Trials Sponsors Conditions Drugs Pricing

Conditions

Stress Fracture Ankle Stress Fracture Foot

Outcome Measures

Primary Outcomes (1)

The American Orthopedic Foot and Ankle Score (AOFAS) mid foot scale
a scale evaluating pain, function and alignment of the foot. 0-100, With 100 as maximum score
1 year

Secondary Outcomes (3)

Visual analoge scale (VAS) for pain
3, 6, 8, 10 and 12 months
Change in bone marrow lesions evaluated by magnetic resonance imaging (MRI)
1 year
The American Orthopedic Foot and Ankle Score (AOFAS) mid foot scale
3, 6, 8, 10, 12 months

Study Arms (2)

Zoledronic Acid Injectable Product

ACTIVE COMPARATOR

Patients randomized to treatment with Zoledronic Acid 5mg infusion, repeated after 3 months

Drug: Zoledronic Acid Injectable Product

Placebo

PLACEBO COMPARATOR

Patients randomized to Placebo infusion (saline), repeated after 3 months

Drug: Placebo

Interventions

Zoledronic Acid Injectable ProductDrug

One Group are randomiced to Zoledronic Acid Injectable Product and one Group to Placebo

Also known as: Aclasta

Zoledronic Acid Injectable Product

PlaceboDrug

Placebo

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0450, Norway

MeSH Terms

Interventions

Zoledronic Acid

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

Elisabeth E Husebye, PhD
Oslo University Hospital
STUDY CHAIR

Enrollment

5 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

June 22, 2018

First Posted

July 3, 2018

Study Start

June 29, 2017

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Zoledronic Acid Injectable Product

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Zoledronic Acid Injectable Product

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations