Trial · NCT00417612
Effectiveness of Paricalcitol in Reducing Parathyroid Hormone (PTH) Levels in X-linked Hypophosphatemic Rickets
NCT00417612, Phase 3, Completed, Yale University; results first posted 2014-10-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effectiveness of Paricalcitol in Reducing Parathyroid Hormone (PTH) Levels in X-linked Hypophosphatemic Rickets. Trials, record NCT00417612. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00417612
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness of Paricalcitol in Reducing Parathyroid Hormone (PTH) Levels in X-linked Hypophosphatemic Rickets
- NCT number
- NCT00417612
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 33 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Hypophosphatemia, Familial, Hyperparathyroidism
- Interventions
- Paricalcitol, Placebo
- First posted
- 2007-01-01
- Last updated
- 2020-03-17
- Results first posted
- 2014-10-28
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Curve for Parathyroid Hormone (PTHauc) Measurement | Measured at baseline and Month 12 | Mean area under the curve for parathyroid hormone levels (PTHauc) sampled during a 26 hour study period, for Paricalcitol (Active Drug) and Placebo groups at Baseline and Month 12 . |
| Primary | Area Under the Curve for Parathyroid Hormone (PTH; Percentage Decrease) | Measured at baseline and Month 12 | Mean PTHauc (% decrease) for Paricalcitol (Active Drug) and Placebo from Baseline to Month 12. |
| Primary | Reduction of Parathyroid Hormone Area Under the Curve (PTHauc) of 20% or Greater | Measured at baseline and Month 12 | Clinically significant reduction of Mean PTHauc (% decrease \>/= 20) for Paricalcitol (Active Drug) and Placebo from Baseline to Month 12. |
| Secondary | Static Parameters of Serum Alkaline Phosphatase at Baseline and 1 Year for Paricalcitol and Placebo Arms. | Measured at baseline and Month 12 | |
| Secondary | Serum Calcium | Measured at baseline and Month 12 | |
| Secondary | Bone Scan Severity Score | Measured at baseline and Month 12 | 99-Tc-methylenediphosphonate bone scans were completed and analyzed using the following scale\*: Bone scan severity scale with minimum score of 0 and maximum score of 4 (0 is no disease and 4 is greatest severity of disease). Appearance of lumbar spine and the sacroiliac region were used as internal references to which all suspected lesions were compared, and scored as follows: grade 0, normal scan without suspicious lesions grade 1, lesion(s) less intense than normal lumbar spine grade 2, lesion(s) similar in intensity to normal lumbar spine grade 3, lesions more intense than normal lumbar spine but similar to the normal sacroiliac region grade 4, lesions more intense than the normal sacroiliac region. \*devised by nuclear medicine radiologist at Yale New Haven Hospital |
| Secondary | Percent Change in Urinary Calcium Excretion From Baseline to 1 Year | Measured at baseline and Month 12 | Percent change in daily urinary calcium excretion, which is calculated the measurements of the calcium in the subject's 24-hr urine collections done at baseline and at the 1 year timepoints |
| Secondary | Serum Intact Fibroblast Growth Factor 23 (FGF23) | Measured at baseline and Month 12 | |
| Secondary | Serum 1,25 (OH)2D | Measured at baseline and Month 12 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Curve for Parathyroid Hormone (PTHauc) Measurement | Measured at baseline and Month 12 | nlEq*26hr/ml | MEAN | |
| SECONDARY | Static Parameters of Serum Alkaline Phosphatase at Baseline and 1 Year for Paricalcitol and Placebo Arms. | Measured at baseline and Month 12 | Alkaline phosphatase activity was analyzed separately for children (less than 18 years of age) and adults as values varied considerably between these two groups. In other outcome measure modules the paricalcitol group is comprised of 19 participants analyzed which includes adults and children. In this module, the children (2) are their own arm. | mg/dl | MEAN |
| SECONDARY | Serum Calcium | Measured at baseline and Month 12 | mg/dl | MEAN | |
