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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism

NCTNCT00743782 (opens ClinicalTrials.gov in a new tab)Other id080203Other id08-CH-0203
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
21 participants (actual)
Sponsor
National Institutes of Health Clinical Center (CC) · Nih
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
22 Aug 2008
Primary completion
7 Apr 2014
Completion
7 Apr 2014
First posted
29 Aug 2008 (estimated)
Last update posted
4 Mar 2026
Conditions
Hypoparathyroidism · Hypocalcemia · Autoimmune Polyendocrine Syndrome Type 1 · Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2008201020122014
  1. Ph 2

    Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism

    NCT00743782

    22 Aug 2008 to 7 Apr 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This randomized crossover study will evaluate the safety, efficacy, and pharmacodynamics of synthetic human PTH 1-34 (PTH) delivered by an insulin pump (omnipod) compared with twice- daily subcutaneous injections. We predict pump delivery of PTH will simultaneously normalize blood and urine mineral levels with minimal or no fluctuations throughout the day, thus resulting in a more physiologic pharmacodynamic profile because this method of delivery mimics normal parathyroid gland function. Furthermore, we hypothesize that pump therapy will require lower PTH doses and will normalize markers of bone turnover. We anticipate the improved metabolic control when PTH is delivered by pump will be evident both in adults with surgically induced hypoparathyroidism and in children with more severe forms of hypoparathyroidism where there is an unmet need for improved therapy.

Interventions

  • Synthetic Human Parathyroid Hormone 1-34 pumpDrug

Arms2

  • Active comparator

    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, received Synthetic Human Parathyroid Hormone 1-34 (PTH) delivered through an insulin pump. The first admission included measures of blood and urine minerals for dose titration. The initial PTH dose was 0.2 μg/kg/day. After inpatient and outpatient blood and urine monitoring, the final mean dose at 13 weeks was 0.32 mcg/kg/day for children and 0.17 mcg/kg/day for adults. At the conclusion of the initial three-month study period, patients crossed over to the opposite arm (PTH by pump vs injections) for the final 3 months with the identical monitoring protocol.

  • Active comparator

    PTH 1-34 subcutaneous injection, then delivered through pump

    Children with genetic forms of hypoparathyroidism and adults with postsurgical hypoparathyroidism receive synthetic human parathyroid hormone 1-34 (PTH) delivered by twice-daily subcutaneous injections. The initial PTH total daily dose of 0.5 μg/kg/day. After inpatient and outpatient blood and urine monitoring, the final mean dose at 13 weeks was 0.85 mcg/kg/day for children and 0.47 mcg/kg/day for adults. At the conclusion of the first three-month study period, patients crossed over to the opposite drug-delivery arm (PTH delivered by pump vs injections) and entered the second 3-month study period, with the identical monitoring protocol.

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Mean Serum Calcium in Children and Young Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  2. Mean Serum Calcium in Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  3. Mean Urine Calcium Excretion in Children and Young Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  4. Mean Urine Calcium Excretion in Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

Secondary outcomes(20)

  1. Mean Serum Phosphorus in Children and Young Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  2. Mean Serum Phosphorus in Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  3. Mean Urine Phosphorus Excretion in Children and Young Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  4. Mean Urine Phosphorus Excretion in Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  5. Mean Serum Magnesium in Children and Young Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  6. Mean Serum Magnesium in Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  7. Mean Urine Magnesium Excretion in Children and Young Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  8. Mean Urine Magnesium Excretion in Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  9. Mean Serum Alkaline Phosphatase in Children and Young Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  10. Mean Serum Alkaline Phosphatase in Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  11. Mean Serum Bone-specific Alkaline Phosphatase in Children and Young Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  12. Mean Serum 1,25-hydroxyvitamin D3 in Children and Young Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  13. Mean Serum 1,25-hydroxyvitamin D3 in Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  14. Mean Serum 25-hydroxyvitamin D3 in Children and Young Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  15. Mean Serum 25-hydroxyvitamin D3 in Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  16. Mean Urine Creatinine Clearance Excretion in Children and Young Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  17. Mean Urine Creatinine Clearance Excretion in Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  18. Mean Serum Osteocalcin in Children and Young Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  19. Mean Serum Osteocalcin in Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

