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

NCT03576599 | Terminated Phase 4

• 1 other identifier: REK 2014/1986
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress Fracture Foot; Stress Fracture Ankle

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 Product DRUG

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

Also known as: Aclasta

Zoledronic Acid Injectable Product

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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.
• at least 6 months of pain history
• compliant patient
• non-aided ambulatory patient prior to the injury

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Betanien Hospital: collaborator
• Sykehuset Ostfold: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0450, Norway

Location

MeSH Terms

Interventions

Zoledronic Acid

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Elisabeth E Husebye, PhD

  Oslo University Hospital

  STUDY CHAIR

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
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: September 13, 2019

Record last verified: 2018-07

Locations

NO (1)