Trial · NCT01541397
Bone Mineral Density in Adults With Hyperphenylalaninemia on Kuvan Therapy
NCT01541397, Not applicable, Terminated, The University of Texas Health Science Center, Houston; results first posted 2015-07-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bone Mineral Density in Adults With Hyperphenylalaninemia on Kuvan Therapy. Trials, record NCT01541397. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01541397
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bone Mineral Density in Adults With Hyperphenylalaninemia on Kuvan Therapy
- NCT number
- NCT01541397
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 6 participants, actual
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Hyperphenylalaninemia, Phenylketonuria
- Interventions
- Sapropterin
- First posted
- 2012-03-01
- Last updated
- 2015-07-07
- Results first posted
- 2015-07-07
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bone Mineral Density | 1 year after initiation of Kuvan therapy | A DXA scan will be conducted one year after Kuvan therapy is initiated. |
| Secondary | Plasma Amino Acid Profile | every three months up to 1 year | Evaluation of levels of plasma amino acids. |
| Secondary | Diet Analysis | every 3 months up to 1 year | Subjects will provide a 3 day diet record for every plasma amino acid evaluation. Diets will be analyzed to determine phenylalanine, protein, calories, fat, vitamins and minerals. |
| Secondary | Plasma Phenylalanine Levels | weekly for 6 weeks, then at least every three months up to 1 year | Plasma phenylalanine levels will be monitored to determine effectiveness of Kuvan therapy. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Bone Mineral Density | 1 year after initiation of Kuvan therapy | Zero participants were analyzed because the study was ended early (due to an insufficient number of enrolled participants). | ||
| SECONDARY | Plasma Amino Acid Profile | every three months up to 1 year | Zero participants were analyzed because the study was ended early (due to an insufficient number of enrolled participants). | ||
| SECONDARY | Diet Analysis | every 3 months up to 1 year | Zero participants were analyzed because the study was ended early (due to an insufficient number of enrolled participants). | ||
| SECONDARY | Plasma Phenylalanine Levels | weekly for 6 weeks, then at least every three months up to 1 year | Zero participants were analyzed because the study was ended early (due to an insufficient number of enrolled participants). |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Non-Kuvan Treated | 4 | |
| Overall Study | STARTED | Kuvan Treated | 2 | |
| Overall Study | COMPLETED | Non-Kuvan Treated | 0 | |
| Overall Study | COMPLETED | Kuvan Treated | 0 | |
| Overall Study | NOT COMPLETED | Non-Kuvan Treated | 4 | |
| Overall Study | NOT COMPLETED | Kuvan Treated | 2 |
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 | Non-Kuvan Treated | ||
| Total, all-cause mortality | Kuvan Treated | ||
| Total, other adverse events | Non-Kuvan Treated | 0 | 0 |
| Total, other adverse events | Kuvan Treated | 0 | 0 |
| Total, serious adverse events | Non-Kuvan Treated | 0 | 0 |
| Total, serious adverse events | Kuvan Treated | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01541397
GET https://conductscience.org/api/trials/v1/NCT01541397/registered