ClinicalTrials.Veeva

Menu

Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis

University of Kansas logo

University of Kansas

Status

Completed

Conditions

Osteoarthritis

Treatments

Drug: Placebo and Lidocaine
Drug: Methylprednisolone and Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT00682357
11199 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment

25 patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

25 participants in 3 patient groups, including a placebo group

1
Experimental group
Description:
Methylprednisone 80 mg and Lidocaine 20 mg
Treatment:
Drug: Methylprednisolone and Lidocaine
Drug: Methylprednisolone and Lidocaine
2
Experimental group
Description:
Methylprednisolone 16 mg and Lidocaine 20 mg
Treatment:
Drug: Methylprednisolone and Lidocaine
Drug: Methylprednisolone and Lidocaine
3
Placebo Comparator group
Description:
Placebo and Lidocaine 20 mg
Treatment:
Drug: Placebo and Lidocaine

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems