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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Methylprednisone 80 mg and Lidocaine 20 mg |
|
| 2 | Experimental | Methylprednisolone 16 mg and Lidocaine 20 mg |
|
| 3 | Placebo Comparator | Placebo and Lidocaine 20 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone and Lidocaine | Drug | Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Osteocalcin | Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28. | 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. | Change from Baseline Visit to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Testosterone | Outcome represents the mean change in testosterone level from baseline visit to day 28. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herbert Lindsley, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 - Standard Dose | Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg |
| FG001 | Group 2 - Low Dose | Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg |
| FG002 | Group 3 - Placebo | Placebo and Lidocaine: Placebo and lidocaine 20 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 - Standard Dose | Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg |
| BG001 | Group 2 - Low Dose | Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Serum Osteocalcin | Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28. | Posted | Mean | Standard Deviation | ng/mL | Change from Baseline Visit to Day 28 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 - Standard Dose | Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Herbert Lindsley | University of Kansas Medical Center | (913) 588-3402 | HLINDSLE@kumc.edu |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Methylprednisolone and Lidocaine |
| Drug |
Methylprednisolone 16 mg intra-articular and lidocaine 20 mg |
|
| Placebo and Lidocaine | Drug | Placebo and lidocaine 20 mg |
|
| Change from Baseline Visit to Day 28 |
| BG002 | Group 3 - Placebo | Placebo and Lidocaine: Placebo and lidocaine 20 mg |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo and Lidocaine: Placebo and lidocaine 20 mg
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | U/L | Change from Baseline Visit to Day 28 |
|
|
|
| Secondary | Change in Testosterone | Outcome represents the mean change in testosterone level from baseline visit to day 28. | Only males randomized to Group 1 - Standard Dose were included in this analysis. | Posted | Mean | Standard Deviation | ng/dL | Change from Baseline Visit to Day 28 |
|
|
|
| Secondary | Change in Serum Cortisol | Cortisol levels were measured over 28 days. Outcome represents mean change in cortisol level between baseline visit and day 28. | Posted | Mean | Standard Deviation | mcg/dL | Change from Baseline Visit to Day 28 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Group 2 - Low Dose | Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg | 0 | 10 | 0 | 10 |
| EG002 | Group 3 - Placebo | Placebo and Lidocaine: Placebo and lidocaine 20 mg | 0 | 5 | 0 | 5 |
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| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |