Clinical Trial Results:
An Open-label Study Investigating the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism
Summary
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EudraCT number |
2017-003067-36 |
Trial protocol |
HU DK |
Global end of trial date |
14 Apr 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Apr 2021
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First version publication date |
30 Apr 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
SHP634-404
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03364738 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Shire
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Sponsor organisation address |
300 Shire Way, Lexington, United States, MA 02421
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Public contact |
Study Director, Shire, ClinicalTransparency@takeda.com
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Scientific contact |
Study Director, Shire, ClinicalTransparency@takeda.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 Apr 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
14 Apr 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Apr 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study was to evaluate the proportion of subjects who achieved total serum calcium (albumin corrected) values in the range of 7.5 mg/dL (1.875 mmol/L) – upper limit of normal (ULN) and to further characterize the safety of rhPTH(1-84) in adult subjects with hypoparathyroidism (HPT).
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Protection of trial subjects |
The study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki and in compliance with all applicable industry regulations, International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 (1996), European Union (EU) Directive 2001/20/EC, as well as all applicable national and local laws and regulations.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
26 Sep 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Canada: 5
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Country: Number of subjects enrolled |
Denmark: 2
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Country: Number of subjects enrolled |
Hungary: 9
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Country: Number of subjects enrolled |
United States: 6
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Worldwide total number of subjects |
22
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EEA total number of subjects |
11
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
19
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From 65 to 84 years |
3
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects with HPT who completed SHP634-101 (2015-004757-40) study were eligible and enrolled in this extension study which was conducted at 10 sites in the United States, Denmark, Hungary and Canada between 26 September 2018 (first participant first visit) and 14 April 2020 (last participant last visit). | ||||||||||||||
Pre-assignment
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Screening details |
A total of 22 subjects were enrolled and treated in the study, of which 14 subjects completed the study. | ||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||
Arms
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Arm title
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rhPTH(1-84) | ||||||||||||||
Arm description |
Subjects received recombinant human parathyroid hormone (rhPTH) (1-84) (Natpara) 50 microgram (mcg), injection, subcutaneously, once daily in the thigh (alternate thigh every day) up to 52 weeks (end of treatment [EOT])/ early termination (ET). Dose escalation was done up to 100 mcg in increments of 25 mcg no more frequently than every 2 to 4 weeks, with the goal of achieving or maintaining albumin-corrected serum calcium (ACSC) levels in the range of 2-2.25 millimoles per liter (mmol/L) (8-9 milligrams per deciliter [mg/dL]). Administered dose was maintained once a participant achieved a stable ACSC level of 2-2.25 mmol/L (8-9 mg/dL) and had minimized supplement (active vitamin D and calcium supplement) doses. If ACSC was greater than (>) 2.25 mmol/L (>9.0 mg/dL), a starting dose of 25 mcg was administered. | ||||||||||||||
Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
Human recombinant parathyroid Hormone
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Investigational medicinal product code |
SHP634
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Other name |
Natpara
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Pharmaceutical forms |
Powder and solvent for solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Subjects received rhPTH(1-84) 50 mcg, injection, subcutaneously, once daily in the thigh (alternate thigh every day) up to Week 52 (end of treatment [EOT]).
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Baseline characteristics reporting groups
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Reporting group title |
rhPTH(1-84)
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Reporting group description |
Subjects received recombinant human parathyroid hormone (rhPTH) (1-84) (Natpara) 50 microgram (mcg), injection, subcutaneously, once daily in the thigh (alternate thigh every day) up to 52 weeks (end of treatment [EOT])/ early termination (ET). Dose escalation was done up to 100 mcg in increments of 25 mcg no more frequently than every 2 to 4 weeks, with the goal of achieving or maintaining albumin-corrected serum calcium (ACSC) levels in the range of 2-2.25 millimoles per liter (mmol/L) (8-9 milligrams per deciliter [mg/dL]). Administered dose was maintained once a participant achieved a stable ACSC level of 2-2.25 mmol/L (8-9 mg/dL) and had minimized supplement (active vitamin D and calcium supplement) doses. If ACSC was greater than (>) 2.25 mmol/L (>9.0 mg/dL), a starting dose of 25 mcg was administered. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
rhPTH(1-84)
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Reporting group description |
Subjects received recombinant human parathyroid hormone (rhPTH) (1-84) (Natpara) 50 microgram (mcg), injection, subcutaneously, once daily in the thigh (alternate thigh every day) up to 52 weeks (end of treatment [EOT])/ early termination (ET). Dose escalation was done up to 100 mcg in increments of 25 mcg no more frequently than every 2 to 4 weeks, with the goal of achieving or maintaining albumin-corrected serum calcium (ACSC) levels in the range of 2-2.25 millimoles per liter (mmol/L) (8-9 milligrams per deciliter [mg/dL]). Administered dose was maintained once a participant achieved a stable ACSC level of 2-2.25 mmol/L (8-9 mg/dL) and had minimized supplement (active vitamin D and calcium supplement) doses. If ACSC was greater than (>) 2.25 mmol/L (>9.0 mg/dL), a starting dose of 25 mcg was administered. |
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End point title |
Percentage of Subjects who Achieved Total Albumin-corrected Serum Calcium (ACSC) Values Greater Than or Equal to (>=) to the Range of 7.5 mg/dL (1.875 mmol/L) and less Than or Equal to (<=) Upper Limit of Normal (ULN) at Week 24 [1] | ||||||
End point description |
Percentage of subjects who achieved ACSC values >= to range of 1.875 mmol/L and <= ULN at Week 24 was reported. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84). Here, “number of subjects analysed” were subjects who were evaluable for this end point.
