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Pee power: urine test may replace needles for brittle bone diagnosis

NCT ID NCT02531087

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether a urine test can help identify different genetic types of osteogenesis imperfecta (OI), a rare condition that causes bones to break easily. Researchers will measure certain collagen peptides in the urine of 25 people with OI. If successful, this could replace the need for blood or skin biopsies to determine the OI subtype.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

25 people

The number who actually took part.

Started

Aug 2015

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Individuals with OI

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Hospital for Special Surgery

    New York, New York, 10021, United States

  • Oregon Health Science University

    Portland, Oregon, 97239, United States

  • Shriners Hospital for Children

    Milwauke, Wisconsin, 53201, United States

  • Shriners Hospital for Children

    Montreal, Quebec, H3G 1A6, Canada

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

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