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Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen K. Winer, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001304
First received: November 3, 1999
Last updated: November 10, 2015
Last verified: November 2015
Results First Received: March 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypoparathyroidism
Interventions: Drug: Synthetic Human Parathyroid Hormone 1-34
Drug: Calcitriol & Calcium

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Calcitriol and Calcium Twice daily po calcitriol with calcium carbonate given 4 times daily
PTH 1-34 PTH 1-34 given as 2 subcutaneous injections daily

Participant Flow:   Overall Study
    Calcitriol and Calcium   PTH 1-34
STARTED   13   14 
COMPLETED   13   14 
NOT COMPLETED   0   0 



  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.
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Reporting Groups
  Description
Calcitriol and Calcium Twice daily po calcitriol with calcium carbonate given 4 times daily
PTH 1-34 PTH 1-34 given as 2 subcutaneous injections daily
Total Total of all reporting groups

Baseline Measures
   Calcitriol and Calcium   PTH 1-34   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   14   27 
Age 
[Units: Participants]
     
<=18 years   1   2   3 
Between 18 and 65 years   12   11   23 
>=65 years   0   1   1 
Gender 
[Units: Participants]
     
Female   7   10   17 
Male   6   4   10 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   0   1   1 
Not Hispanic or Latino   13   13   26 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   0   0 
White   13   13   26 
More than one race   0   0   0 
Unknown or Not Reported   0   1   1 


  Outcome Measures
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1.  Primary:   Serum Calcium Level   [ Time Frame: 3 years ]

2.  Primary:   Urine Calcium Excretion Level   [ Time Frame: 3 years ]

3.  Secondary:   Serum 1,25-hydroxyvitamin D Level   [ Time Frame: 3 years ]

4.  Secondary:   Serum 25-hydroxyvitamin D Level   [ Time Frame: 3 years ]

5.  Secondary:   Serum Magnesium Level   [ Time Frame: 3 years ]

6.  Secondary:   Serum Phosphorus Level   [ Time Frame: 3 years ]

7.  Secondary:   Urinary Creatinine Clearance   [ Time Frame: 3 years ]


  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
Study reported here was the primary long-term study for adults with hypoparathyroidism. Subsequent studies included additional patients.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: WINER, Karen
Organization: National Institute of Child Health and Human Development
phone: +1 301 435 6877
e-mail: winerk@mail.nih.gov


Publications:

Responsible Party: Karen K. Winer, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001304     History of Changes
Other Study ID Numbers: 920011
92-CH-0011 ( Other Grant/Funding Number: NIH Clinical Center_NICHD )
Study First Received: November 3, 1999
Results First Received: March 12, 2015
Last Updated: November 10, 2015
Health Authority: United States: Food and Drug Administration