Trial Outcomes & Findings for Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis (NCT NCT00682357)

NCT ID: NCT00682357

Last Updated: 2024-08-13

Results Overview

Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: Change from Baseline Visit to Day 28
• Results posted on: 2024-08-13

Participant Flow

Participant milestones

Measure	Group 1 - Standard Dose Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg	Group 2 - Low Dose Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg	Group 3 - Placebo Placebo and Lidocaine: Placebo and lidocaine 20 mg
Overall Study STARTED	10	10	5
Overall Study COMPLETED	10	10	5
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis

Baseline characteristics by cohort

Measure	Group 1 - Standard Dose n=10 Participants Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg	Group 2 - Low Dose n=10 Participants Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg	Group 3 - Placebo n=5 Participants Placebo and Lidocaine: Placebo and lidocaine 20 mg	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	19 Participants n=4 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	20 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	5 participants n=5 Participants	25 participants n=4 Participants

PRIMARY outcome

Timeframe: Change from Baseline Visit to Day 28

Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28.

Outcome measures

Measure	Group 1 - Standard Dose n=10 Participants Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg	Group 2 - Low Dose n=10 Participants Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg	Group 3 - Placebo n=5 Participants Placebo and Lidocaine: Placebo and lidocaine 20 mg
Change in Serum Osteocalcin	-2.18 ng/mL Standard Deviation 2.24	-0.45 ng/mL Standard Deviation 2.90	-1.10 ng/mL Standard Deviation 2.56

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Group 1 - Standard Dose n=10 Participants Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg	Group 2 - Low Dose n=10 Participants Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg	Group 3 - Placebo n=5 Participants Placebo and Lidocaine: Placebo and lidocaine 20 mg
Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)	-0.153 U/L Standard Deviation 0.457	-0.295 U/L Standard Deviation 0.472	-0.148 U/L Standard Deviation 0.804

SECONDARY outcome

Timeframe: Change from Baseline Visit to Day 28

Population: Only males randomized to Group 1 - Standard Dose were included in this analysis.

Outcome represents the mean change in testosterone level from baseline visit to day 28.

Outcome measures

Measure	Group 1 - Standard Dose n=3 Participants Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg	Group 2 - Low Dose Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg	Group 3 - Placebo Placebo and Lidocaine: Placebo and lidocaine 20 mg
Change in Testosterone	0.08 ng/dL Standard Deviation 0.28	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Group 1 - Standard Dose n=10 Participants Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg	Group 2 - Low Dose n=10 Participants Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg	Group 3 - Placebo n=5 Participants Placebo and Lidocaine: Placebo and lidocaine 20 mg
Change in Serum Cortisol	-1.16 mcg/dL Standard Deviation 5.69	0.65 mcg/dL Standard Deviation 4.59	1.30 mcg/dL Standard Deviation 1.75

Adverse Events

Group 1 - Standard Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2 - Low Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 3 - Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Herbert Lindsley

University of Kansas Medical Center

Phone: (913) 588-3402

Email: HLINDSLE@kumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place