Effect of Epidural Steroid Injection on Bone Mineral Density in Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shlomo Mandel, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT00941473
First received: July 16, 2009
Last updated: March 15, 2012
Last verified: March 2012

July 16, 2009
March 15, 2012
July 2007
July 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00941473 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Effect of Epidural Steroid Injection on Bone Mineral Density in Postmenopausal Women
Effect of Epidural Steroid Injection on Bone Mineral Density In Postmenopausal Women

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.

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.

Interventional
Phase 4
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • To Assess the Changes in Markers of Bone Turnover Over a Six Month Period After Epidural Steroid Inject
  • To Assess the Changes in Bone Mineral Density.
Drug: Triamcinilone (kenalog)
Epidural steroid injection of 80mg of Triamcinilone.
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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients with low back pain and have consented to ESI. Age 55 and 5 years postmenopausal Caucasian women.

Exclusion Criteria:

  1. any women who doesn't meet the inclusion criteria
  2. Women with history of a disease affection bone turnover
  3. Women taking any drugs known to influence bone metabolism
  4. Women who had smoked within the preceding year
  5. Women with abnormal serum thyrotropin concentration, or high parathyroid hormone concentratons.
  6. Women who had received more than two short courses (lasting 2 weeks or less) of oral or parenteral glucocorticoids in the preceding year or any oral or pareneteral or local (intraarticular, paraspinal,...) or inhaled glucocorticoids in the preceding year
  7. Women diagnosed with osteoporosis (T score<=2.5) on baseline DXA or had history of osteoportic fracture.
  8. Pregnant women
  9. Severe scoliosis -
Female
55 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00941473
J90067, IRB#4569, patient care #80211089
Yes
Shlomo Mandel, Henry Ford Health System
Henry Ford Health System
Not Provided
Not Provided
Henry Ford Health System
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP