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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
Name/Title: WINER, Karen
Organization: National Institute of Child Health and Human Development
Phone: +1 301 435 6877
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