OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
NCT Number: NCT02534714
The purpose of this study is to determine if there is correlation between Vitamin D deficiency and spinal disease/spinal fusion surgery.
Looking for future studies?
Notify Me50 year and older
All sexes
Observational
Peoria, Illinois, 61637, United States
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
Part 2- Prospective Study (screening period July 1, 2015-June 30, 2016)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
(Part 1, Retrospective Study)
Inclusion criteria
Exclusion criteria
(Part 2, Observational Study)
(Screening period July 1, 2015-June 30, 2016)
Inclusion criteria
Exclusion criteria
Time frame: Within 30 days (pre-op)
Prospective Vitamin D lab of 25 Hydroxyvitamin D Total <30 ng/ml in the population >50 years old will have increased incidence of progressive spinal disease.
Time frame: Pre-op and at 3, 6, 12 months post-op
Time frame: Within 2 years prior to spinal surgery
Categorized as normal, osteopenia, and osteoporosis
Time frame: Screening
Gender, Age, Ethnicity
Time frame: Screening - immediately post-op
Medical History, BMI, smoking status, supplementation
Time frame: Screening
Gender, Age, Ethnicity
Time frame: Screening - 12 months post-op
Family history osteoporosis, smoking status, calcium and vitamin D supplementation, and diabetes
OSF Healthcare System
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01315366
Avitaminosis, Body Weight
Beirut, Lebanon
View Trial DetailsNCT05372224
Avitaminosis, Bone Diseases
Mexico City, Gustavo A. Madero, Mexico
View Trial DetailsNCT05347082
Avitaminosis, Bone Diseases
Mexico City, Mexico
View Trial DetailsNCT06551688
Avitaminosis, Breast Diseases
El Fayoum Qesm, Faiyum Governorate, Egypt
View Trial Details