Exploring genetic factors affecting spine bone health in osteoporosis
Official title: Identification and Characterization of Genetic Regulators of Bone Health That Are Unique to Vertebral Bone.
Run by University of Colorado, Denver · NCT05946278 · Data updated 2026-11-12
This study is trying to find out how certain genes affect spine bone health in older people with osteoporosis to understand why some are more likely to have fractures than others.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 550 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Status | Recruiting |
| Started | April 2024 |
| Main results expected | August 30, 2030 |
| Study ends | August 30, 2030 |
| Registry record updated | April 3, 2024 |
| Trial ID | NCT05946278 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include men and women aged 18 to 85 who are undergoing specific spinal surgeries that involve significant bone removal.
✕Probably not a fit
Patients with end-stage renal disease, a history of cancer, or certain genetic syndromes affecting bone formation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the genetic regulators specifically associated with age-related osteoporosis of the spine. By analyzing samples collected during spinal surgeries, the research aims to understand how these genes function in normal and aged bone, and how they interact with one another. The study focuses on identifying genetic differences that may explain why some individuals are more prone to vertebral fractures than others. This could lead to a better understanding of osteoporosis as a distinct condition affecting the spine compared to other types of osteoporosis.
Why it matters
Potential benefit: If successful, this study could provide insights that lead to targeted therapies for preventing vertebral fractures in patients with osteoporosis.
How similar studies have gone: While genetic studies in osteoporosis have been conducted, this specific focus on vertebral bone health is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Univeristy of Colorado Denver
Aurora, Colorado, United States Recruiting
Study contacts
- Principal investigator: Cheryl L Ackert-Bicknell, PhD — University of Colorado, Denver
- Study coordinator: Cheryl L Ackert-Bicknell, PhD
- Email: CHERYL.ACKERT-BICKNELL@CUANSCHUTZ.EDU
- Phone: 3037246623
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.