Trial Outcomes & Findings for Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism (NCT NCT00743782)
NCT ID: NCT00743782
Last Updated: 2026-03-04
Results Overview
Mean fasting serum calcium level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
COMPLETED
PHASE2
21 participants
Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection
2026-03-04
Participant Flow
One participant withdrew prior to randomization
Participant milestones
| Measure |
PTH 1-34 Delivered Through Pump, Then Subcutaneous Injection
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours, followed by PTH 1-34 twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
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PTH 1-34 Subcutaneous Injection, Then Delivered Through Pump
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks, followed by PTH 1-34 titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
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Period 1
STARTED
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10
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10
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Period 1
COMPLETED
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10
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10
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Period 1
NOT COMPLETED
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0
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0
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Period 2
STARTED
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10
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10
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Period 2
COMPLETED
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10
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10
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Period 2
NOT COMPLETED
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism
Baseline characteristics by cohort
| Measure |
Overall Study Participants
n=20 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years were randomized to receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) either as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults, with pods containing drug changed every 72 hours, or PTH 1-34 twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks followed by subsequent intervention for 13 weeks.
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|---|---|
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Age, Customized
7-20 years
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12 Participants
n=41 Participants
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Age, Customized
>= 21 years
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8 Participants
n=41 Participants
|
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Sex: Female, Male
Female
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14 Participants
n=41 Participants
|
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Sex: Female, Male
Male
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6 Participants
n=41 Participants
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|
Ethnicity (NIH/OMB)
Hispanic or Latino
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4 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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16 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=41 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=41 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=41 Participants
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Race (NIH/OMB)
White
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16 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
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2 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
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Region of Enrollment
United States
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20 participants
n=41 Participants
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PRIMARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean fasting serum calcium level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Serum Calcium in Children and Young Adults
|
2.02 mmol/liter
Standard Error 0.053
|
1.88 mmol/liter
Standard Error 0.03
|
PRIMARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean fasting serum calcium level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Serum Calcium in Adults
|
2.078 mmol/liter
Standard Error 0.065
|
2.153 mmol/liter
Standard Error 0.042
|
PRIMARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean 24-hour urine calcium excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children and young adults.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Urine Calcium Excretion in Children and Young Adults