  20. Mean Urine N-terminal Telopeptide Level in Children and Young Adults

    Time frame · Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

Mean Serum Calcium in Children and Young Adults

GroupValue (mmol/liter)Spread
PTH 1-34 Delivered Through Pump2.020.053
PTH 1-34 Subcutaneous Injection1.880.03
Primary outcomeMean· Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

Mean Serum Calcium in Adults

GroupValue (mmol/liter)Spread
PTH 1-34 Delivered Through Pump2.0780.065
PTH 1-34 Subcutaneous Injection2.1530.042
Primary outcomeMean· Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

Mean Urine Calcium Excretion in Children and Young Adults

GroupValue (mmol/24h)Spread
PTH 1-34 Delivered Through Pump5.171.10
PTH 1-34 Subcutaneous Injection6.670.76
Primary outcomeMean· Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

Mean Urine Calcium Excretion in Adults

GroupValue (mmol/24h)Spread
PTH 1-34 Delivered Through Pump3.9810.679
PTH 1-34 Subcutaneous Injection9.6551.045
Secondary and other outcome results(4)
Secondary outcomeMean· Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

Mean Serum Phosphorus in Children and Young Adults

GroupValue (mmol/liter)Spread
PTH 1-34 Delivered Through Pump1.780.07
PTH 1-34 Subcutaneous Injection1.580.07
Secondary outcomeMean· Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

Mean Serum Phosphorus in Adults

GroupValue (mmol/liter)Spread
PTH 1-34 Delivered Through Pump1.4010.086
PTH 1-34 Subcutaneous Injection1.3500.050
Secondary outcomeMean· Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

Mean Urine Phosphorus Excretion in Children and Young Adults

GroupValue (mmol/24h)Spread
PTH 1-34 Delivered Through Pump1.100.25
PTH 1-34 Subcutaneous Injection0.830.10
Secondary outcomeMean· Day 1-3 of inpatient evaluation at the conclusion of 13 weeks of PTH 1-34 delivered by pump or injection

Mean Urine Phosphorus Excretion in Adults

GroupValue (mmol/24h)Spread
PTH 1-34 Delivered Through Pump28.6973.023
PTH 1-34 Subcutaneous Injection31.7923.723

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PTH 1-34 Delivered Through PumpChildren 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.0 / 200 / 203 / 20
PTH 1-34 Subcutaneous InjectionChildren 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.0 / 200 / 204 / 20

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2014

9 results

Effects of pump versus twice-daily injection delivery of synthetic parathyroid hormone 1-34 in children with severe congenital hypoparathyroidism.

Winer et al. 2014The Journal of pediatricscited by 83

PMID 24948345PMC4174419DOI 10.1016/j.jpeds.2014.04.060PUB-24948345

Rights unknown9 results
Source linkSee results (9)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2012

Corrected

Synthetic human parathyroid hormone 1-34 replacement therapy: a randomized crossover trial comparing pump versus injections in the treatment of chronic hypoparathyroidism.

Winer et al. 2012The Journal of clinical endocrinology and metabolismcited by 137

PMID 22090268PMC3275355DOI 10.1210/jc.2011-1908PUB-22090268

Rights unknown
Source linkRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 7 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
* INCLUSION CRITERIA: This study will include up to 24 patients of both genders (ages 7-70) with biochemically confirmed chronic hypoparathyroidism of at least one year duration. We will recruit adults with post-surgical hypoparathyroidism and children with genetic forms of hypoparathyroidism including autoimmune polyendocrine syndrome type 1 (APS-1) or hypocalcemia due to an activating mutation of the calcium sensing receptor. EXCLUSION CRITERIA: Subjects who meet any of the following criteria are not eligible for study entry: * Presence of significant hepatic or kidney disease * Pregnancy * Patients who are calcium infusion dependent. * Seizure disorder requiring antiepileptic medications

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