Intravenous Bisphosphonate in Stress Fracture Treatment -A Randomised Controlled Double Blinded Multicenter Trial

• Status: Terminated
• Trial end date: 2019-06-26
• Target enrollment: 0
• Participant gender: All

Summary

The effect of an intravenous bisphosphonate (zoledronic acid) on healing and symptoms of stress fractures that do not respond to conservative/conventional treatment within 6 months, will be investigated.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oslo University Hospital
• Collaborators: Betanien Hospital; Sykehuset Ostfold
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• Age 18-70 years

• Stress fractures in the foot. A stress fracture is defined as a fracture occured after repetitive trauma, with characteristic MRI findings (ref) and distinctive pain over the fracture site at weight bearing.

• at least 6 months of pain history

• compliant patient

• non-aided ambulatory patient prior to the injury

Exclusion Criteria:

• Ongoing use of bisphosphonates, PTH/PTH-analogues or use within 12 months prior to the injury

• Use of bisphophonates for more than 6 months within the last 5 years

• Intolerance to zoledronic acid

• Renal failure (GFR<30)

• S-25(OH)vitD > 25

• pregnancy

• breast feeding

• hypocalcemia

• MRI contraindications