Trials / Completed
CompletedNCT00941473
Effect of Epidural Steroid Injection on Bone Mineral Density in Postmenopausal Women
Effect of Epidural Steroid Injection on Bone Mineral Density In Postmenopausal Women
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Henry Ford Health System · Academic / Other
- Sex
- Female
- Age
- 55 Years – 80 Years
- Healthy volunteers
- Accepted
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Triamcinilone (kenalog) | Epidural steroid injection of 80mg of Triamcinilone. |
Timeline
- Start date
- 2007-07-01
- Primary completion
- 2011-07-01
- Completion
- 2011-07-01
- First posted
- 2009-07-17
- Last updated
- 2024-02-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00941473. Inclusion in this directory is not an endorsement.