Overview

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