Modic trial: do osteoporosis therapies work for back pain?

INTERVENTION: 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. CONDITION: Back pain PRIMARY OUTCOME: Back pain, as assessed using a 100mm visual analog score. Maximum size of Modic lesion (mm2), as assessed on MRI. ; SECONDARY OUTCOME: Back pain as assessed by questionnaire (the LBP Rating Scale) Disability, using the Roland Morris Disability Questionnaire Proportion with type 1 Modic changes over 6 months, as assessed on presence or absence of Modic changes visible on MRI. Safety assessed by monitoring and reporting any adverse events. Adverse events include any changes in the health of a participant and will be self‐reported. Participants will be asked to report any adverse events at 3 months (by questionnaire designed for this purpose) and 6 months (by interview). Participants will also be able to report events between clinic visits by telephoning the coordinator. Adverse events may include, for example, a reaction at the infusion / injection site, attendance at a hospital emergency department, hospitalisation. All adverse events will be reported to the Prinicpal Investigator at each site who will determine the relationship (or otherwise) to zoledronic acid or denosumab. Size of Modic lesion on an ordinal scale, using the Nordic Modic Consensus Group classification Utility, as assessed by the AQoL questionnaire. 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.