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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.

Register:	ClinicalTrials.gov
Last refreshed on:	20 November 2023
Main ID:	NCT02531087
Date of registration:	20/08/2015
Prospective Registration:	Yes
Primary sponsor:	Baylor College of Medicine
Public title:	Urinary Biomarkers of OI Pathobiology
Scientific title:	Cross-Linked Collagen Peptides as a Urinary Biomarker of OI Pathobiology
Date of first enrolment:	September 2015
Target sample size:	25
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT02531087
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Canada	United States

Contacts

Name:	David Eyre, Ph.D.
Address:
Telephone:
Email:
Affiliation:	University of Washington

Name:	Frank Rauch, M.D.
Address:
Telephone:
Email:
Affiliation:	Shriners Hospital for Children

Name:	Vernon Reid Sutton, M.D.
Address:
Telephone:
Email:
Affiliation:	Baylor College of Medicine

Key inclusion & exclusion criteria

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.

Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Osteogenesis Imperfecta

Intervention(s)

Primary Outcome(s)

HP/LP Ratio [Time Frame: 5 Years]

Secondary Outcome(s)

HP/LP ratio [Time Frame: 5 Years]

Secondary ID(s)

37358

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Shriners Hospitals for Children

University of Nebraska

University of Washington

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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