Modic trial: do osteoporosis therapies work for back pain?

Phase 3

Completed

• Conditions: Back pain; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12614000719639
• Lead Sponsor: niversity of Tasmania

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-08
• Study Completion: 2016-04-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 103

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified