Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen K. Winer, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001304
First received: November 3, 1999
Last updated: November 10, 2015
Last verified: November 2015

November 3, 1999
November 10, 2015
October 1991
March 2014   (final data collection date for primary outcome measure)
  • Serum Calcium Level [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 2.05-2.5. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.
  • Urine Calcium Excretion Level [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Measurements were taken1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/24 h, normal range 1.25-6.25. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.
Not Provided
Complete list of historical versions of study NCT00001304 on ClinicalTrials.gov Archive Site
  • Serum 1,25-hydroxyvitamin D Level [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = pg/ml. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.
  • Serum 25-hydroxyvitamin D Level [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = ng/ml. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.
  • Serum Magnesium Level [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 0.65-1.05. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.
  • Serum Phosphorus Level [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 0.7-1.4. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.
  • Urinary Creatinine Clearance [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = ml/min, normal range 90-125. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.
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Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34
Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34
This study has been important in establishing synthetic human parathyroid hormone 1-34 (PTH) as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with calcium and calcitriol. Providing synthetic human parathyroid hormone 1-34 (PTH) to patients who are unresponsive to conventional therapy has enabled severe cases of hypoparathyroidism to be managed effectively with the investigational drug, PTH. The primary goals of this study are to (1) provide long-term PTH therapy to patients who do not respond to conventional therapy; (2) understand the long-term effect of therapeutic PTH replacement on kidney function and bone mineral density; (3) study and track linear growth and bone accrual in children with hypoparathyroidism. (4) determine if subjects reach a normal level of peak bone mass and if the timing of this is comparable to normal age-matched healthy controls.
Vitamin D and its analogs, the conventional treatment for hypoparathyroidism, are associated with chronic hypercalciuria due to their lack of calcium-retaining effect in the kidney. This side effect usually occurs even while maintaining the serum calcium in the normal range and may lead to calcium deposition in the kidney (nephrocalcinosis) and renal insufficiency. This study examines the long-term effects of subcutaneous parathyroid hormone (PTH) therapy on calcium metabolism, bone, and renal function. Our previous short-term pilot study comparing subcutaneous PTH with calcitriol demonstrated a significant decrease in urinary calcium excretion during PTH therapy. Based upon these results, we hypothesized that treatment with PTH is more physiologic and provides improved long-term metabolic control. Additionally, treatment with PTH may avoid the adverse side effects on the kidney that are associated with conventional therapy. Patients initially come to the Clinical Center for a two week inpatient evaluation. Subsequent follow-up will occur semiannually on an outpatient basis.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypoparathyroidism
  • Drug: Synthetic Human Parathyroid Hormone 1-34
    twice daily subcutaneous injections
    Other Name: teriperitide
  • Drug: Calcitriol & Calcium
    Twice daily oral calcitriol with 1000 mg Calcium carbonate supplementation
    Other Name: rocaltrol; 1,25 OH Vitamin D
  • Experimental: PTH 1-34
    All patients received twice daily synthetic Human Parathyroid Hormone 1-34.
    Intervention: Drug: Synthetic Human Parathyroid Hormone 1-34
  • Experimental: Calcitriol & Calcium
    All patients received twice daily Calcitriol and Calcium 1000mg divided into four doses daily.
    Intervention: Drug: Calcitriol & Calcium

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
April 2014
March 2014   (final data collection date for primary outcome measure)
  • INCLUSION CRITERIA:

This study will include patients (ages 17-69) with biochemically confirmed hypoparathyroidism.

EXCLUSION CRITERIA

Women who are pregnant will be excluded.

Both
17 Years to 69 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001304
920011, 92-CH-0011
Yes
Not Provided
Not Provided
Karen K. Winer, M.D., National Institutes of Health Clinical Center (CC)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Karen K Winer, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health Clinical Center (CC)
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP