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Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34

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ClinicalTrials.gov Identifier: NCT00001304
Recruitment Status : Completed
First Posted : November 4, 1999
Results First Posted : December 15, 2015
Last Update Posted : December 15, 2015
Sponsor:
Information provided by (Responsible Party):
Karen K. Winer, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypoparathyroidism
Interventions Drug: Synthetic Human Parathyroid Hormone 1-34
Drug: Calcitriol & Calcium
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Calcitriol and Calcium PTH 1-34
Hide Arm/Group Description Twice daily po calcitriol with calcium carbonate given 4 times daily PTH 1-34 given as 2 subcutaneous injections daily
Period Title: Overall Study
Started 13 14
Completed 13 14
Not Completed 0 0
Arm/Group Title Calcitriol and Calcium PTH 1-34 Total
Hide Arm/Group Description Twice daily po calcitriol with calcium carbonate given 4 times daily PTH 1-34 given as 2 subcutaneous injections daily Total of all reporting groups
Overall Number of Baseline Participants 13 14 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
<=18 years
1
   7.7%
2
  14.3%
3
  11.1%
Between 18 and 65 years
12
  92.3%
11
  78.6%
23
  85.2%
>=65 years
0
   0.0%
1
   7.1%
1
   3.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
Female
7
  53.8%
10
  71.4%
17
  63.0%
Male
6
  46.2%
4
  28.6%
10
  37.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
Hispanic or Latino
0
   0.0%
1
   7.1%
1
   3.7%
Not Hispanic or Latino
13
 100.0%
13
  92.9%
26
  96.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
13
 100.0%
13
  92.9%
26
  96.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   7.1%
1
   3.7%
1.Primary Outcome
Title Serum Calcium Level
Hide Description Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 2.05-2.5. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients on the study
Arm/Group Title Calcitriol and Calcium PTH 1-34
Hide Arm/Group Description:
Twice daily po calcitriol with calcium carbonate given 4 times daily
PTH 1-34 given as 2 subcutaneous injections daily
Overall Number of Participants Analyzed 13 14
Mean (Standard Deviation)
Unit of Measure: mmol/liter
2  (0.01) 1.92  (0.02)
2.Primary Outcome
Title Urine Calcium Excretion Level
Hide Description Measurements were taken1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/24 h, normal range 1.25-6.25. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients on the study
Arm/Group Title Calcitriol and Calcium PTH 1-34
Hide Arm/Group Description:
Twice daily po calcitriol with calcium carbonate given 4 times daily
PTH 1-34 given as 2 subcutaneous injections daily
Overall Number of Participants Analyzed 13 14
Mean (Standard Deviation)
Unit of Measure: mmol/24 h
8.2  (0.51) 5.8  (0.27)
3.Secondary Outcome
Title Serum 1,25-hydroxyvitamin D Level
Hide Description Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = pg/ml. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients on the study
Arm/Group Title Calcitriol and Calcium PTH 1-34
Hide Arm/Group Description:
Twice daily po calcitriol with calcium carbonate given 4 times daily
PTH 1-34 given as 2 subcutaneous injections daily
Overall Number of Participants Analyzed 13 14
Mean (Standard Deviation)
Unit of Measure: pg/ml
40  (5) 43  (5)
4.Secondary Outcome
Title Serum 25-hydroxyvitamin D Level
Hide Description Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = ng/ml. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients on the study
Arm/Group Title Calcitriol and Calcium PTH 1-34
Hide Arm/Group Description:
Twice daily po calcitriol with calcium carbonate given 4 times daily
PTH 1-34 given as 2 subcutaneous injections daily
Overall Number of Participants Analyzed 13 14
Mean (Standard Deviation)
Unit of Measure: ng/ml
31  (5) 28  (4)
5.Secondary Outcome
Title Serum Magnesium Level
Hide Description Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 0.65-1.05. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients on the study
Arm/Group Title Calcitriol and Calcium PTH 1-34
Hide Arm/Group Description:
Twice daily po calcitriol with calcium carbonate given 4 times daily
PTH 1-34 given as 2 subcutaneous injections daily
Overall Number of Participants Analyzed 13 14
Mean (Standard Deviation)
Unit of Measure: mmol/liter
0.75  (0.01) 0.73  (0.02)
6.Secondary Outcome
Title Serum Phosphorus Level
Hide Description Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 0.7-1.4. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients on the study
Arm/Group Title Calcitriol and Calcium PTH 1-34
Hide Arm/Group Description:
Twice daily po calcitriol with calcium carbonate given 4 times daily
PTH 1-34 given as 2 subcutaneous injections daily
Overall Number of Participants Analyzed 13 14
Mean (Standard Deviation)
Unit of Measure: mmol/liter
4.5  (0.05) 4.6  (0.08)
7.Secondary Outcome
Title Urinary Creatinine Clearance
Hide Description Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = ml/min, normal range 90-125. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients on the study
Arm/Group Title Calcitriol and Calcium PTH 1-34
Hide Arm/Group Description:
Twice daily po calcitriol with calcium carbonate given 4 times daily
PTH 1-34 given as 2 subcutaneous injections daily
Overall Number of Participants Analyzed 13 14
Mean (Standard Deviation)
Unit of Measure: ml/min
84  (13) 80  (10)
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PTH 1-34 Calcitriol & Calcium
Hide Arm/Group Description

All patients received twice daily synthetic Human Parathyroid Hormone 1-34.

PTH 1-34

All patients received twice daily Calcitriol and Calcium 1000mg divided into four doses daily.

Calcitriol & Calcium

All-Cause Mortality
PTH 1-34 Calcitriol & Calcium
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PTH 1-34 Calcitriol & Calcium
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PTH 1-34 Calcitriol & Calcium
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/13 (0.00%) 
Study reported here was the primary long-term study for adults with hypoparathyroidism. Subsequent studies included additional patients.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: WINER, Karen
Organization: National Institute of Child Health and Human Development
Phone: +1 301 435 6877
EMail: winerk@mail.nih.gov
Layout table for additonal information
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 )
First Submitted: November 3, 1999
First Posted: November 4, 1999
Results First Submitted: March 12, 2015
Results First Posted: December 15, 2015
Last Update Posted: December 15, 2015