Use of NPSP558 in the Treatment of Hypoparathyroidism (REPLACE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NPS Pharma
ClinicalTrials.gov Identifier:
NCT00732615
First received: August 8, 2008
Last updated: March 10, 2015
Last verified: March 2015
Results First Received: February 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypoparathyroidism
Interventions: Drug: Placebo
Drug: NPSP558

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
124 Subjects were enrolled between 12/2008 and 9/2011 at 28 clinical sites in North America, Western Europe and Hungary.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Subjects underwent a screening and stabilization period (optimization) of up to 16 weeks prior to enrollment.

Please note: Data for 10 subjects were excluded.


Reporting Groups
  Description
Placebo Matching Placebo: Placebo for subcutaneous injection
NPSP558 NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily

Participant Flow:   Overall Study
    Placebo     NPSP558  
STARTED     40     84  
COMPLETED     33     79  
NOT COMPLETED     7     5  
Withdrawal by Subject                 3                 1  
Lost to Follow-up                 0                 1  
Adverse Event                 0                 2  
Physician Decision                 3                 0  
Non-Compliance, Subject/Physician Dec.                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Matching Placebo: Placebo for subcutaneous injection
NPSP558 NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
Total Total of all reporting groups

Baseline Measures
    Placebo     NPSP558     Total  
Number of Participants  
[units: participants]
  40     84     124  
Age, Customized  
[units: participants]
     
< 45 years     13     35     48  
45 to 64 years     23     45     68  
> = 65 years     4     4     8  
Gender  
[units: participants]
     
Female     33     65     98  
Male     7     19     26  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     2     2  
Not Hispanic or Latino     40     82     122  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     1     2  
Native Hawaiian or Other Pacific Islander     0     1     1  
Black or African American     0     1     1  
White     39     80     119  
More than one race     0     0     0  
Unknown or Not Reported     0     1     1  
Region of Enrollment  
[units: participants]
     
North America     21     43     64  
Europe     12     25     37  
Hungary     7     16     23  



  Outcome Measures
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1.  Primary:   The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24.   [ Time Frame: Week 24 of dosing ]

2.  Secondary:   Percentage Changes From Baseline in Daily Calcium Dose at Week 24.   [ Time Frame: 24 Weeks ]

3.  Secondary:   Proportion of Subjects Who Achieved Independence From Active Vitamin D and an Oral Calcium Dose of ≤ 500 mg/Day at Week 24.   [ Time Frame: 24 Weeks ]

4.  Secondary:   Percentage of Subjects With Any Clinical Symptoms of Hypocalcemia During Weeks 16-24.   [ Time Frame: 8 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Executive Director, Clinical Development
Organization: NPS Pharmaceuticals
phone: +1 908-450-5300
e-mail: info@npsp.com


No publications provided


Responsible Party: NPS Pharma
ClinicalTrials.gov Identifier: NCT00732615     History of Changes
Other Study ID Numbers: CL1-11-040
Study First Received: August 8, 2008
Results First Received: February 20, 2015
Last Updated: March 10, 2015
Health Authority: United States: Food and Drug Administration