Intravenous bisphosphonate in stress fracture treatment

INTERVENTION: 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 CONDITION: Stress fractures in the foot Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: ; 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 Timepoint(s) of evaluation of this end point: 12 months SECONDARY OUTCOME: ; 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 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