|
5.17 mmol/24h
Standard Error 1.10
|
6.67 mmol/24h
Standard Error 0.76
|
PRIMARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean 24-hour urine calcium excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Urine Calcium Excretion in Adults
|
3.981 mmol/24h
Standard Error 0.679
|
9.655 mmol/24h
Standard Error 1.045
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean fasting serum phosphorus level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
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|---|---|---|
|
Mean Serum Phosphorus in Children and Young Adults
|
1.78 mmol/liter
Standard Error 0.07
|
1.58 mmol/liter
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean fasting serum phosphorus level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Serum Phosphorus in Adults
|
1.401 mmol/liter
Standard Error 0.086
|
1.350 mmol/liter
Standard Error 0.050
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean 24-hour urine phosphorus excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children and young adults.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Urine Phosphorus Excretion in Children and Young Adults
|
1.10 mmol/24h
Standard Error 0.25
|
0.83 mmol/24h
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean 24-hour urine phosphorus excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
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|---|---|---|
|
Mean Urine Phosphorus Excretion in Adults
|
28.697 mmol/24h
Standard Error 3.023
|
31.792 mmol/24h
Standard Error 3.723
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean fasting serum magnesium level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Serum Magnesium in Children and Young Adults
|
0.74 mmol/liter
Standard Error 0.02
|
0.65 mmol/liter
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean fasting serum magnesium level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Serum Magnesium in Adults
|
0.855 mmol/liter
Standard Error 0.020
|
0.778 mmol/liter
Standard Error 0.017
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean 24-hour urine magnesium excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children and young adults.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Urine Magnesium Excretion in Children and Young Adults
|
6.06 mmol/24h
Standard Error 1.28
|
7.38 mmol/24h
Standard Error 1.33
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean 24-hour urine magnesium excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Urine Magnesium Excretion in Adults
|
4.007 mmol/24h
Standard Error 0.363
|
4.766 mmol/24h
Standard Error 0.748
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean fasting serum alkaline phosphatase level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Serum Alkaline Phosphatase in Children and Young Adults
|
147.93 U/liter
Standard Error 19.58
|
242.31 U/liter
Standard Error 44.54
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean fasting serum alkaline phosphatase level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Serum Alkaline Phosphatase in Adults
|
92.531 U/liter
Standard Error 12.242
|
109.191 U/liter
Standard Error 15.105
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean fasting serum bone-specific alkaline phosphatase level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Serum Bone-specific Alkaline Phosphatase in Children and Young Adults
|
51.68 MCG/L
Standard Error 8.90
|
81.64 MCG/L
Standard Error 16.56
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean fasting serum 1,25-hydroxyvitamin D3 level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Serum 1,25-hydroxyvitamin D3 in Children and Young Adults
|
75.21 pg/ml
Standard Error 7.78
|
55.63 pg/ml
Standard Error 5.07
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean fasting serum 1,25-hydroxyvitamin D3 level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Serum 1,25-hydroxyvitamin D3 in Adults
|
32 pg/ml
Standard Error 3.257
|
35.286 pg/ml
Standard Error 3.239
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean fasting serum 25-hydroxyvitamin D3 level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Serum 25-hydroxyvitamin D3 in Children and Young Adults
|
37.96 ng/ml
Standard Error 3.23
|
32.92 ng/ml
Standard Error 3.46
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean fasting serum 25-hydroxyvitamin D3 level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Serum 25-hydroxyvitamin D3 in Adults
|
34.5 ng/ml
Standard Error 2.909
|
32.143 ng/ml
Standard Error 3.612
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean 24-hour urine creatinine clearance excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children and young adults.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Urine Creatinine Clearance Excretion in Children and Young Adults
