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OpenTrials
Completed

NCT Number: NCT00682357

Effect of Intraarticular Steroids on Bone Turnover in 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.

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

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. 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylprednisolone and Lidocaine

Drug

Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg

Placebo and Lidocaine

Drug

Placebo and lidocaine 20 mg

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in Testosterone

    Time frame: Change from Baseline Visit to Day 28

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

  2. Change in Serum Cortisol

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
May 22, 2008
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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