RECRUITING

Genetic Regulators of Bone Health That Are Unique to Vertebral Bone

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Identification and Characterization of Genetic Regulators of Bone Health That Are Unique to Vertebral Bone.

Quick Facts

Study Start:2024-04
Study Completion:2030-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05946278

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Willing and able to provide informed consent
  1. * End stage renal disease.
  2. * Any history of cancer.
  3. * Reliance on a wheelchair for 70% or greater of their mobility for longer than 12 months.
  4. * Quadra or paraplegia due to spinal cord injury.
  5. * Current use of epilepsy medications.
  6. * Confirmed Marfans, osteogenesis imperfecta or other genetic syndrome known to impact bone formation (Guacher's, Vit D independent rickets, etc).
  7. * Current glucocorticoid use lasting longer than 3 months, or greater than 6 months lifetime use.
  8. * Current or suspected current infection associated with orthopedic hardware.
  9. * HIV or Hep C positive and or currently on anti-viral medications.
  10. * History of gastric bypass surgery and or weigh loss exceeding 100 pounds.
  11. * Primary or secondary hyperparathyroidism.
  12. * Paget's disease

Contacts and Locations

Study Contact

Cheryl L Ackert-Bicknell, PhD
CONTACT
3037246623
CHERYL.ACKERT-BICKNELL@CUANSCHUTZ.EDU

Principal Investigator

Cheryl L Ackert-Bicknell, PhD
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

Univeristy of Colorado Denver
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Cheryl L Ackert-Bicknell, PhD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04
Study Completion Date2030-08-30

Study Record Updates

Study Start Date2024-04
Study Completion Date2030-08-30

Terms related to this study

Keywords Provided by Researchers

  • Bone mineral density, gene transcription, spine, genetic disease

Additional Relevant MeSH Terms

  • Age-Related Osteoporosis