Osteoarthritis
Conditions
Keywords
Osteoarthritis, intra articular steroids
Brief 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. 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
Interventions
DRUGMethylprednisolone and Lidocaine
Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
DRUGPlacebo and Lidocaine
Placebo and lidocaine 20 mg
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Osteocalcin | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Cortisol | Change from Baseline Visit to Day 28 | Cortisol levels were measured over 28 days. Outcome represents mean change in cortisol level between baseline visit and day 28. |
| Change in Testosterone | Change from Baseline Visit to Day 28 | Outcome represents the mean change in testosterone level from baseline visit to day 28. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 - Standard Dose Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg | 10 |
| Group 2 - Low Dose Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg | 10 |
| Group 3 - Placebo Placebo and Lidocaine: Placebo and lidocaine 20 mg | 5 |
| Total | 25 |
Baseline characteristics
| Characteristic | Group 1 - Standard Dose | Group 2 - Low Dose | Group 3 - Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 1 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 8 Participants | 4 Participants | 19 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 5 participants | 25 participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 4 Participants | 20 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 5 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 5 |
Outcome results
Primary
Change in Serum Osteocalcin
Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28.
Time frame: Change from Baseline Visit to Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 - Standard Dose | Change in Serum Osteocalcin | -2.18 ng/mL | Standard Deviation 2.24 |
| Group 2 - Low Dose | Change in Serum Osteocalcin | -0.45 ng/mL | Standard Deviation 2.9 |
| Group 3 - Placebo | Change in Serum Osteocalcin | -1.10 ng/mL | Standard Deviation 2.56 |
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.
Time frame: Change from Baseline Visit to Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 - Standard Dose | Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) | -0.153 U/L | Standard Deviation 0.457 |
| Group 2 - Low Dose | Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) | -0.295 U/L | Standard Deviation 0.472 |
| Group 3 - Placebo | Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) | -0.148 U/L | Standard Deviation 0.804 |
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.
Time frame: Change from Baseline Visit to Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 - Standard Dose | Change in Serum Cortisol | -1.16 mcg/dL | Standard Deviation 5.69 |
| Group 2 - Low Dose | Change in Serum Cortisol | 0.65 mcg/dL | Standard Deviation 4.59 |
| Group 3 - Placebo | Change in Serum Cortisol | 1.30 mcg/dL | Standard Deviation 1.75 |
Secondary
Change in Testosterone
Outcome represents the mean change in testosterone level from baseline visit to day 28.
Time frame: Change from Baseline Visit to Day 28
Population: Only males randomized to Group 1 - Standard Dose were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 - Standard Dose | Change in Testosterone | 0.08 ng/dL | Standard Deviation 0.28 |