A randomised controlled trial on the effect of zolendronic acid versus placebo on the amount of knee pain in patients with bone marrow oedema-associated knee pain.

Phase 2

Completed

• Conditions: Knee Pain; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12609000399291
• Lead Sponsor: Menzies Research Institue

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Knee Pain with bone marrow oedema on magnetic resonance imaging (MRI).

Exclusion Criteria

Any prior use of bisphosphonate preparations, except according to the washout schedule:
2 years (if use >48 weeks)
1 year (if used >8 weeks but <48 weeks)
6 months (if used >2 weeks but <8 weeks)
2 months (if used <2 weeks)
Any intravenous bisphosphonate within the prior 2 years,
History of iritis or uveitis, except due to trauma, and resolved for >2 years prior to study
Serum calcium >2.75 mmol/L (11.0 mg/dL) or <2.00 mmol/L (8.0 mg/dL)
Serum 25-hydroxyvitamin D concentrations <15 ng/L
Use of any investigational drug(s) and/or devices within 30 days prior to randomization
creatinine clearance < 35 ml/min
Metastatic cancer or cancer diagnosed less than 2 years ago where treatment is still ongoing
A dental exam with appropriate preventative dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, corticosteroids, poor hygiene)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Magnetic resonance imaging assesment of bone marrow lesions[6 months following the commencement of treatment]

Secondary Outcome Measures

Name	Time	Method
Knee pain as measured by visual analogue score and magnetic resonance imaging[6 months following the commencement of treatment];Knee Function, using a questionnaire: Knee injury and Osteoarthritis Outcome Score (KOOS).[3, 6 and 12 months following the commencement of treatment];Safety, using interview.[Each visit: 3, 6 and 12 months following the commencement of treatment]