Genetic Regulators of Bone Health That Are Unique to Vertebral Bone

NCT ID: NCT05946278

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 550 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2030-08-30

Brief Summary

Osteoporosis is an age related disease in which a person's bone slowly becomes weaker with time. The bones may become so weak that they break easily such as a fall from standing height. The most commonly broke bones in osteoporosis are those of the hip, the spine or the wrist. Osteoporosis runs in families meaning that genetic differences explain why some people break bones in old age and other do not. Genetic studies have been done that show the the genes associated with spine (vertebral) fractures (broken bones) and hip fractures are different, suggesting that osteoporosis of the spine is not the exact same disease as osteoporosis of the hip. Genetic studies tell us what part of the genome (i.e. genes) are associated with a disease, but do not tell us how these genes act biologically to cause that disease. In this study, we seek to determine how the genes uniquely associated with spine osteoporosis behave in normal and aged bone, to determine how they interact with each other as a team to impact spine bone. In this study, we will measure gene activity (so called gene expression) in bone samples taken from people undergoing major spine deformity surgery. We will using genetic data from these patients to determine how gene activity is controlled in bone and how that relates to measures of bone health such as bone mineral density data. The results of this study will provide critical data regarding how osteoporosis of the spine happens, and these data will be used to find better and safer treatments to prevent bone fractures of the spine that happen with age.

Conditions

Age-Related Osteoporosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients undergoing deformity correction surgery

Patients undergoing deformity correction surgery undergoing a multi-level spinal fusion (i.e. a T10 (or higher) fusion to the pelvis) -OR- a 3 column osteotomy with a corpectomy from for short segment surgeries -OR- a vertebral column resection (VCR) involving a corpectomy -OR- any deformity correction surgery wherein the attending surgeon determines that a large amount of bone containing trabecular elements will be removed and discarded

Sample collection for gene expression

Intervention Type: OTHER

This is a cross-sectional sample collection study. Vertebral bone tissue that would otherwise be discarded is collected from patients undergoing surgery to correct a spine deformity and gene expression is measure in these tissues.

Interventions

Sample collection for gene expression

This is a cross-sectional sample collection study. Vertebral bone tissue that would otherwise be discarded is collected from patients undergoing surgery to correct a spine deformity and gene expression is measure in these tissues.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Men and women between the ages of 18 and 85 undergoing a multi-level spinal fusion (i.e. a T10 (or higher) fusion to the pelvis) -OR- a 3 column osteotomy with a corpectomy from for short segment surgeries -OR- a vertebral column resection (VCR) involving a corpectomy -OR- any deformity correction surgery wherein the attending surgeon determines that a large amount of bone containing trabecular elements will be removed and discarded.
• Willing and able to provide informed consent

Exclusion Criteria

• End stage renal disease.
• Any history of cancer.
• Reliance on a wheelchair for 70% or greater of their mobility for longer than 12 months.
• Quadra or paraplegia due to spinal cord injury.
• Current use of epilepsy medications.
• Confirmed Marfans, osteogenesis imperfecta or other genetic syndrome known to impact bone formation (Guacher's, Vit D independent rickets, etc).
• Current glucocorticoid use lasting longer than 3 months, or greater than 6 months lifetime use.
• Current or suspected current infection associated with orthopedic hardware.
• HIV or Hep C positive and or currently on anti-viral medications.
• History of gastric bypass surgery and or weigh loss exceeding 100 pounds.
• Primary or secondary hyperparathyroidism.
• Paget's disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheryl L Ackert-Bicknell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Univeristy of Colorado Denver

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cheryl L Ackert-Bicknell, PhD

Role: CONTACT

CHERYL.ACKERT-BICKNELL@CUANSCHUTZ.EDU

3037246623

Facility Contacts

Cheryl L Ackert-Bicknell@cuAnschutz.edu, PhD

Role: primary

cheryl.ackert-bicknell@cuanschutz.edu

303-724-6623

Reed A Ayers, PhD

Role: backup

reed.ayers@cuanschutz.edu

303-724-1158

Other Identifiers

23-0602

Identifier Type: -

Identifier Source: org_study_id