Trial Outcomes & Findings for Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34 (NCT NCT00001304)

NCT ID: NCT00001304

Last Updated: 2015-12-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2015-12-15

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	13	14
Overall Study COMPLETED	13	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34

Baseline characteristics by cohort

Measure	Calcitriol and Calcium n=13 Participants Twice daily po calcitriol with calcium carbonate given 4 times daily	PTH 1-34 n=14 Participants PTH 1-34 given as 2 subcutaneous injections daily	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: All patients on the study

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.

Outcome measures

Measure	Calcitriol and Calcium n=13 Participants Twice daily po calcitriol with calcium carbonate given 4 times daily	PTH 1-34 n=14 Participants PTH 1-34 given as 2 subcutaneous injections daily
Serum Calcium Level	2 mmol/liter Standard Deviation 0.01	1.92 mmol/liter Standard Deviation 0.02

PRIMARY outcome

Timeframe: 3 years

Population: All patients on the study

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.

Outcome measures

Measure	Calcitriol and Calcium n=13 Participants Twice daily po calcitriol with calcium carbonate given 4 times daily	PTH 1-34 n=14 Participants PTH 1-34 given as 2 subcutaneous injections daily
Urine Calcium Excretion Level	8.2 mmol/24 h Standard Deviation 0.51	5.8 mmol/24 h Standard Deviation 0.27

SECONDARY outcome

Timeframe: 3 years

Population: All patients on the study

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.

Outcome measures

Measure	Calcitriol and Calcium n=13 Participants Twice daily po calcitriol with calcium carbonate given 4 times daily	PTH 1-34 n=14 Participants PTH 1-34 given as 2 subcutaneous injections daily
Serum 1,25-hydroxyvitamin D Level	40 pg/ml Standard Deviation 5	43 pg/ml Standard Deviation 5

SECONDARY outcome

Timeframe: 3 years

Population: All patients on the study

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.

Outcome measures

Measure	Calcitriol and Calcium n=13 Participants Twice daily po calcitriol with calcium carbonate given 4 times daily	PTH 1-34 n=14 Participants PTH 1-34 given as 2 subcutaneous injections daily
Serum 25-hydroxyvitamin D Level	31 ng/ml Standard Deviation 5	28 ng/ml Standard Deviation 4

SECONDARY outcome

Timeframe: 3 years

Population: All patients on the study

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.

Outcome measures

Measure	Calcitriol and Calcium n=13 Participants Twice daily po calcitriol with calcium carbonate given 4 times daily	PTH 1-34 n=14 Participants PTH 1-34 given as 2 subcutaneous injections daily
Serum Magnesium Level	0.75 mmol/liter Standard Deviation 0.01	0.73 mmol/liter Standard Deviation 0.02

SECONDARY outcome

Timeframe: 3 years

Population: All patients on the study

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.

Outcome measures

Measure	Calcitriol and Calcium n=13 Participants Twice daily po calcitriol with calcium carbonate given 4 times daily	PTH 1-34 n=14 Participants PTH 1-34 given as 2 subcutaneous injections daily
Serum Phosphorus Level	4.5 mmol/liter Standard Deviation 0.05	4.6 mmol/liter Standard Deviation 0.08

SECONDARY outcome

Timeframe: 3 years

Population: All patients on the study

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.

Outcome measures

Measure	Calcitriol and Calcium n=13 Participants Twice daily po calcitriol with calcium carbonate given 4 times daily	PTH 1-34 n=14 Participants PTH 1-34 given as 2 subcutaneous injections daily
Urinary Creatinine Clearance	84 ml/min Standard Deviation 13	80 ml/min Standard Deviation 10

Adverse Events

PTH 1-34

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Calcitriol & Calcium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

WINER, Karen

National Institute of Child Health and Human Development

Phone: +1 301 435 6877

Email: winerk@mail.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place