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The purpose of this study is to determine if there is correlation between Vitamin D deficiency and spinal disease/spinal fusion surgery.
Bone Health is becoming of great concern in the population \> 50 years old in the past several decades. Literature review has detected a high incidence of patients with hypovitaminosis D and back pain. Vitamin D Deficiency is in all races, age groups, and ethnic backgrounds affecting greater than one billion people worldwide1. There is a higher incidence of Vitamin D Deficiency noted in the northern states. Adequate Vitamin D is essential in bone health and muscle function. It also has been reported to have positive effects on decreasing myopathy and /or musculoskeletal pain. Vitamin D has been shown to have a protective effect on fracture risk by providing increased bone matrix and on fall prevention through improved muscle function. 2 Deficiency of this vitamin can lead to impaired bone mineralization and bone softening diseases including osteomalacia and osteoporosis in adults. Osteomalacia has significant risk factors for vertebral fractures, and spinal instrumentation failure. Low-energy fractures or fragility fractures have been found to be more common because of an increase in life expectancy 3. The total 25-hydroxyvitamin D (25-OH-VitD) level (the sum of 25-OH-vitamin D2 and 25-OH-vitamin D3) is the appropriate indicator of vitamin D body stores. Presently, there is no universal consensus about a treatment cut point. Studies suggest \>30 ng/mL as the minimal concentration of 25-OH-Vit D Total is needed to avoid the adverse effects of deficiency4. Vitamin D insufficiency is considered at \<30ng/ml to 21 ng/ml and Vitamin D Deficiency is \<20 ng/ml of 25-OH-Vit D Total. Several researches have indicated increasing Vitamin D levels \>45 ng/ml will increase their immune system, bone health, lower risks of neurological disorders and cancers. 3,4 Influential pathophysiological changes in osteoporosis include the hyperactivity of osteoclasts compared to the need for bone remodeling or a decreased activity of osteoblasts compared to the need for bone cavity repair or laying down new bone.5 Osteoporosis has become synonymous with decreased bone mineral density (BMD). Bone Marrow Density scans (DXA) allows accurate diagnosis of osteoporosis, estimation of fracture risk, and monitoring of patients undergoing treatment.5 In postmenopausal women and men age 50 years and older, the WHO diagnostic T-score criteria categorizes a normal DXA scan of \<1.0 or above, low bone mass or osteopenia has a T score between \<1.0 and -2.5, and osteoporosis is designated with a T-score at -2.5 or below) are applied to BMD measurement by central DXA at the lumbar spine and femoral neck. 5 This study was done in two parts. Part 1 was the Retrospective Study from November 1, 2012 to October 31, 2014 and Part 2 is the Prospective pilot from July 1, 2015-June 30, 2016. We are anticipating to raise the awareness and identify the importance of evaluating for hypovitaminosis D and bone marrow density preoperatively in Neurosurgery Clinic for 12 months. Our goal is to show treating bone health in spinal diseased patients preoperatively will provide optimal bone health with better long term outcomes requiring less revision surgeries for our patients. Research Question: Part 1 - Retrospective Study 1\. What is the prevalence of Vitamin D Deficiency in patients over 50 undergoing spinal fusion surgery by Dr. Daniel Fassett, MD, MBA, Neurosurgeon? Part 2- Prospective Study (screening period July 1, 2015-June 30, 2016) 1. What is the prevalence of Vitamin D Deficiency in patients over 50 undergoing spinal fusion surgery by Dr. Daniel Fassett, MD, MBA, Neurosurgeon? 2. Do patients with Hypovitaminosis D maintain therapeutic levels between 45 ng/ml to 75 ng/ml in approximately 3, 6, and 12 months postoperatively with supplements of Vitamin D3? 3. What are the incidences of osteopenia and osteoporosis in elective spinal fusion patients based on a Dexascans in patients over 50 undergoing spinal fusion surgery by Dr. Daniel Fassett, MD, MBA, Neurosurgeon? 4. Do the patients' demographic information, such as age, sex, BMI, and family history influence the outcome measures (Vitamin D deficiency, Osteopenia, and Osteoporosis)?
Age
50 - No limit years
Sex
ALL
Healthy Volunteers
No
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Start Date
July 1, 2015
Primary Completion Date
June 1, 2017
Last Updated
August 28, 2018
460
ACTUAL participants
Lead Sponsor
OSF Healthcare System
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07281586