To Assess the Changes in Markers of Bone Turnover Over a Six Month Period After Epidural Steroid InjectNCT00941473
Effect of Epidural Steroid Injection on Bone Mineral Density in Postmenopausal Women
An observational study of To Assess the Changes in Markers of Bone Turnover Over a Six Month Period After Epidural Steroid Inject and To Assess the Changes in Bone Mineral Density, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- 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
- What is being tested?
- Triamcinilone (kenalog)
- Type of treatment
- Injection or infusion
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants were recruited from an orthopedic spine clinic within a large metropolitan health system.
Who may be able to join
- Patients with low back pain and have consented to ESI. Age 55 and 5 years postmenopausal Caucasian women.
Who cannot join
- any women who doesn't meet the inclusion criteria
- Women with history of a disease affection bone turnover
- Women taking any drugs known to influence bone metabolism
- Women who had smoked within the preceding year
- Women with abnormal serum thyrotropin concentration, or high parathyroid hormone concentratons.
- 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
Show all 9Show fewer
- Women diagnosed with osteoporosis (T score<=2.5) on baseline DXA or had history of osteoportic fracture.
- Pregnant women
- Severe scoliosis -
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Hospital W. Bloomfield
West Bloomfield, Michigan, 48322
About this study
Official title: 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.
Read the 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
- Being tested
- Triamcinilone (kenalog)
- Keywords
- Epidural Injection, Bone Density
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinilone (kenalog)Drug
Epidural steroid injection of 80mg of Triamcinilone.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Triamcinilone (kenalog) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements will be taken at baseline and then repeated at 3,6, and 12 months after treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startJul 2007
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Assess the Changes in Markers of Bone Turnover Over a Six Month Period After Epidural Steroid InjectStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941473
- Sponsor's protocol ID
- J90067
- Other IDs
- IRB#4569, patient care #80211089
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2009
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Epidural Steroid Injection on Bone Mineral Density In Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00941473
- Acronym / sponsor ID
- J90067
- 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
- Keywords
- Epidural Injection, Bone Density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 17 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidural Steriod Injection | – | Drug: Triamcinilone (kenalog)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) |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants were recruited from an orthopedic spine clinic within a large metropolitan health system.
Key inclusion criteria (1 listed)
- Patients with low back pain and have consented to ESI. Age 55 and 5 years postmenopausal Caucasian women.
Key exclusion criteria (9 listed)
- any women who doesn't meet the inclusion criteria
- Women with history of a disease affection bone turnover
- Women taking any drugs known to influence bone metabolism
- Women who had smoked within the preceding year
- Women with abnormal serum thyrotropin concentration, or high parathyroid hormone concentratons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinilone (kenalog)Epidural steroid injection of 80mg of Triamcinilone. | Drug | Epidural Steriod Injection |
Primary outcome
Measurements will be taken at baseline and then repeated at 3,6, and 12 months after treatment.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Assess the Changes in Markers of Bone Turnover Over a Six Month Period After Epidural Steroid Inject and To Assess the Changes in Bone Mineral Density, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurements will be taken at baseline and then repeated at 3,6, and 12 months after treatment. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.