| Primary | Mean Serum Calcium in Children and Young Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | mmol/liter | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0002.02± 0.053
- OG0011.88± 0.03
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | t-test, 2 sided | | 0.02 | | | | | | | | | | | | | | Superiority | | |
|
| Primary | Mean Serum Calcium in Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | mmol/liter | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
| |
| Primary | Mean Urine Calcium Excretion in Children and Young Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | mmol/24h | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
| |
| Primary | Mean Urine Calcium Excretion in Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | mmol/24h | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
| |
| Secondary | Mean Serum Phosphorus in Children and Young Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | mmol/liter | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
| |
| Secondary | Mean Serum Phosphorus in Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | mmol/liter | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
| |
| Secondary | Mean Urine Phosphorus Excretion in Children and Young Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | mmol/24h | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
|
| Secondary | Mean Urine Phosphorus Excretion in Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | mmol/24h | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
| |
| Secondary | Mean Serum Magnesium in Children and Young Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | mmol/liter | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
| |
| Secondary | Mean Serum Magnesium in Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | mmol/liter | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
| |
| Secondary | Mean Urine Magnesium Excretion in Children and Young Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | mmol/24h | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
|
| Secondary | Mean Urine Magnesium Excretion in Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | mmol/24h | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
| |
| Secondary | Mean Serum Alkaline Phosphatase in Children and Young Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | U/liter | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Mean Serum Alkaline Phosphatase in Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | U/liter | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Mean Serum Bone-specific Alkaline Phosphatase in Children and Young Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | MCG/L | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
| |
| Secondary | Mean Serum 1,25-hydroxyvitamin D3 in Children and Young Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | pg/ml | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
| |
| Secondary | Mean Serum 1,25-hydroxyvitamin D3 in Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | pg/ml | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
| |
| Secondary | Mean Serum 25-hydroxyvitamin D3 in Children and Young Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | ng/ml | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
| |
| Secondary | Mean Serum 25-hydroxyvitamin D3 in Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | ng/ml | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
| |
| Secondary | Mean Urine Creatinine Clearance Excretion in Children and Young Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | ml/min | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
|
| Secondary | Mean Urine Creatinine Clearance Excretion in Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | ml/min | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
|---|
| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
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| Secondary | Mean Serum Osteocalcin in Children and Young Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | ng/mL | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
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| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
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| Secondary | Mean Serum Osteocalcin in Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | ng/mL | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
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| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
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| Secondary | Mean Urine N-terminal Telopeptide Level in Children and Young Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | nmol/mmol | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
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| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
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| Secondary | Mean Urine N-terminal Telopeptide Level in Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | nmol/mmol | | Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection | | | | ID | Title | Description |
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| OG000 | PTH 1-34 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) 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. | | OG001 | 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. |
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| Secondary | Mean Blood Mineral Levels - Calcium, Phosphorus, Magnesium | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | mmol/liter | | Day 1-3 of baseline initial inpatient evaluation | | | | ID | Title | Description |
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| OG000 | Baseline Evaluation | Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years will be admitted for an initial inpatient dose-adjustment phase lasting 5-7 days. After the initial evaluation consisting of history physical exam and laboratory panel, patients who meet recruitment criteria will be randomized to receive PTH 1-34 through an insulin pump or via subcutaneous injections. |
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| Secondary | Mean Urine Mineral Excretion - Calcium, Phosphorus, Magnesium | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | mmol/24h | | Day 1-3 of baseline initial inpatient evaluation | | | | ID | Title | Description |
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| OG000 | Baseline Evaluation | Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years will be admitted for an initial inpatient dose-adjustment phase lasting 5-7 days. After the initial evaluation consisting of history physical exam and laboratory panel, patients who meet recruitment criteria will be randomized to receive PTH 1-34 through an insulin pump or via subcutaneous injections. |
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| Secondary | Mean Serum Alkaline Phosphatase | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | U/liter | | Day 1-3 of baseline initial inpatient evaluation | | | | ID | Title | Description |
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| OG000 | Baseline Evaluation | Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years will be admitted for an initial inpatient dose-adjustment phase lasting 5-7 days. After the initial evaluation consisting of history physical exam and laboratory panel, patients who meet recruitment criteria will be randomized to receive PTH 1-34 through an insulin pump or via subcutaneous injections. |
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| Secondary | Mean Serum Bone Specific Alkaline Phosphatase in Children and Young Adults | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | MCG/L | | Day 1-3 of baseline initial inpatient evaluation | | | | ID | Title | Description |
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| OG000 | Baseline Evaluation | Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years will be admitted for an initial inpatient dose-adjustment phase lasting 5-7 days. After the initial evaluation consisting of history physical exam and laboratory panel, patients who meet recruitment criteria will be randomized to receive PTH 1-34 through an insulin pump or via subcutaneous injections. |
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| Secondary | Mean Serum 1,25-hydroxyvitamin D3 | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | pg/ml | | Day 1-3 of baseline initial inpatient evaluation | | | | ID | Title | Description |
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| OG000 | Baseline Evaluation | Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, will be admitted for an initial inpatient dose-adjustment phase lasting 5-7 days. After the initial evaluation consisting of history physical exam and laboratory panel, patients who meet recruitment criteria will be randomized to receive PTH 1-34 through an insulin pump or via subcutaneous injections. |
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| Secondary | Mean Serum Bone Minerals - 25-hydroxyvitamin D3 and Osteocalcin | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | ng/ml | | Day 1-3 of baseline initial inpatient evaluation | | | | ID | Title | Description |
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| OG000 | Baseline Evaluation | Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, will be admitted for an initial inpatient dose-adjustment phase lasting 5-7 days. After the initial evaluation consisting of history physical exam and laboratory panel, patients who meet recruitment criteria will be randomized to receive PTH 1-34 through an insulin pump or via subcutaneous injections. |
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| Secondary | Mean Urine Creatinine Clearance Excretion | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | ml/min | | Day 1-3 of baseline initial inpatient evaluation | | | | ID | Title | Description |
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| OG000 | Baseline Evaluation | Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, will be admitted for an initial inpatient dose-adjustment phase lasting 5-7 days. After the initial evaluation consisting of history physical exam and laboratory panel, patients who meet recruitment criteria will be randomized to receive PTH 1-34 through an insulin pump or via subcutaneous injections. |
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| Secondary | Mean Urine N-terminal Telopeptide Level | 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. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Error | NMOL/MMOL | | Day 1-3 of baseline initial inpatient evaluation | | | | ID | Title | Description |
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| OG000 | Baseline Evaluation | Children and young adults with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism, ages 7 to 70 years, will be admitted for an initial inpatient dose-adjustment phase lasting 5-7 days. After the initial evaluation consisting of history physical exam and laboratory panel, patients who meet recruitment criteria will be randomized to receive PTH 1-34 through an insulin pump or via subcutaneous injections. |
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