Advertisement

Topics

Analysis of Hypovitaminosis D and Osteopenia/Osteoporosis in Spinal Disease Patients Who Underwent a Spinal Fusion at Illinois Neurological Institute, Peoria, IL., a Retrospective Review From November 1, 2012 to October 31, 2014 and Prospective Pilot From

2015-08-30 22:46:39 | BioPortfolio

Summary

The purpose of this study is to determine if there is correlation between Vitamin D deficiency and spinal disease/spinal fusion surgery.

Description

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

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)?

Study Design

Observational Model: Cohort

Conditions

Hypovitaminosis D

Intervention

None (Observational Study)

Location

OSF Saint Francis Medical Center
Peoria
Illinois
United States
61637

Status

Recruiting

Source

OSF Healthcare System

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-08-30T22:46:39-0400

Clinical Trials [394 Associated Clinical Trials listed on BioPortfolio]

Hypovitaminosis D Prediction Score

Vitamin D has effects on many tissues, and hypovitaminosis D is frequent. In a French survey conducted among 1587 adults, vitamin D insufficiency (

Does Treatment of Hypovitaminosis D Increase Calcium Absorption?

The purpose is to perform a one-year study designed to assess whether treatment of hypovitaminosis D increases intestinal absorption of calcium, subsequent retention of calcium within bone...

Effect of Three Different Doses of Oral Cholecalciferol on 25-Hydroxyvitamin D Changes Among Epilepsy Patients With Hypovitaminosis D

To characterize the effect of three different doses of vitamin D3 supplementation on serum 25-hydroxyvitamin D (25(OH)D) changes in epilepsy patients receiving enzyme-inducing antiepilepti...

Optimal Doses of Ergocalciferol Supplementation for Treatment of Hypovitaminosis D in Adults

To investigate the optimal initial and maintenance doses of vitamin D2 supplementation for the treatment of vitamin D insufficiency in Thai adults, and to determine the prevalence of and r...

Macugen Observational Study

The objective of this observational study is to evaluate the effectiveness and safety of Macugen for treatment of wet AMD in Indian patients.Prospective, Observational, Non-interventional ...

PubMed Articles [10530 Associated PubMed Articles listed on BioPortfolio]

Hypovitaminosis D in patients undergoing kidney transplant: the importance of sunlight exposure.

Recent studies have shown a high prevalence of hypovitaminosis D, defined as a serum 25-hydroxyvitamin D level less than 30 ng/ml, in both healthy populations and patients with chronic kidney disease....

Association between hypovitaminosis D and cognitive inhibition impairment during major depression episode.

Major depressive episode (MDE) has been associated with cognitive functioning alteration and hypovitaminosis D (hypoVD), but the relationship between hypoVD, depression, and cognition is not well unde...

Postoperative Changes in Presepsin Level and Values Predictive of Surgical Site Infection After Spinal Surgery: A Single Center, Prospective Observational Study.

Single-institutional, prospective observational study.

Magic Mirror, On the Wall-Which Is the Right Study Design of Them All?-Part II.

The assessment of a new or existing treatment or other intervention typically answers 1 of 3 central research-related questions: (1) "Can it work?" (efficacy); (2) "Does it work?" (effectiveness); or ...

Observational Studies Requested by European Health Authorities: Governmental Interference or an Enhancement of Everyday Urological Practice? The Hexvix® Observational Patients Evaluation Study as an Example of What to Expect.

The Hexvix® Observational Patients Evaluation (HOPE) study was designed to determine the extent of distribution of the use of hexaminolevulinate in the diagnosis of non-muscle invasive bladder cancer...

Medical and Biotech [MESH] Definitions

A work that reports on the results of a clinical study in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study).

A work that reports on the results of a research study to evaluate interventions or exposures on biomedical or health-related outcomes. The two main types of clinical studies are interventional studies (clinical trials) and observational studies. While most clinical studies concern humans, this publication type may be used for clinical veterinary articles meeting the requisites for humans.

Works about clinical studies in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study).

Works about research studies that evaluate interventions or exposures on biomedical or health-related outcomes. The two main types of clinical studies are interventional studies (clinical trials) and observational studies.

Work consisting of a controlled study executed by several cooperating institutions.

More From BioPortfolio on "Analysis of Hypovitaminosis D and Osteopenia/Osteoporosis in Spinal Disease Patients Who Underwent a Spinal Fusion at Illinois Neurological Institute, Peoria, IL., a Retrospective Review From November 1, 2012 to October 31, 2014 and Prospective Pilot From"

Quick Search
Advertisement
 

Searches Linking to this Trial