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.

Patients with bone marrow oedema-associated knee pain, randomised to zolendronic acid or placebo, assessed by the amount of knee pain after three and twelve months.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000399291

Acronym

ZAP1

Enrollment

Registered

2009-06-02

Start date

2009-07-10

Completion date

2010-12-10

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Study rationale: Bone marrow oedema has recently been recognized to be a key correlate of knee pain. There is no known treatment for this problem but it is very common in those over 50 (30% of a random sample of 50-80 year olds in Hobart) (Zhai, 2006). There are no randomized trials but there is some observational evidence suggesting bisphosphonates modify this process. Firstly, they are much less common in population samples using bisphosphonates (OR 0.1) (Carbone 2004) and an open label study with IV ibandronate led to rapid resolution of hip bone marrow oedema (Ringe 2004) when natural history studies in the knee do not suggest resolution. Zoledronic acid is an attractive candidate for the treatment of this condition dues to its one off administration and potential for long term efficacy

Interventions

Once-off intravenous infusion of 5mg zolendronic acid

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

50 Years to 100 Years

Healthy volunteers

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)

Outcome results