NCT05946278 Genetic Regulators of Bone Health That Are Unique to Vertebral Bone
| NCT ID | NCT05946278 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Age-Related Osteoporosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 550 participants |
| Start Date | 2024-04 |
| Primary Completion | 2030-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 550 participants in total. It began in 2024-04 with a primary completion date of 2030-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Cheryl L Ackert-Bicknell, PhD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT05946278 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Age-Related Osteoporosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05946278 currently recruiting?
Yes, NCT05946278 is actively recruiting participants. Contact the research team at CHERYL.ACKERT-BICKNELL@CUANSCHUTZ.EDU for enrollment information.
Where is the NCT05946278 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT05946278 clinical trial?
NCT05946278 is sponsored by University of Colorado, Denver. The principal investigator is Cheryl L Ackert-Bicknell, PhD at University of Colorado, Denver. The trial plans to enroll 550 participants.