|
111.57 ml/min
Standard Error 13.91
|
106.63 ml/min
Standard Error 6.74
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean 24-hour urine creatinine clearance excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Urine Creatinine Clearance Excretion in Adults
|
106.938 ml/min
Standard Error 9.235
|
114.021 ml/min
Standard Error 10.736
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean fasting serum osteocalcin level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Serum Osteocalcin in Children and Young Adults
|
188.75 ng/mL
Standard Error 20.72
|
308.16 ng/mL
Standard Error 43.27
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean fasting serum osteocalcin level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Serum Osteocalcin in Adults
|
40.963 ng/mL
Standard Error 9.714
|
73.408 ng/mL
Standard Error 16.401
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean 24-hour urine N-terminal telopeptide of type 1 collagen excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children and young adults.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Urine N-terminal Telopeptide Level in Children and Young Adults
|
404.79 nmol/mmol
Standard Error 87.00
|
1116.75 nmol/mmol
Standard Error 323.91
|
SECONDARY outcome
Timeframe: Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injectionPopulation: Intent-to-treat (ITT) population
Mean 24-hour urine N-terminal telopeptide of type 1 collagen excretion at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=8 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Urine N-terminal Telopeptide Level in Adults
|
46.625 nmol/mmol
Standard Error 8.729
|
116.063 nmol/mmol
Standard Error 26.567
|
SECONDARY outcome
Timeframe: Day 1-3 of baseline initial inpatient evaluationPopulation: Intent-to-treat (ITT) population
Mean fasting serum calcium, phosphorus, and magnesium levels first three days of initial baseline inpatient admission. Participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=20 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Blood Mineral Levels - Calcium, Phosphorus, Magnesium
Serum Magnesium (Adults)
|
0.842 mmol/liter
Standard Error 0.034
|
—
|
|
Mean Blood Mineral Levels - Calcium, Phosphorus, Magnesium
Serum Calcium (Children and young adults)
|
1.967 mmol/liter
Standard Error 0.038
|
—
|
|
Mean Blood Mineral Levels - Calcium, Phosphorus, Magnesium
Serum Calcium (Adults)
|
2.144 mmol/liter
Standard Error 0.059
|
—
|
|
Mean Blood Mineral Levels - Calcium, Phosphorus, Magnesium
Serum Phosphorus (Children and young adults)
|
1.662 mmol/liter
Standard Error 0.096
|
—
|
|
Mean Blood Mineral Levels - Calcium, Phosphorus, Magnesium
Serum Phosphorus (Adults)
|
1.475 mmol/liter
Standard Error 0.042
|
—
|
|
Mean Blood Mineral Levels - Calcium, Phosphorus, Magnesium
Serum Magnesium (Children and young adults)
|
0.700 mmol/liter
Standard Error 0.019
|
—
|
SECONDARY outcome
Timeframe: Day 1-3 of baseline initial inpatient evaluationPopulation: Intent-to-treat (ITT) population
Mean 24-hour urine calcium, phosphorus, and magnesium excretion first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children and young adults.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=20 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Urine Mineral Excretion - Calcium, Phosphorus, Magnesium
Urine calcium excretion (Children and young adults)
|
7.176 mmol/24h
Standard Error 0.649
|
—
|
|
Mean Urine Mineral Excretion - Calcium, Phosphorus, Magnesium
Urine calcium excretion (Adults)
|
9.371 mmol/24h
Standard Error 1.323
|
—
|
|
Mean Urine Mineral Excretion - Calcium, Phosphorus, Magnesium
Urine phosphorus excretion (Children and young adults)
|
0.747 mmol/24h
Standard Error 0.070
|
—
|
|
Mean Urine Mineral Excretion - Calcium, Phosphorus, Magnesium
Urine phosphorus excretion (Adults)
|
26.41 mmol/24h
Standard Error 3.982
|
—
|
|
Mean Urine Mineral Excretion - Calcium, Phosphorus, Magnesium
Urine magnesium excretion (Children and young adults)
|
6.975 mmol/24h
Standard Error 1.212
|
—
|
|
Mean Urine Mineral Excretion - Calcium, Phosphorus, Magnesium
Urine magnesium excretion (Adults)
|
5.665 mmol/24h
Standard Error 0.386
|
—
|
SECONDARY outcome
Timeframe: Day 1-3 of baseline initial inpatient evaluationPopulation: Intent-to-treat (ITT) population
Mean fasting serum alkaline phosphatase level first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=20 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Serum Alkaline Phosphatase
Children and young adults
|
180.736 U/liter
Standard Error 28.050
|
—
|
|
Mean Serum Alkaline Phosphatase
Adults
|
60.729 U/liter
Standard Error 4.499
|
—
|
SECONDARY outcome
Timeframe: Day 1-3 of baseline initial inpatient evaluationPopulation: Intent-to-treat (ITT) population
