Post the First Dose (AUC0-24) of Baseline Adjusted rhPTH(1-84) | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUC0-24 of baseline adjusted rhPTH(1-84) was reported. | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24 hours post-dose |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Area Under the Concentration Curve From Time Zero to 12 Hours Post the First Dose (AUC0-12) of Baseline Adjusted rhPTH(1-84) | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUC0-12 of baseline adjusted rhPTH(1-84) was reported. AUC(0-12) was planned, analyzed and reported only in participants who received BID treatment ( Treatment A, Treatment C, Treatment D, Treatment F). | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours post-dose |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Area Under the Concentration Curve From Time of the Second Dose to 12 Hours Post the Second Dose (AUC12-24) of Baseline Adjusted rhPTH(1-84) | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUC12-24 of baseline adjusted rhPTH(1-84) was reported. AUC(12-24) was planned, analyzed and reported only in participants who received BID treatment ( Treatment A, Treatment C, Treatment D, Treatment F). | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | BID: 12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24 hours post-dose |
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| Primary | Terminal Half-Life (t1/2) of Baseline Adjusted rhPTH(1-84) | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. T1/2 of baseline adjusted rhPTH(1-84) was reported. | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure and at specific category. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose |
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| Primary | Area Under the Concentration-Time Curve That is Above the Baseline, From Time 0 to 24 Hours (AUCabove) of Baseline-Adjusted Serum Calcium Concentrations on Day -1 | Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. AUCabove of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day -1 was reported. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Pharmacodynamic (PD) analysis set consisted of all enrolled participants who did not have major protocol violations that affected the validity of the PD results, received at least 1 dose of rhPTH(1 84) and had at least 1 evaluable post-dose PD value available for 1 dose regimen. | Posted | Mean | Standard Deviation | hour*millimoles per Liter (h*mmol/L) | Day -1 |
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| Primary | Area Under the Concentration-Time Curve That is Below the Baseline, From Time 0 to 24 Hours (AUCbelow) of Baseline-Adjusted Serum Calcium Concentrations on Day -1 | Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. AUCbelow of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day -1 was reported. | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | h*mmol/L | Day -1 |
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| Primary | Time to Maximum Effect (TEmax) of Baseline-Adjusted Serum Calcium Concentrations on Day -1 | Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. TEmax of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day -1 were reported. | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Median | Full Range | hours | Day -1 |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Maximum Effect (Emax) of Baseline-Adjusted Serum Calcium Concentrations on Day -1 | Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. Emax of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day -1 were reported. | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | millimoles/Liter (mmol/L) | Day -1 |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Area Under the Concentration-Time Curve That is Above the Baseline, From Time 0 to 24 Hours (AUCabove) of Baseline-Adjusted Serum Calcium Concentrations on Day 1/Day 2 | Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. AUCabove of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day 1/Day 2 were reported. | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | h*mmol/L | Day1- QD: Pre-dose up to 24 hours post dose, Day2- BID: Pre-dose up to 36 hours post dose |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Area Under the Concentration-Time Curve That is Below the Baseline, From Time 0 to 24 Hours (AUCbelow) of Baseline-Adjusted Serum Calcium Concentrations on Day 1/Day 2 | Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. AUCbelow of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day 1/Day 2 was reported. | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | h*mmol/L | Day1- QD: Pre-dose up to 24 hours post dose, Day2- BID: Pre-dose up to 36 hours post dose |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Time to Maximum Effect (TEmax) of Baseline-Adjusted Serum Calcium Concentrations on Day 1/Day 2 | Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. TEmax of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day 1/Day 2 were reported. | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Median | Full Range | hours | Day1- QD: Pre-dose up to 24 hours post dose, Day2- BID: Pre-dose up to 36 hours post dose |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Maximum Effect (Emax) of Baseline-Adjusted Serum Calcium Concentrations on Day 1/Day 2 | Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. Emax of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day 1/Day 2 were reported. | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmol/L | Day1- QD: Pre-dose up to 24 hours post dose, Day2- BID: Pre-dose up to 36 hours post dose |
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| Primary | Total Amount of Urinary Calcium Excretion to Total Relative Amount of Creatinine Over 24 Hours by Day -1 | Total amount of urinary calcium excretion to total relative amount of creatinine over 24 hours by Day -1 was reported. | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmol/mmol | Day -1 |
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| Primary | Total Amount of Urinary Calcium Excretion to Total Relative Amount of Creatinine Over 24 Hours by Day 1/ Day 2 | Total amount of urinary calcium excretion to total relative amount of creatinine over 24 hours by Day 1/ Day 2 was reported. | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | millimoles Per millimoles (mmol/mmol) | Day 1- QD: Pre-dose up to 24 hours post dose, Day 2- BID: Pre-dose up to 24 hours post dose |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Total Urinary Excretion of Calcium Over 24 Hours by Day -1 | Total urinary excretion of calcium over 24 Hours by Day -1 was reported. | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmol | Day -1 |
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| Primary | Total Urinary Excretion of Calcium Over 24 Hours by Day 1/ Day 2 | Total urinary excretion of calcium over 24 hours by Day1/Day 2 was reported. | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmol | Day 1- QD: Pre-dose up to 24 hours post dose, Day 2- BID: Pre-dose up to 24 hours post dose |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAE's) | An AE that occured during the study was considered a TEAE if it had a start date/time on or after the first dose of investigational product or if it had a start date before the date of the first dose of investigational product, but increased in severity on or after the date/time of the first dose of investigational product. Number of participants with TEAE's were reported. | Safety analysis set included enrolled participants who received at least 1 dose of rhPTH(1 84). | Posted | Count of Participants | Participants | From signing of informed consent up to follow up (up to Day 182) |
|
From signing of informed consent up to follow up (up to Day 182)
One participant during the washout out period following the 100 mcg QD dosing treatment period with calcium supplement in cohort III withdrew from the study and considered only in combined arm (Cohort III + IV).
