Back to search results

Observational Study of Genetic Regulators of Vertebral Bone Health

This study is looking into the genetic reasons why some people get osteoporosis (a disease that makes bones weak and easy to break) in their spine, while others don't. Researchers believe that osteoporosis in the spine might be different from osteoporosis in other parts of the body, like the hip. If you are between 18 and 85 years old and are having certain types of spinal surgery, you might be able to join. The study involves collecting a small piece of bone tissue during your surgery that would normally be thrown away. This tissue will be used to study your genes and how they affect bone health. The goal is to understand what genes are involved in making spinal bones strong or weak.

Study design
This is an observational study planning to enroll 550 participants. It is a cross-sectional sample collection study.
What's involved
You would have a small piece of vertebral bone tissue collected during your spinal surgery. This tissue would otherwise be discarded.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05946278

Genetic Regulators of Bone Health That Are Unique to Vertebral Bone

Recruiting
Not specifiedAges 18–85Observational
University of Colorado, Denver
~550 participants
Updated 2024-04-03 on ClinicalTrials.gov
What's tested:Sample collection for gene expression

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Gene and transcript quantification
Measured over Baseline
+1 more outcome measured

Conditions

Age-Related Osteoporosis

Explore related trials

Osteoporosis

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

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

Who to contact

Cheryl L Ackert-Bicknell, PhD
[email protected]
3037246623
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Gene and transcript quantificationBaseline

    The abundances (in transcripts per million, TPM) of all known transcripts will be quantified in each bone sample via next generation RNA-sequencing.

  • GenotypesBaseline

    Low coverage whole genome sequence data will be obtained from all participants and the yielded outcome will be high quality genotypes for millions of single nucleotide polymorphism (SNPs) across the patient's genome. As this is low coverage genotyping, the coverage rate will be between 1 and 0.4X representation for each spot in the genome per patients, so the data will be imputed to ensure coverage to 1X for all patients. Each patient will be genotyped and therefore, data on a per participant level will be yielded.