Intravenous bisphosphonate in stress fracture treatment

Phase 1

• Conditions: Stress fractures in the foot; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2014-004318-27-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-02
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 40

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): -Change in VAS (pain)<br> -Time to healing<br> -Change in bone marrow lesions evaluated by MRI<br> ;Timepoint(s) of evaluation of this end point: 12 months