Trial Outcomes & Findings for A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary (NCT NCT01455181)
NCT ID: NCT01455181
Last Updated: 2021-06-11
Results Overview
A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.
COMPLETED
PHASE3
24 participants
24 Weeks
2021-06-11
Participant Flow
24 Subjects were enrolled between 8/2011 to 5/2012 at 3 Clinical sites in Hungary.
Subjects previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study, or enrolled in REPLACE and dropped out during optimization, but currently met inclusion/exclusion criteria for REPLACE.
Participant milestones
| Measure |
NPSP558
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50, 75, or 100 mcg subcutaneously daily.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary
Baseline characteristics by cohort
| Measure |
NPSP558
n=24 Participants
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50, 75, or 100 mcg subcutaneously daily.
|
|---|---|
|
Age, Customized
< 45 years
|
6 Participants
n=5 Participants
|
|
Age, Customized
45 to 64 years
|
17 Participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 WeeksA ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.
Outcome measures
| Measure |
NPSP558
n=24 Participants
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50, 75, or 100 mcg subcutaneously daily.
|
|---|---|
|
Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data.
|
75.0 percentage of participants
Interval 53.3 to 90.2
|
SECONDARY outcome
Timeframe: 24 WeeksOutcome measures
| Measure |
NPSP558
n=24 Participants
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50, 75, or 100 mcg subcutaneously daily.
|
|---|---|
|
Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit
Week 8
|
-96.70 percentage of change
Standard Deviation 7.865
|
|
Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit
Week 16
|
-96.18 percentage of change
Standard Deviation 11.521
|
|
Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit
Week 24
|
-97.92 percentage of change
Standard Deviation 10.206
|
|
Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit
Week 2
|
-47.08 percentage of change
Standard Deviation 31.566
|
|
Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit
Week 4
|
-80.38 percentage of change
Standard Deviation 16.688
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement.
Outcome measures
| Measure |
NPSP558
n=24 Participants
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50, 75, or 100 mcg subcutaneously daily.
|
|---|---|
|
Mean Percentage Changes From Baseline in Oral Calcium at Each Visit
Week 2
|
-8.3 percentage of change
Standard Deviation 36.20
|
|
Mean Percentage Changes From Baseline in Oral Calcium at Each Visit
Week 4
|
-46.4 percentage of change
Standard Deviation 35.57
|
|
Mean Percentage Changes From Baseline in Oral Calcium at Each Visit
Week 8
|
-71.5 percentage of change
Standard Deviation 33.14
|
|
Mean Percentage Changes From Baseline in Oral Calcium at Each Visit
Week 16
|
-71.7 percentage of change
Standard Deviation 38.60
|
|
Mean Percentage Changes From Baseline in Oral Calcium at Each Visit
Week 24
|
-76.0 percentage of change
Standard Deviation 40.48
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement .
A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.
Outcome measures
| Measure |
NPSP558
n=24 Participants
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50, 75, or 100 mcg subcutaneously daily.
|
|---|---|
|
Proportion of Patients Achieving the Primary Endpoint at Each Visit
Week 2
|
20.8 percentage of participants
|
|
Proportion of Patients Achieving the Primary Endpoint at Each Visit
Week 4
|
50.0 percentage of participants
|
|
Proportion of Patients Achieving the Primary Endpoint at Each Visit
Week 8
|
70.8 percentage of participants
|
|
Proportion of Patients Achieving the Primary Endpoint at Each Visit
Week 16
|
83.3 percentage of participants
|
|
Proportion of Patients Achieving the Primary Endpoint at Each Visit
Week 24
|
83.3 percentage of participants
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement.
Outcome measures
| Measure |
NPSP558
n=24 Participants
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50, 75, or 100 mcg subcutaneously daily.
|
|---|---|
|
Mean Change From Baseline in 24-hour Urine Calcium Excretion
Week 8
|
-64.58 mg/24 hour
Standard Deviation 188.42
|
|
Mean Change From Baseline in 24-hour Urine Calcium Excretion
Week 24
|
-51.53 mg/24 hour
Standard Deviation 183.41
|
Adverse Events
NPSP558
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NPSP558
n=24 participants at risk
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50, 75, or 100 mcg subcutaneously daily.
|
|---|---|
|
Nervous system disorders
Hypoaesthesia
|
50.0%
12/24 • Number of events 23 • 24 Weeks
|
|
Nervous system disorders
Headache
|
16.7%
4/24 • Number of events 5 • 24 Weeks
|
|
Nervous system disorders
Paraesthesia
|
8.3%
2/24 • Number of events 3 • 24 Weeks
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
20.8%
5/24 • Number of events 7 • 24 Weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
16.7%
4/24 • Number of events 4 • 24 Weeks
|
|
Metabolism and nutrition disorders
Tetany
|
12.5%
3/24 • Number of events 3 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
6/24 • Number of events 8 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
3/24 • Number of events 3 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
2/24 • Number of events 2 • 24 Weeks
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
12.5%
3/24 • Number of events 4 • 24 Weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
2/24 • Number of events 3 • 24 Weeks
|
|
Gastrointestinal disorders
Nausea
|
8.3%
2/24 • Number of events 2 • 24 Weeks
|
|
Investigations
Vitamin D decreased
|
25.0%
6/24 • Number of events 6 • 24 Weeks
|
|
General disorders
Fatigue
|
16.7%
4/24 • Number of events 6 • 24 Weeks
|
|
Renal and urinary disorders
Polyuria
|
8.3%
2/24 • Number of events 3 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
2/24 • Number of events 2 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
8.3%
2/24 • Number of events 3 • 24 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER