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Bone Mineral Density in Adults With Hyperphenylalaninemia on Kuvan Therapy

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Trial Status Terminated

Trial Identifier

NCT01541397

Condition

Phenylketonuria, Hyperphenylalaninemia

The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. and has not been edited.

Trial Summary

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.

Eligibility Criteria

Birth Sex

All

Age

18 Years to 50 Years

Healthy Volunteers

Yes

Drug/Treatment:

Sapropterin

Phase:

Na

Study Type:

Interventional

Number of Participants:

6

Study Started:

2011-06

Study Updated:

2015-07-07

Trial Locations

  • The University of Texas Health Science Center at Houston

    Houston, Texas, United States

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

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