| SECONDARY | Bone Scan Severity Score | Measured at baseline and Month 12 | units on a scale | MEAN | |
| SECONDARY | Percent Change in Urinary Calcium Excretion From Baseline to 1 Year | Measured at baseline and Month 12 | percent change | MEAN | |
| SECONDARY | Serum Intact Fibroblast Growth Factor 23 (FGF23) | Measured at baseline and Month 12 | pg/ml | MEAN | |
| SECONDARY | Serum 1,25 (OH)2D | Measured at baseline and Month 12 | pg/ml | MEAN | |
| PRIMARY | Area Under the Curve for Parathyroid Hormone (PTH; Percentage Decrease) | Measured at baseline and Month 12 | participants | NUMBER | |
| PRIMARY | Reduction of Parathyroid Hormone Area Under the Curve (PTHauc) of 20% or Greater | Measured at baseline and Month 12 | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Curve for Parathyroid Hormone (PTHauc) Measurement | Paricalcitol (Active Drug) | Baseline | 1223 | Standard Deviation 426 | nlEq*26hr/ml |
| Area Under the Curve for Parathyroid Hormone (PTHauc) Measurement | Placebo | Baseline | 1449 | Standard Deviation 865 | nlEq*26hr/ml |
| Area Under the Curve for Parathyroid Hormone (PTHauc) Measurement | Paricalcitol (Active Drug) | Month 12 | 987 | Standard Deviation 372 | nlEq*26hr/ml |
| Area Under the Curve for Parathyroid Hormone (PTHauc) Measurement | Placebo | Month 12 | 1616 | Standard Deviation 945 | nlEq*26hr/ml |
| Static Parameters of Serum Alkaline Phosphatase at Baseline and 1 Year for Paricalcitol and Placebo Arms. | Paricalcitol (Active Drug) | Serum Alkaline Phosphatase (Baseline) | 141 | Standard Deviation 96 | mg/dl |
| Static Parameters of Serum Alkaline Phosphatase at Baseline and 1 Year for Paricalcitol and Placebo Arms. | Placebo | Serum Alkaline Phosphatase (Baseline) | 96 | Standard Deviation 28 | mg/dl |
| Static Parameters of Serum Alkaline Phosphatase at Baseline and 1 Year for Paricalcitol and Placebo Arms. | Paricalcitol (Children Ages 9-17) | Serum Alkaline Phosphatase (Baseline) | 354 | Standard Deviation 2 | mg/dl |
| Static Parameters of Serum Alkaline Phosphatase at Baseline and 1 Year for Paricalcitol and Placebo Arms. | Paricalcitol (Active Drug) | Serum Alkaline Phosphatase (1 Year) | 112 | Standard Deviation 70 | mg/dl |
| Static Parameters of Serum Alkaline Phosphatase at Baseline and 1 Year for Paricalcitol and Placebo Arms. | Placebo | Serum Alkaline Phosphatase (1 Year) | 98 | Standard Deviation 34 | mg/dl |
| Static Parameters of Serum Alkaline Phosphatase at Baseline and 1 Year for Paricalcitol and Placebo Arms. | Paricalcitol (Children Ages 9-17) | Serum Alkaline Phosphatase (1 Year) | 402 | Standard Deviation 211 | mg/dl |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Paricalcitol (Active Drug) | 22 | |
| Overall Study | STARTED | Placebo | 11 | |
| Overall Study | COMPLETED | Paricalcitol (Active Drug) | 19 | |
| Overall Study | COMPLETED | Placebo | 8 | |
| Overall Study | NOT COMPLETED | Paricalcitol (Active Drug) | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Elevated Serum Creatinine | Renal and urinary disorders | Paricalcitol (Active Drug) | 1 | 22 | 1 |
| other | Elevated Serum Creatinine | Renal and urinary disorders | Placebo | 0 | 11 | 0 |
| other | Hypercalcemia | Blood and lymphatic system disorders | Paricalcitol (Active Drug) | 1 | 22 | 1 |
| other | Hypercalcemia | Blood and lymphatic system disorders | Placebo | 0 | 11 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paricalcitol (Active Drug) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Paricalcitol (Active Drug) | 2 | 22 |
| Total, other adverse events | Placebo | 0 | 11 |
| Total, serious adverse events | Paricalcitol (Active Drug) | 0 | 22 |
| Total, serious adverse events | Placebo | 0 | 11 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P50AR054086 | NIAMS: CORT | CARPENTER, THOMAS O | YALE UNIVERSITY | NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES | 2006 to 2010 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Paricalcitol (Active Drug) vs Placebo: 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/NCT00417612
GET https://conductscience.org/api/trials/v1/NCT00417612/results?page=2