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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01541397 |
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Date of registration:
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11/07/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Bone Mineral Density in Adults With Hyperphenylalaninemia on Kuvan Therapy
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Scientific title:
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Bone Mineral Density in Adults With Hyperphenylalaninemia on Kuvan Therapy |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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6 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01541397 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Heather W Saavedra, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of Texas Health Science Center, Houston |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of hyperphenylalaninemia at birth
- Age between 18 and 50 years
- Participated in study HSC-MS-110-0262
Exclusion Criteria:
- Peri-menopausal and menopausal women will be excluded because this is a time of
increased bone loss related to hormonal mediated factors.
- Patients taking bisphosphonates because it alters bone density. Therefore, bone
mineral density would reflect the biphosphonate intervention rather than their true
status.
- Pregnant women due to the hazard of radiation exposure during a DXA scan. In addition
women who have been pregnant or who have breastfed within one year of study enrollment
will be excluded because these are periods of rapid bone loss which would not reflect
the entity under study but would serve to confound the data.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Phenylketonuria
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Hyperphenylalaninemia
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Intervention(s)
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Drug: Sapropterin
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Primary Outcome(s)
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Bone Mineral Density
[Time Frame: 1 year after initiation of Kuvan therapy]
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Secondary Outcome(s)
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Diet Analysis
[Time Frame: every 3 months up to 1 year]
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Plasma Phenylalanine Levels
[Time Frame: weekly for 6 weeks, then at least every three months up to 1 year]
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Plasma Amino Acid Profile
[Time Frame: every three months up to 1 year]
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Secondary ID(s)
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HSC-MS-11-0119
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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