Mean fasting serum bone specific alkaline phosphatase level first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=12 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Serum Bone Specific Alkaline Phosphatase in Children and Young Adults
|
66.838 MCG/L
Standard Error 13.594
|
—
|
SECONDARY outcome
Timeframe: Day 1-3 of baseline initial inpatient evaluationPopulation: Intent-to-treat (ITT) population
Mean fasting serum 1,25-hydroxyvitamin D3 level first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=20 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Serum 1,25-hydroxyvitamin D3
Children and young adults
|
56.083 pg/ml
Standard Error 6.605
|
—
|
|
Mean Serum 1,25-hydroxyvitamin D3
Adults
|
33.063 pg/ml
Standard Error 4.524
|
—
|
SECONDARY outcome
Timeframe: Day 1-3 of baseline initial inpatient evaluationPopulation: Intent-to-treat (ITT) population
Mean fasting serum 25-hydroxyvitamin D3 and osteocalcin levels first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=20 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Serum Bone Minerals - 25-hydroxyvitamin D3 and Osteocalcin
Osteocalcin (Adults)
|
15.992 ng/ml
Standard Error 4.0746
|
—
|
|
Mean Serum Bone Minerals - 25-hydroxyvitamin D3 and Osteocalcin
25-hydroxyvitamin D3 (Children and young adults)
|
40.5 ng/ml
Standard Error 4.391
|
—
|
|
Mean Serum Bone Minerals - 25-hydroxyvitamin D3 and Osteocalcin
25-hydroxyvitamin D3 (Adults)
|
33.436 ng/ml
Standard Error 4.669
|
—
|
|
Mean Serum Bone Minerals - 25-hydroxyvitamin D3 and Osteocalcin
Osteocalcin (Children and young adults)
|
274.356 ng/ml
Standard Error 50.009
|
—
|
SECONDARY outcome
Timeframe: Day 1-3 of baseline initial inpatient evaluationPopulation: Intent-to-treat (ITT) population
Mean 24-hour urine creatinine clearance excretion first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=20 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Urine Creatinine Clearance Excretion
Children and young adults
|
99.100 ml/min
Standard Error 10.760
|
—
|
|
Mean Urine Creatinine Clearance Excretion
Adults
|
109.625 ml/min
Standard Error 9.956
|
—
|
SECONDARY outcome
Timeframe: Day 1-3 of baseline initial inpatient evaluationPopulation: Intent-to-treat (ITT) population
Mean 24-hour urine N-terminal telopeptide of type 1 collagen excretion first 3 days of initial baseline inpatient admission. Participants were admitted for five to seven days and 24 hour urine sample was collected each day for three days. Mean value for the three days was calculated with values corrected for body surface area in children.
Outcome measures
| Measure |
PTH 1-34 Delivered Through Pump
n=20 Participants
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) as titrated infusion through an insulin pump based on body weight, at 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, receive synthetic human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
Mean Urine N-terminal Telopeptide Level
Children and young adults
|
520.830 NMOL/MMOL
Standard Error 109.473
|
—
|
|
Mean Urine N-terminal Telopeptide Level
Adults
|
16.976 NMOL/MMOL
Standard Error 3.006
|
—
|
Adverse Events
PTH 1-34 Delivered Through Pump
PTH 1-34 Subcutaneous Injection
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PTH 1-34 Delivered Through Pump
n=20 participants at risk
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, received Synthetic Human Parathyroid Hormone 1-34 (PTH 1-34) as a titrated infusion through an insulin pump based on body weight, at a mean rate of 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults for 13 weeks, with pods containing drug changed every 72 hours.
|
PTH 1-34 Subcutaneous Injection
n=20 participants at risk
Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, received Synthetic Human Parathyroid Hormone 1-34 (PTH 1-34) twice daily subcutaneous injection based on body weight, at a mean daily dose of 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults for 13 weeks.
|
|---|---|---|
|
General disorders
Catheter site extravasation
|
0.00%
0/20 • 28 weeks
|
5.0%
1/20 • 28 weeks
|
|
General disorders
Fatigue
|
0.00%
0/20 • 28 weeks
|
5.0%
1/20 • 28 weeks
|
|
General disorders
Hyperthermia
|
0.00%
0/20 • 28 weeks
|
5.0%
1/20 • 28 weeks
|
|
General disorders
Injection site erythema
|
0.00%
0/20 • 28 weeks
|
10.0%
2/20 • 28 weeks
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/20 • 28 weeks
|
5.0%
1/20 • 28 weeks
|
|
Injury, poisoning and procedural complications
Unintentional medical device removal
|
15.0%
3/20 • 28 weeks
|
0.00%
0/20 • 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20 • 28 weeks
|
5.0%
1/20 • 28 weeks
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/20 • 28 weeks
|
5.0%
1/20 • 28 weeks
|
Additional Information
Dr. Karen Winer, MD
National Institute of Child Health and Human Development
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place