Modic trial: do osteoporosis therapies work for back pain?

Effect of zoledronic acid or denosumab on Modic-change related back pain.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000719639

Acronym

Modic

Enrollment

103

Registered

2014-07-08

Start date

2014-11-14

Completion date

2015-10-31

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

This study aims to determine whether zoledronic acid or denosumab are efficacious in reducing back pain and size of Modic lesions in persons with back pain and Modic changes. Primary hypothesis is that either drug will be different to placebo for pain and size of Modic lesion at 6 months. The design is a double-blind placebo-controlled trial. Participants will be randomised to receive zoledronic acid or denosumab or placebo, and will be observed for 6 months.

Interventions

Zoledronic acid 5mg in 100ml saline given by intravenous infusion OR denosumab 60mg in 1ml subcutaneous injection. Participants receive two needles in a double dummy approach, receiving zoledronic acid (IV) and saline placebo (subcutaneous injection) OR saline (IV) and denosumab (subcutaneous injection) OR saline in both IV and subcutaneous injection. Intervention is only given once.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

Back pain primarily due to Modic changes visible on MRI. Back pain >40 on 100mm VAS. Aged >40 years. Modic changes type 1 must be present in at least one vertebrae (L1-L5 or upper endplate of S1). Participants must be able and willing to provide written informed consent and to comply with the requirements of the study.

Exclusion criteria

Prior use of bisphosphonates, except according to a washout schedule Prior use of denosumab Contra-indications to use of zoledronic acid or denosumab: history of non-traumatic iritis or uveitis, abnormal blood tests [serum calcium >2.75 mmol/L (11.0 mg/dL) or <2.00 mmol/L (8.0 mg/dL) or creatinine < 35 ml/min], serum 25-hydroxyvitamin D concentrations < 40 nmol/L (such participants can receive vitamin D supplementation prior to study entry), particiant is pregnant, breastfeeding, or planning to become pregnant. Female participants who are able to conceive will be required to use adequate contraception. Use of any investigational drug(s) and/or devices within 30 days prior to randomisation Prior diagnosis of cancer (metastatic cancer or cancer diagnosed < 2 years ago where treatment is still ongoing) Poor dental fitness: Persons will be excluded from the study if they have had recent dental injuries (implants / extractions) or are aware of the need for dental work (implants / extractions) in the near future (next 6–12 months) or have poor oral health (eg gum disease). Regular use of high doses of opiate pain medication (equivalent to oxycontin greater than or equal to 80mg/day) Diagnosis of chronic widespread pain including fibromyalgia or any other centrally mediated pain phenotype. Leg pain is of a greater severity than back pain Prior back surgery The participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Outcome results