OsteoarthritisNCT00682357
Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis
A study testing Methylprednisolone and Lidocaine in people with Osteoarthritis, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Oral and nasal steroids may enhance osteoporosis by suppressing bone formation. Intra-articular steroids may also suppress bone formation, however, the duration or relationship to a steroid dose has not been established. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Methylprednisolone and Lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to May 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 40 years
- Male or postmenopausal female
- Diagnosis of knee osteoarthritis
- DEXA bone density done within the past 12 months
- Painful knee, visual analogue scale (VAS) > 4 of (10=worst)
Who cannot join
- Diabetes Mellitus Type I or II
- Systemic inflammatory illness
- Systemic infections which may be aggravated by steroid therapy
- No current or previous (< 3 years) biphosphate therapy
- Previous knee replacement surgery
- No current or previous Parathyroid hormone (PTH) therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Oral and nasal steroids may enhance osteoporosis by suppressing bone formation. Intra-articular steroids may also suppress bone formation, however, the duration or relationship to a steroid dose has not been established. It is hypothesized that intra-articular steroids suppress bone formation transiently, returning to pretreatment levels within four weeks in subjects with osteoarthritis.
Read the detailed description
Oral and nasal steroids may enhance osteoporosis by suppressing bone formation. Intra-articular steroids may also suppress bone formation, however, the duration or relationship to a steroid dose has not been established. It is hypothesized that intra-articular steroids suppress bone formation transiently, returning to pretreatment levels within four weeks in subjects with osteoarthritis. The purpose of the study is to determine if intra-articular steroids suppress markers of bone formation or resorption in osteoarthritis patients and whether these markers may be modified by Vitamin D or Dual-energy X-ray absorptiometry (DEXA) bone density status
- Conditions
- Osteoarthritis
- Being tested
- Methylprednisolone and Lidocaine, Placebo and Lidocaine
- Keywords
- Osteoarthritis, intra articular steroids
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone and LidocaineDrug
Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
Methylprednisolone and LidocaineDrug
Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
Placebo and LidocaineDrug
Placebo and lidocaine 20 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Methylprednisone 80 mg and Lidocaine 20 mg Receives: Drug: Methylprednisolone and Lidocaine |
| 2 | Experimental | Methylprednisolone 16 mg and Lidocaine 20 mg Receives: Drug: Methylprednisolone and Lidocaine |
| 3 | Placebo comparator | Placebo and Lidocaine 20 mg Receives: Drug: Placebo and Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Osteocalcin
Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28.
Measured: Change from Baseline Visit to Day 28
Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)
Outcome represents the mean change in serum biomarkers of bone breakdown (TRACP-5b) from baseline visit to day 28.
Measured: Change from Baseline Visit to Day 28
Secondary outcomes (2)
Change in Testosterone
Outcome represents the mean change in testosterone level from baseline visit to day 28.
Measured: Change from Baseline Visit to Day 28
Change in Serum Cortisol
Cortisol levels were measured over 28 days. Outcome represents mean change in cortisol level between baseline visit and day 28.
Measured: Change from Baseline Visit to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startMay 2008
- Primary completionNov 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herbert Lindsley, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682357
- Sponsor's protocol ID
- 11199
- Status last verified
- Aug 2024
- First submitted
- 20 May 2008
- Last updated
- 13 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis
- ClinicalTrials.gov ID
- NCT00682357
- Acronym / sponsor ID
- 11199
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, intra articular steroids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 22 May 2008 (estimated)
- Results
- Posted 29 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oral and nasal steroids may enhance osteoporosis by suppressing bone formation. Intra-articular steroids may also suppress bone formation, however, the duration or relationship to a steroid dose has not been established. It is hypothesized that intra-articular steroids suppress bone formation transiently, returning to pretreatment levels within four weeks in subjects with osteoarthritis.
Detailed description
Oral and nasal steroids may enhance osteoporosis by suppressing bone formation. Intra-articular steroids may also suppress bone formation, however, the duration or relationship to a steroid dose has not been established. It is hypothesized that intra-articular steroids suppress bone formation transiently, returning to pretreatment levels within four weeks in subjects with osteoarthritis. The purpose of the study is to determine if intra-articular steroids suppress markers of bone formation or resorption in osteoarthritis patients and whether these markers may be modified by Vitamin D or Dual-energy X-ray absorptiometry (DEXA) bone density status
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Methylprednisolone and LidocaineMethylprednisone 80 mg and Lidocaine 20 mg |
| 2 | Experimental | Drug: Methylprednisolone and LidocaineMethylprednisolone 16 mg and Lidocaine 20 mg |
| 3 | Placebo comparator | Drug: Placebo and LidocainePlacebo and Lidocaine 20 mg |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 40 years
- Male or postmenopausal female
- Diagnosis of knee osteoarthritis
- DEXA bone density done within the past 12 months
- Painful knee, visual analogue scale (VAS) > 4 of (10=worst)
Key exclusion criteria (6 listed)
- Diabetes Mellitus Type I or II
- Systemic inflammatory illness
- Systemic infections which may be aggravated by steroid therapy
- No current or previous (< 3 years) biphosphate therapy
- Previous knee replacement surgery
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 |
|---|---|---|
| Methylprednisolone and LidocaineMethylprednisolone 80 mg, intra-articular and lidocaine 20 mg | Drug | 1 |
| Methylprednisolone and LidocaineMethylprednisolone 16 mg intra-articular and lidocaine 20 mg | Drug | 2 |
| Placebo and LidocainePlacebo and lidocaine 20 mg | Drug | 3 |
Primary outcome
Change in Serum Osteocalcin
Time frame: Change from Baseline Visit to Day 28
Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28.
Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)
Time frame: Change from Baseline Visit to Day 28
Outcome represents the mean change in serum biomarkers of bone breakdown (TRACP-5b) from baseline visit to day 28.
2 secondary outcomes
Change in Testosterone
Time frame: Change from Baseline Visit to Day 28
Change in Serum Cortisol
Time frame: Change from Baseline Visit to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Herbert Lindsley, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylprednisolone and Lidocaine in people with Osteoarthritis, run by University of Kansas Medical Center 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 5 inclusion and 6 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 13 Aug 2024. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 29 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Serum Osteocalcin (time frame: Change from Baseline Visit to Day 28). The study lists 2 primary outcomes in all. 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 13 Aug 2024.