Osteoporosis Clinical Trial
Official title:
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 July 1, 2015-June 30, 2016
NCT number | NCT02534714 |
Other study ID # | 632002 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 2015 |
Verified date | August 2018 |
Source | OSF Healthcare System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to determine if there is correlation between Vitamin D deficiency and spinal disease/spinal fusion surgery.
Status | Completed |
Enrollment | 460 |
Est. completion date | |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
(Part 1, Retrospective Study) Inclusion Criteria: 1. 50 years old or older. 2. Patients with any form of spinal fusion surgery performed by Dr. Daniel Fassett, MD, MBA, Neurosurgeon at OSF-INI from November 1, 2012 to October 31, 2014. Exclusion Criteria: 3. Subjects diagnosed with chronic renal disease Stage IV or V, metastatic spinal disease, bariatric surgery, malabsorption syndrome, seizure medication and chronic steroid use greater than 3 months at time of surgery. (Part 2, Observational Study) (Screening period July 1, 2015-June 30, 2016) Inclusion Criteria: 1. 50 years old or older. 2. Serum Vitamin D level checked prior to or at surgery. 3. BMD exam performed anytime within 2 years prior to surgery. 4. Patients with any form of spinal fusion cervical, thoracic, lumbar, surgery performed by Dr. Daniel Fassett, MD, MBA, Neurosurgeon at OSF-INI from July 1, 2015 to May 31, 2016. Exclusion Criteria: 5. Subjects diagnosed with: - Chronic Renal Disease with a GFR < 45 at Stage IV - Metastatic Spinal Disease - Bariatric surgery - Seizure medication - Chronic steroid use greater than 3 months at time of surgery. |
Country | Name | City | State |
---|---|---|---|
United States | OSF Saint Francis Medical Center | Peoria | Illinois |
Lead Sponsor | Collaborator |
---|---|
OSF Healthcare System | University of Illinois College of Medicine at Peoria |
United States,
Blake GM, Fogelman I. The role of DXA bone density scans in the diagnosis and treatment of osteoporosis. Postgrad Med J. 2007 Aug;83(982):509-17. Review. — View Citation
Bogunovic L, Kim AD, Beamer BS, Nguyen J, Lane JM. Hypovitaminosis D in patients scheduled to undergo orthopaedic surgery: a single-center analysis. J Bone Joint Surg Am. 2010 Oct 6;92(13):2300-4. doi: 10.2106/JBJS.I.01231. — View Citation
Dipaola CP, Bible JE, Biswas D, Dipaola M, Grauer JN, Rechtine GR. Survey of spine surgeons on attitudes regarding osteoporosis and osteomalacia screening and treatment for fractures, fusion surgery, and pseudoarthrosis. Spine J. 2009 Jul;9(7):537-44. doi: 10.1016/j.spinee.2009.02.005. Epub 2009 Mar 28. — View Citation
Heaney RP. Vitamin D: how much do we need, and how much is too much? Osteoporos Int. 2000;11(7):553-5. — View Citation
Kim TH, Yoon JY, Lee BH, Jung HS, Park MS, Park JO, Moon ES, Kim HS, Lee HM, Moon SH. Changes in vitamin D status after surgery in female patients with lumbar spinal stenosis and its clinical significance. Spine (Phila Pa 1976). 2012 Oct 1;37(21):E1326-30. — View Citation
Manolagas SC. Birth and death of bone cells: basic regulatory mechanisms and implications for the pathogenesis and treatment of osteoporosis. Endocr Rev. 2000 Apr;21(2):115-37. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | (Part 1, Retrospective Study) Serum vitamin D 25 Hydroxy Level | 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. | Within 30 days (pre-op) | |
Primary | (Part 2, Prospective Study) Serum vitamin D 25 Hydroxy Level | 1. Vitamin D values. We will categorize it to different levels: if the value is <30 ng/ml to 21 ng/ml-then it is insufficient; if the value is <20 ng/ml, then it is deficient. | Pre-op and at 3, 6, 12 months post-op | |
Primary | (Part 2, Prospective Study) Bone Marrow Density Results (DMD, DEXA) | Categorized as normal, osteopenia, and osteoporosis | Within 2 years prior to spinal surgery | |
Secondary | (Part 1) Demographics | Gender, Age, Ethnicity | Screening | |
Secondary | (Part 1) Medical History | Medical History, BMI, smoking status, supplementation | Screening - immediately post-op | |
Secondary | (Part 2) Demographics | Gender, Age, Ethnicity | Screening | |
Secondary | (Part 2 ) Medical History | Family history osteoporosis, smoking status, calcium and vitamin D supplementation, and diabetes | Screening - 12 months post-op |
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