Effect of Epidural Steroid Injection on Bone Mineral Density in Postmenopausal Women
| Tracking Information | |
|---|---|
| First Received Date ICMJE | July 16, 2009 |
| Last Updated Date | March 15, 2012 |
| Start Date ICMJE | July 2007 |
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Measurements will be taken at baseline and then repeated at 3,6, and 12 months after treatment. [ Time Frame: 12 months ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00941473 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Effect of Epidural Steroid Injection on Bone Mineral Density in Postmenopausal Women |
| Official Title ICMJE | Effect of Epidural Steroid Injection on Bone Mineral Density In Postmenopausal Women |
| Brief Summary | To evaluate for the effect of corticosteroid epidural injections on bone mineral density in postmenopausal women. Candidates for the study: Post menopausal women between the ages of 55 and 80. No history of bone disease. No thyroid/parathyroid disorder. not used injected or oral steroids in the last year. No recent smoking. The purpose is to identify any significant change in bone mineral density with the use of epidural steroid injections. This may implicate the need for patient counseling regarding this possible side effect and the possible use of preventive measures to avoid this adverse effect. |
| Detailed Description | Glucocorticoids reduce bone formation and increase bone loss via a variety of mechanisms. This effect has been shown to be dose-dependent. Doses as low as 10mg of Prednisone, has been shown to lower bone density over periods as short as 20 weeks, an effect which may be prevented with use of Calcium and Vitamin D. Inhaled Tramcinilone has also been shown to lead to dose-related loss of bone at the hip in premenopausal women. Clinic visits will be arranged for recruited patients at baseline and then at 3 and 6 months after the ESI and at any time for new-onset or severe back pain. During the initial visit, consent will be obtained, patient will be given details on the study design and rationale, severity and characteristics of back pain. Epidural corticosteroid injection (ESI) has been shown to decrease pain, speed return of function, and improve neurological signs in patients presenting with low back pain. |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 4 |
| Study Design ICMJE | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Condition ICMJE |
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| Intervention ICMJE | Drug: Triamcinilone (kenalog)
Epidural steroid injection of 80mg of Triamcinilone. |
| Study Arm (s) | Active Comparator: Epidural Steriod Injection
This study focuses on the changes in bone mineral density over time of the cohort previously described in the inclusion criteria (post-menopausal white women)
Intervention: Drug: Triamcinilone (kenalog) |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 28 |
| Completion Date | July 2011 |
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria: Patients with low back pain and have consented to ESI. Age 55 and 5 years postmenopausal Caucasian women. Exclusion Criteria:
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| Gender | Female |
| Ages | 55 Years to 80 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT00941473 |
| Other Study ID Numbers ICMJE | J90067, IRB#4569, patient care #80211089 |
| Has Data Monitoring Committee | Yes |
| Responsible Party | Shlomo Mandel, Henry Ford Health System |
| Study Sponsor ICMJE | Henry Ford Health System |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Henry Ford Health System |
| Verification Date | March 2012 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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