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 | Cohort I: Treatment A | Participants received 25 mcg rhPTH(1-84) BID with no calcium in the morning on Day 1 of respective treatment period in cohort I. | 0 | 9 | 0 | 9 | 3 | 9 |
| EG001 | Cohort II: Treatment C | Participants received 50 mcg rhPTH(1-84) BID with no calcium in the morning on Day 1 of respective treatment period in Cohort II. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG002 | Cohort I+II: Treatment B | Participants received 100 mcg rhPTH(1-84) QD with no calcium in both cohort I and II in the morning on Day 1 of respective treatment period. | 0 | 17 | 0 | 17 | 4 | 17 |
| EG003 | Cohort III: Treatment D | Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG004 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. | 0 | 8 | 0 | 8 | 3 | 8 |
| EG005 | Cohort III + IV: Treatment E | Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period. | 0 | 17 | 0 | 17 | 7 | 17 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Faeces soft | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Medical device site ulcer | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.0 | 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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 16, 2019 | Mar 6, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007011 | Hypoparathyroidism |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants received 100 mcg rhPTH(1-84) QD with no calcium in both cohort I and II in the morning on Day 1 of respective treatment period.
| OG003 | Cohort III: Treatment D | Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III. |
| OG004 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. |
| OG005 | Cohort III + IV: Treatment E | Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period. |
|
|
| Cohort I+II: Treatment B |
Participants received 100 mcg rhPTH(1-84) QD with no calcium in both cohort I and II in the morning on Day 1 of respective treatment period. |
| OG003 | Cohort III: Treatment D | Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III. |
| OG004 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. |
| OG005 | Cohort III + IV: Treatment E | Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period. |
|
|
Participants received 100 mcg rhPTH(1-84) QD with no calcium in both cohort I and II in the morning on Day 1 of respective treatment period. |
| OG003 | Cohort III: Treatment D | Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III. |
| OG004 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. |
| OG005 | Cohort III + IV: Treatment E | Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period. |
|
|
Participants received 100 mcg rhPTH(1-84) QD with no calcium in both cohort I and II in the morning on Day 1 of respective treatment period. |
| OG003 | Cohort III: Treatment D | Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III. |
| OG004 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. |
| OG005 | Cohort III + IV: Treatment E | Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period. |
|
|
Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III.
| OG003 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. |
|
|
Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III. |
| OG003 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. |
|
|
Participants received 100 mcg rhPTH(1-84) QD with no calcium in both cohort I and II in the morning on Day 1 of respective treatment period.
| OG003 | Cohort III: Treatment D | Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III. |
| OG004 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. |
| OG005 | Cohort III + IV: Treatment E | Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period. |
|
|
Participants received 100 mcg rhPTH(1-84) QD with no calcium in both cohort I and II in the morning on Day 1 of respective treatment period. |
| OG003 | Cohort III: Treatment D | Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III. |
| OG004 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. |
| OG005 | Cohort III + IV: Treatment E | Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period. |
|
|
| OG003 | Cohort III: Treatment D | Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III. |
| OG004 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. |
| OG005 | Cohort III + IV: Treatment E | Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period. |
|
|
| Cohort III: Treatment D |
Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III. |
| OG004 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. |
| OG005 | Cohort III + IV: Treatment E | Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period. |
|
|
| Cohort III: Treatment D |
Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III. |
| OG004 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. |
| OG005 | Cohort III + IV: Treatment E | Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period. |
|
|
| OG003 | Cohort III: Treatment D | Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III. |
| OG004 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. |
| OG005 | Cohort III + IV: Treatment E | Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period. |
|
|
| OG003 | Cohort III: Treatment D | Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III. |
| OG004 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. |
| OG005 | Cohort III + IV: Treatment E | Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period. |
|
|
| OG003 | Cohort III: Treatment D | Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III. |
| OG004 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. |
| OG005 | Cohort III + IV: Treatment E | Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period. |
|
|
| OG003 | Cohort III: Treatment D | Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III. |
| OG004 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. |
| OG005 | Cohort III + IV: Treatment E | Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period. |
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Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III.
| OG004 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. |
| OG005 | Cohort III + IV: Treatment E | Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period. |
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Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III. |
| OG004 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. |
| OG005 | Cohort III + IV: Treatment E | Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period. |
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| OG004 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. |
| OG005 | Cohort III + IV: Treatment E | Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period. |
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Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III.
| OG004 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. |
| OG005 | Cohort III + IV: Treatment E | Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period. |
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| OG003 | Cohort III: Treatment D | Participants received 25 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort III. |
| OG004 | Cohort IV: Treatment F | Participants received 50 mcg rhPTH(1-84) BID with calcium in the morning on Day 1 of respective treatment period in Cohort IV. |
| OG005 | Cohort III + IV: Treatment E | Participants received 100 mcg rhPTH(1-84) QD with calcium in both cohort III and IV in the morning on Day 1 of respective treatment period. |
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