Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT07634627

Conditions

Adolescent Idiopathic Scoliosis (AIS)

Neuromuscular Scoliosis

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Accepted

Study Details

Brief summary:

The goal of this observational study is to find clinical, demographic, and protein biomarkers that scoliosis progression (scoliosis curve increases) and/or differ between participants with scoliosis versus those without scoliosis. The investigators aim to answer the following questions:

1. Are age, sex, skeletal maturity, and family history associated with scoliosis curve progression?
2. Do protein levels differ between progressive and non-progressive cases?
3. Do protein levels change between baseline and follow-up visits in progressive and non-progressive scoliosis cases?
4. Do proteins differ between participants with AIS vs those without AIS?
5. Do proteins or change in proteins differ between participants with AIS vs those with scoliosis secondary to neuromuscular conditions.

Participants will:

  • Participate in two research visits 6-12 months apart at a Children's Hospital Colorado location.
  • Participate in a blood draw at each study visit to collect about 3 tablespoons of blood.
  • Fill out surveys yearly regarding new medical visits, pain, physical function, anxiety and depression, medical and family history, and current medications.

Conditions

Adolescent Idiopathic Scoliosis (AIS)

Neuromuscular Scoliosis

Study ID

NCT07634627

Start date

Dec 5, 2024

Status verified date

Jun, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients 10-17 years old with idiopathic or neuromuscular scoliosis with a cobb angle of 10-50° that are currently being seen for their scoliosis at a Children's Hospital Colorado location

Exclusion Criteria:

  • Children diagnosed with certain genetic conditions that affect the bones or muscles (Turner syndrome, down syndrome, Marfan syndrome, osteogenesis imperfecta, muscular dystrophy, Ehlers-Danlos syndrome, VATER/VACTERL syndrome, Rett syndrome, Prader Willi syndrome, or Angelman syndrome)
  • Patients with congenital scoliosis, early onset scoliosis (diagnosed before 9 years old), or those who have spine surgery scheduled prior to the first study visit
  • Patients whose spinal curve is >50 degrees
  • Those taking medications that may influence protein expression (baclofen, prednisone/corticosteroids, antiepileptic medications, diazepam, tizanidine, and/or dantrolene)
  • Patients who are pregnant
  • Patients with neurocognitive disorders who are non-verbal and/or non-ambulatory
  • Patients who are not receiving care for scoliosis at a Children's Hospital Colorado location

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Scoliosis cases

Participants with clinician diagnosed adolescent idiopathic scoliosis, defined as Cobb angle >=10 degrees with rotation.

Controls

Participants without adolescent idiopathic scoliosis, described as a spinal curvature (Cobb angle) of <10 degrees.

Neuromuscular scoliosis

Participants with physician confirmed scoliosis, defined as Cobb angle >=10 degrees, secondary to a neuromuscular condition.

Primary outcome measure

  • Change in curve severity [ Time Frame: Baseline and 6-12 months ]
  • Curve progression [ Time Frame: 6 to 12 months ]

Central Contacts and Locations

Central contacts

Siera R Rossi, B.S.

720-777-1050siera.rossi@cuanschutz.edu

Patrick Carry, PhD

patrick.carry@cuanschutz.edu

Locations

Children's Hospital Colorado Anschutz

Recruiting

Aurora, Colorado, United States, 80045

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • Adolescent Idiopathic Scoliosis
  • Proteomics
  • AIS
  • Idiopathic Scoliosis
  • protein biomarkers
  • biomarkers
  • plasma proteomics
  • Neuromuscular scoliosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-06-23.