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End point type |
Primary
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End point timeframe |
At Week 24
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analyzed for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects With Total ACSC Values >= to the Range of 7.5 mg/dL (1.875 mmol/L) and <=ULN at Week 52 (End-of-treatment [EOT]) [2] | ||||||||
End point description |
Percentage of subjects who achieved ACSC values >= to range of 1.875 mmol/L and <= ULN at Week 52 (EOT) was reported. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84).
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End point type |
Primary
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End point timeframe |
At Week 52 (EOT)
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analyzed for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs [3] | ||||||||||
End point description |
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, and is an important medical event. TEAEs were defined as AEs with a start date on or after the first dose of investigational product or a start date before the date of the first dose of investigational product that increased in severity or after the date of the first dose. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84).
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End point type |
Primary
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End point timeframe |
From start of study drug administration to end of study (Week 56)
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Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analyzed for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects With Clinically Significant Change in Clinical Laboratory Values [4] | ||||||
End point description |
Clinical laboratory assessment included hematology, serum chemistry, urine chemistry and urinalysis. The investigator will assess out-of-range clinical laboratory values for clinical significance, to indicate whether or not the values are clinically significant. Any changes in clinical laboratory results which were deemed clinically significant by the investigator was reported. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84).
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End point type |
Primary
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End point timeframe |
From start of study drug administration to end of study (Week 56)
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Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analyzed for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects With Clinically Significant Change in Vital Sign [5] | ||||||
End point description |
Vital sign parameters included: temperature, pulse rate, respiration rate, systolic and diastolic blood pressure. Any changes in vital signs which were deemed clinically significant by the investigator was reported. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84).
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End point type |
Primary
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End point timeframe |
From start of study drug administration to end of study (Week 56)
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Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analyzed for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects With Clinically Significant Change in Electrocardiogram (ECG) Parameters [6] | ||||||
End point description |
Twelve-lead ECGs was performed in triplicate with a minimum 2-minute gap between traces. The participant rested in the supine position for at least 5 minutes before collecting the ECG. Assessment of ECG parameters included: heart rate, RR interval, PR interval, QRS interval, QT interval, and QTc interval. Any change in ECG assessments which were deemed clinically significant by the investigator was reported. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84).
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End point type |
Primary
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End point timeframe |
From start of study drug administration to end of study (Week 56)
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Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analyzed for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects With Clinically Significant Change in Estimated Glomerular Filtration Rate (eGFR) Values [7] | ||||||
End point description |
Estimated glomerular filtration rate (eGFR) was calculated using the chronic kidney disease epidemiology (CDK-epi) formula. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84).
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End point type |
Primary
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End point timeframe |
From start of study drug administration to end of study (Week 56)
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Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analyzed for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects With Clinically Significant Change in Serum Creatinine Value [8] | ||||||
End point description |
eGFR was assessed by measuring serum creatinine. Serum creatinine level was obtained directly from laboratory results. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84).
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End point type |
Primary
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End point timeframe |
From start of study drug administration to end of study (Week 56)
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Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analyzed for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects With Positive Anti-Parathyroid Hormone Antibodies at Week 24 [9] | ||||||
End point description |
Number of participants with positive anti-parathyroid hormone antibodies at Week 24 was reported. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84). Here “number of subjects analysed” were subjects who were evaluable for this end point.
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End point type |
Primary
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End point timeframe |
Week 24
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Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analyzed for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects With Positive Anti-Parathyroid Hormone Antibodies at Week 52 (EOT) [10] | ||||||
End point description |
Number of subjects with positive anti-parathyroid hormone antibodies at Week 52 (EOT) was reported. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84). Here “number of subjects analysed” were subjects who were evaluable for this end point.
