A randomised trial of zoledronic acid for osteoarthritis of the knee

Phase 3

Completed

• Conditions: Knee pain; Knee osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12613000039785
• Lead Sponsor: Menzies Research Institute Tasmania, University of Tasmania

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

1) Males and females with significant knee pain on most days (defined as a pain score >= 40 mm on a 100-mm visual analogue scale (VAS)).

2) Aged >= 50 years old.

3) Bone marrow lesions present on MRI.

4) Meeting the American College of Rheumatology (ACR) criteria for symptomatic knee osteoarthritis.

Exclusion Criteria

1)Prior use of bisphosphonates, 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 IV bisphosphonate within the prior 2 years

2)History of non-traumatic iritis or uveitis

3)Abnormal blood tests [serum calcium >2.75 mmol/L (11.0 mg/dL) or <2.00 mmol/L (8.0 mg/dL) or creatinine clearance < 35 ml/min]

4)Serum 25-hydroxyvitamin D concentrations <40 nmol/L

5)Use of any investigational drug(s) and/or devices within 30 days or 5 half-lives (whichever is longer) of the drug prior to randomisation

6)Prior diagnosis of cancer (metastatic cancer or cancer diagnosed < 2 years ago where treatment is still ongoing)

7)Poor dental fitness: 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)

8)Severe knee osteoarthritis (joint space narrowing (JSN)) on X-ray of Grade 3 using the Osteoarthritis Research Society International (OARSI) atlas)

9)Other forms of arthritis in which disease is active and concomitant medication is used (e.g. rheumatoid arthritis or other inflammatory arthritis)

10)Patients who have undergone arthroscopy or open surgery in the index knee in the last 12 months

11)Women who are pregnant or breast feeding

12)Patients who have had a corticosteroid injection in the last 3 months or a hyaluronic acid injection in the last 6 months in the index knee

13)Planned joint replacement surgery

14)Contraindication to MRI scanning (for example, implanted pacemaker, metal sutures, presence of shrapnel or iron filings in the eye, claustrophobia, knee too large for coil)

15)Inability to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Magnetic resonance imaging assessment of cartilage volume loss[24 months following commencement of treatment]

Secondary Outcome Measures

Name	Time	Method
Knee pain as measured by visual analogue score and WOMAC[3, 6, 12, 18, and 24 months following the commencement of treatment ];Magnetic resonance imaging assessment of bone marrow lesions[6 and 24 months following commencement of treatment ]