NCT00076830

Brief Summary

This study offers evaluation and treatment of patients with a suspected connective tissue disorder. The protocol is not designed to test new treatments; rather, patients receive standard care. The study is designed to: 1) allow NICHD's staff to learn more about connective tissue disorders, 2) train physicians in the evaluation and treatment of these disorders; and 3) establish a pool of patients who may be eligible for other NICHD protocols for connective tissue disorders. (Participants in this protocol will not be required to join another study; the decision will be voluntary.) Patients of all ages with a suspected connective tissue disorder and their unaffected family members may be eligible for this study. Participants undergo diagnostic procedures that may include a medical history, physical examination, X-ray studies, eye examinations, and blood drawing, as well as other specialized tests, when needed. Additional tests may include:

  • Blood test for DNA genetic analysis
  • Skin biopsy: Removal of a small piece of tissue for microscopic examination. The area of skin selected for the biopsy is numbed and a small circle of skin, usually from the upper arm, is removed with a surgical cookie cutter-like instrument.
  • Magnetic resonance imaging (MRI): This test uses a strong magnetic field and radio waves to show structural and chemical changes in tissues. The patient lies on a table that slides into a narrow cylinder containing a magnetic field. Ear plugs are worn to muffle loud knocking and thumping sounds that occur with electrical switching of the magnetic fields.
  • Computed tomography (CT) scans: This test allows the doctor to view the organs inside the body in small sections. The patient lies in a doughnut-like machine. Scanning can be done from different angles, allowing a three dimensional picture of the part of the body being studied. It may be done with or without injection of a contrast material.
  • Referral to appropriate sub-specialists when potential complications are found.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Posted

Study publicly available on registry

February 4, 2004

Completed
3 months until next milestone

Study Start

First participant enrolled

May 18, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2006

Completed
Last Updated

April 24, 2026

Status Verified

January 9, 2026

First QC Date

July 12, 2006

Last Update Submit

April 23, 2026

Conditions

Keywords

BoneGrowthSkinFractures

Outcome Measures

Primary Outcomes (1)

  • Evaluation and Diagnosis

    Evaluation of individuals with suspected bone-related connective tissue disorders and their family members

    per individual cases

Secondary Outcomes (1)

  • Biospecimens collection

    12/31/2030

Study Arms (1)

Enrolled cohort

All patients enrolled, as this is an evaluation/diagnostic study

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Minimal limit on gender, geographical location (able to travel to NIH), race/ethnicity, age (from birth to 70 years old).

You may qualify if:

  • Individuals with a suspected bone-related connective tissue disorder, as indicated by signs including, but not limited to, fractures, low bone density, asymmetric overgrowth of long bone
  • Apparently unaffected, healthy family members of individuals with a suspected bone-related connective tissue disorder.
  • Ages to be enrolled are from 0-70 years old, with only viable neonates accepted at age 0 years.

You may not qualify if:

  • Individuals who, in the opinion of the Investigator, are unable to comply with the protocol or have medical conditions that would potentially increase the risk of participation.
  • radiation, but not excluded from the study overall.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

MeSH Terms

Conditions

Connective Tissue DiseasesOsteogenesis ImperfectaBone Diseases, MetabolicMelorheostosisFractures, Bone

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesOsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCollagen DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesOsteosclerosisWounds and Injuries

Study Officials

  • Joshua J Zimmerberg, M.D.

    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2006

First Posted

February 4, 2004

Study Start

May 18, 2004

Last Updated

April 24, 2026

Record last verified: 2026-01-09

Data Sharing

IPD Sharing
Will not share

The intention of this study is for individualized, very rare explorations of conditions that may lead to clearer diagnoses for patients and/or open up avenues of further study by qualification for other trials by providing diagnosis or clinical information relevant to that disease process such as osteogenesis imperfecta or melorheostosis studies. It also allows for family member analysis of these genetic conditions for those apparently unaffected. It is considered a screening study. The IPD will not be shared as a cohort, though individual plans will be made later for those whose case studies would be published directly from data received on this protocol.

Locations