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End point type |
Primary
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End point timeframe |
Week 52 (EOT)
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Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analyzed for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Albumin Corrected Serum Calcium (ACSC) Concentration at Weeks 24 and 52 (EOT) | ||||||||||||
End point description |
Change from baseline in ACSC concentration at Weeks 24 and 52 (EOT) was reported. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84). Here “n” were subjects who were evaluable for the end point at given time points.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 24 and 52 (EOT)
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Serum Phosphate Concentration at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT) | ||||||||||||||||||||||
End point description |
Change from baseline in serum phosphate concentration at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT) was reported. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84). Here “n” were subjects who were evaluable for the end point at given time points.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT)
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No statistical analyses for this end point |
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End point title |
Change From Baseline in ACSC-phosphate Product at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT) | ||||||||||||||||||||||
End point description |
Change from baseline in ACSC-phosphate product at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT) was reported. Here "mmol^2/L^2" is abbreviated as millimoles square per liter square. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84). Here “n” were subjects who were evaluable for the end point at given time points.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT)
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No statistical analyses for this end point |
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End point title |
Change From Baseline in 24-hour Urine Calcium Excretion at Weeks 16, 32 and 52 (EOT) | ||||||||||||||
End point description |
Change from baseline in 24-hour urine calcium excretion at Weeks 16, 32 and 52 (EOT) was reported. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84). Here “number of subjects analysed” were subjects who were evaluable for this end point and “n” were subjects who were evaluable for the end point at given time points.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 16, 32 and 52 (EOT)
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No statistical analyses for this end point |
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End point title |
Percentage Change From Baseline in Prescribed Supplemental Oral Calcium Dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (End of Study [EOS]) | ||||||||||||||||||||||||
End point description |
Percentage change from baseline in prescribed supplemental oral calcium dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS) were reported. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84). Here “n” were subjects who were evaluable for the end point at given time points. Data for Week 56 was not collected as study was early terminated due to FDA recall of rhPTH(1-84) (Natpara). Here "99999" refers to data not available and we have added it as space-fillers.
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End point type |
Secondary
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End point timeframe |
Baseline and at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS)
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No statistical analyses for this end point |
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End point title |
Percentage Change From Baseline in Prescribed Supplemental Active Vitamin D Dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS) | ||||||||||||||||||||||||
End point description |
Percentage change from baseline in prescribed supplemental oral calcium dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS) were reported. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84). Here “number of subjects analysed” were subjects who were evaluable for this end point and “n” were subjects who were evaluable for the end point at given time points. Data for Week 56 was not collected as study was early terminated due to FDA recall of rhPTH(1-84) (Natpara). Here "99999" refers to data not available and we have added it as space-fillers.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS)
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No statistical analyses for this end point |
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End point title |
Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase at Weeks 8, 24 and 52 (EOT) | ||||||||||||||
End point description |
Percentage change from baseline in serum bone-specific alkaline phosphatase at Weeks 8, 24 and 52 (EOT) was reported. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84). Here “n” were subjects who were evaluable for the end point at given time points.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 8, 24 and 52 (EOT)
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No statistical analyses for this end point |
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End point title |
Percentage Change From Baseline in Serum Osteocalcin at Weeks 8, 24 and 52 (EOT) | ||||||||||||||
End point description |
Percentage change from baseline in serum osteocalcin at Weeks 8, 24 and 52 (EOT) was reported. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84). Here “n” were subjects who were evaluable for the end point at given time points.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 8, 24 and 52 (EOT)
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No statistical analyses for this end point |
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End point title |
Percentage Change From Baseline in Procollagen 1 N-Terminal Propeptide at Weeks 8, 24 and 52 (EOT) | ||||||||||||||
End point description |
Percentage change from baseline in procollagen 1 N-terminal propeptide at Weeks 8, 24 and 52 (EOT) was reported. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84). Here “n” were subjects who were evaluable for the end point at given time points.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 8, 24 and 52 (EOT)
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No statistical analyses for this end point |
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End point title |
Percentage Change From Baseline in Type I Collagen C-Telopeptides at Weeks 8, 24 and 52 (EOT) | ||||||||||||||
End point description |
Percentage change from baseline in type I collagen C-telopeptides at Week 8, 24 and 52 (EOT) was reported. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84). Here “n” were subjects who were evaluable for the end point at given time points.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 8, 24 and 52 (EOT)
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No statistical analyses for this end point |
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End point title |
Percentage Change From Baseline in Type I Collagen N-Telopeptides at Weeks 8, 24 and 52 (EOT) | ||||||||||||||
End point description |
Percentage change from baseline in type I collagen N-telopeptides at Week 8, 24 and 52 (EOT) was reported. Safety analysis population consisted of all subjects who had received at least 1 dose of rhPTH(1-84). Here “n” were subjects who were evaluable for the end point at given time points.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 8, 24 and 52 (EOT)
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
From start of screening up to end of study (Week 56)
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20.1
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Reporting groups
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Reporting group title |
rhPTH(1-84)
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Reporting group description |
Subjects received rhPTH(1-84) (Natpara) 50 mcg, injection, subcutaneously, once daily in the thigh (alternate thigh every day) up to 52 weeks (EOT/ET). Dose escalation was done up to 100 mcg in increments of 25 mcg no more frequently than every 2 to 4 weeks, with the goal of achieving or maintaining ACSC levels in the range of 2-2.25 mmol/L (8-9 mg/dL). Administered dose was maintained once a participant achieved a stable ACSC level of 2-2.25 mmol/L (8-9 mg/dL) and had minimized supplement (active vitamin D and calcium supplement) doses. If ACSC was >2.25 mmol/L (>9.0 mg/dL), a starting dose of 25 mcg was administered. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |