Trial · NCT00001304
Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34
NCT00001304, Phase 2, Completed, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); results first posted 2015-12-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34. Trials, record NCT00001304. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00001304
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34
- NCT number
- NCT00001304
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Conditions
- Hypoparathyroidism
- Interventions
- Synthetic Human Parathyroid Hormone 1-34, Calcitriol & Calcium
- First posted
- 1999-11-04
- Last updated
- 2015-12-15
- Results first posted
- 2015-12-15
- Limitations and caveats
- Study reported here was the primary long-term study for adults with hypoparathyroidism. Subsequent studies included additional patients.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Serum Calcium Level | 3 years | 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. |
| Primary | Urine Calcium Excretion Level | 3 years | 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. |
| Secondary | Serum 1,25-hydroxyvitamin D Level | 3 years | 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. |
| Secondary | Serum 25-hydroxyvitamin D Level | 3 years | 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. |
| Secondary | Serum Magnesium Level | 3 years | 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. |
| Secondary | Serum Phosphorus Level | 3 years | 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. |
| Secondary | Urinary Creatinine Clearance | 3 years | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Serum 1,25-hydroxyvitamin D Level | 3 years | All patients on the study | pg/ml | MEAN |
| SECONDARY | Serum 25-hydroxyvitamin D Level | 3 years | All patients on the study | ng/ml | MEAN |
| PRIMARY | Serum Calcium Level | 3 years | All patients on the study | mmol/liter | MEAN |
| SECONDARY | Serum Magnesium Level | 3 years | All patients on the study | mmol/liter | MEAN |
| SECONDARY | Serum Phosphorus Level | 3 years | All patients on the study | mmol/liter | MEAN |
| SECONDARY | Urinary Creatinine Clearance | 3 years | All patients on the study | ml/min | MEAN |
| PRIMARY | Urine Calcium Excretion Level | 3 years | All patients on the study | mmol/24 h | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Serum 1,25-hydroxyvitamin D Level | Calcitriol and Calcium | 40 | Standard Deviation 5 | pg/ml | |
| Serum 1,25-hydroxyvitamin D Level | PTH 1-34 | 43 | Standard Deviation 5 | pg/ml | |
| Serum 25-hydroxyvitamin D Level | Calcitriol and Calcium | 31 | Standard Deviation 5 | ng/ml | |
| Serum 25-hydroxyvitamin D Level | PTH 1-34 | 28 | Standard Deviation 4 | ng/ml | |
| Serum Calcium Level | Calcitriol and Calcium | 2 | Standard Deviation 0.01 | mmol/liter | |
| Serum Calcium Level | PTH 1-34 | 1.92 | Standard Deviation 0.02 | mmol/liter | |
| Serum Magnesium Level | Calcitriol and Calcium | 0.75 | Standard Deviation 0.01 | mmol/liter | |
| Serum Magnesium Level | PTH 1-34 | 0.73 | Standard Deviation 0.02 | mmol/liter | |
| Serum Phosphorus Level | Calcitriol and Calcium | 4.5 | Standard Deviation 0.05 | mmol/liter | |
| Serum Phosphorus Level | PTH 1-34 | 4.6 | Standard Deviation 0.08 | mmol/liter |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Calcitriol and Calcium | 13 | |
| Overall Study | STARTED | PTH 1-34 | 14 | |
| Overall Study | COMPLETED | Calcitriol and Calcium | 13 | |
| Overall Study | COMPLETED | PTH 1-34 | 14 | |
| Overall Study | NOT COMPLETED | Calcitriol and Calcium | 0 | |
| Overall Study | NOT COMPLETED | PTH 1-34 | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PTH 1-34 | ||
| Total, all-cause mortality | Calcitriol & Calcium | ||
| Total, other adverse events | PTH 1-34 | 0 | 14 |
| Total, other adverse events | Calcitriol & Calcium | 0 | 13 |
| Total, serious adverse events | PTH 1-34 | 0 | 14 |
| Total, serious adverse events | Calcitriol & Calcium | 0 | 13 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| PTH 1-34 vs Calcitriol & Calcium: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00001304
GET https://conductscience.org/api/trials/v1/NCT00001304/registered