Actively Recruiting

Age: 18Years - 85Years
All Genders
NCT05946278

Genetic Regulators of Bone Health That Are Unique to Vertebral Bone

Led by University of Colorado, Denver · Updated on 2024-04-03

550

Participants Needed

1

Research Sites

334 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

U

University of Virginia

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Genetic Regulators of Bone Health That Are Unique to Vertebral Bone

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women between the ages of 18 and 85 undergoing a multi-level spinal fusion (T10 or higher) to the pelvis, a 3 column osteotomy with corpectomy, vertebral column resection, or any large bone removal deformity correction surgery
  • Willing and able to provide informed consent
Not Eligible

You will not qualify if you...

  • End stage renal disease
  • Any history of cancer
  • Wheelchair reliance for 70% or more of mobility for longer than 12 months
  • Quadra or paraplegia due to spinal cord injury
  • Current use of epilepsy medications
  • Confirmed Marfan syndrome, osteogenesis imperfecta, or other genetic bone disorders
  • Current glucocorticoid use longer than 3 months or over 6 months lifetime use
  • Current or suspected infection related to orthopedic hardware
  • HIV or Hepatitis C positive or on antiviral medications
  • History of gastric bypass surgery or weight loss over 100 pounds
  • Primary or secondary hyperparathyroidism
  • Paget's disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Univeristy of Colorado Denver

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

C

Cheryl L Ackert-Bicknell, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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