Bone Mineral Density in Adults With Hyperphenylalaninemia on Kuvan Therapy

Stopped early · Not applicable

Conditions studied: Hyperphenylalaninemia, Phenylketonuria

In brief

Prospective study to compare the bone mineral density in adults with HPA on KUVAN™ therapy to those not on therapy. The investigators hypothesize that after one year of KUVAN™ therapy, there will be an improvement in their bone mineral density.

Key facts

Study ID

NCT01541397

Run by

The University of Texas Health Science Center, Houston

People needed

6

Starts

2011-06-01

Expected to finish

2012-08-01

Last updated by the study team

2015-07-07

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Diagnosis of hyperphenylalaninemia at birth
• Age between 18 and 50 years
• Participated in study HSC-MS-110-0262

You may not qualify if…

• 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.

Where it is running

• The University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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