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Clinical Trials in Canada / NCT02531087
Active, not recruiting Observational

Urinary Biomarkers of OI Pathobiology

NCT02531087 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2015-08-17
Last updated
2025-12-01

Condition(s) studied

Osteogenesis Imperfecta

Study summary

Osteogenesis imperfecta (OI) is a rare inherited disorder that causes bones to break easily. Individuals with osteogenesis imperfecta break bones often and may have other problems, including hearing loss, dental problems, pain and difficulty getting around. Before the genetic cause of OI was known, OI was classified into four types. Each type was based upon the symptoms and severity of OI. In most people with OI, the cause is a change in one of the genes that makes a protein called type 1 collagen. Some doctors now classify OI both on how severe it is as well as which gene is causing OI. When people classify OI this way, there are more than 10 types of OI. The current laboratory testing to determine OI subtype involves the collection of blood and/or skin cells.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * To be able to participate, you must: Be enrolled in The Longitudinal Study of OI (NTC #02432625) and have one of the following genetic mutations: * glycine substitution mutations in COL1A1 or COL1A2 * haploinsufficient mutation in COL1A1 or COL1A2 * mutations in CRTAP, PPIB, or LEPRE1 * mutations in FKBP10 or SERPINH1 * mutations in (SERPINF1, WNT1, or IFITM5) * dominant negative glycine substitutions and haploinsufficient mutations in COL1A1, and COL1A2 If you are serving as a control, you must not be related to an individual with OI. Exclusion Criteria: * You cannot participate if: * You are unable to comply with the sample collection schedule. * You are related to one of the OI subjects and would like to serve as a control subject. * You have vertebral instrumentation or spinal deformities where we cannot assess lumbar spine aBMD. * You have a history of recent fracture (\< 3 months). * You have serum creatinine above 1x upper limits of normal. * You have abnormal kidney function. * You are using Minoxidil. * You are unable to provide a urine sample readily.

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
University of California Los Angeles Los Angeles California
University of Nebraska Medical Center Omaha Nebraska
Hospital for Special Surgery New York New York
Oregon Health Science University Portland Oregon
Baylor College of Medicine Houston Texas
Shriners Hospital for Children Milwauke Wisconsin
Shriners Hospital for Children Montreal Quebec

More Baylor College of Medicine trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02531087 on ClinicalTrials.gov ↗ ← All trials in Canada