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Bone Mineral Density in Adults With Hyperphenylalaninemia on Kuvan Therapy

NCT01541397 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-07-07

Study results available
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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.

Conditions

Interventions

DRUG

Sapropterin

20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy

Sponsors & Collaborators

Principal Investigators

  • Heather W Saavedra, MS · The University of Texas Health Science Center, Houston

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01541397 on ClinicalTrials.gov