Intravenous bisphosphonate in stress fracture treatment

Intravenous bisphosphonate in stress fracture treatment -A randomised controlled double blinded multicenter trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004318-27-NO

Enrollment

Registered

2016-05-02

Start date

2016-08-31

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress fractures in the foot

Interventions

Trade Name: Aclasta Product Name: Aclasta / zoledronic acid Pharmaceutical Form: Injection Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intravenous use

Eligibility

Sex/Gender

All

Inclusion 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 3 -non-aided ambulatory patient prior to the injury Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

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 25 -pregnancy -breast feeding -hypocalcemia -MRI contraindications

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 12 months;Main Objective: We will evaluate 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. Primary outcome measure is change in the AOFAS ankle-hindfoot scale;Secondary Objective: -Change in VAS (pain) -Time to healing -Change in bone marrow lesions evaluated by MRI;Primary end point(s): Change in the AOFAS ankle-hindfoot scale	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 12 months;Main Objective: We will evaluate 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. Primary outcome measure is change in the AOFAS ankle-hindfoot scale;Secondary Objective: -Change in VAS (pain) -Time to healing -Change in bone marrow lesions evaluated by MRI;Primary end point(s): Change in the AOFAS ankle-hindfoot scale

—

Secondary

Measure	Time frame
Secondary end point(s): -Change in VAS (pain) -Time to healing -Change in bone marrow lesions evaluated by MRI;Timepoint(s) of evaluation of this end point: 12 months	—

Countries

Norway

Contacts

Public ContactDep. of Orthopaedic Surgery

Oslo University Hospital

4722118080

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026