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

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ClinicalTrials.gov Identifier: NCT03576599
Recruitment Status : Recruiting
First Posted : July 3, 2018
Last Update Posted : July 6, 2018
Sponsor:
Collaborators:
Betanien Hospital
Sykehuset Ostfold
Information provided by (Responsible Party):
Elisabeth Ellingsen Husebye, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Stress Fracture Foot Stress Fracture Ankle Drug: Zoledronic Acid Injectable Product Drug: Placebo Phase 4

Detailed Description:

Randomised controlled multicenter trial. Prospective study. The trial will be performed in accordance with the CONSORT-statement. The inclusion period will be two years. The patients will be randomised to standard treatment (casting, partial weight-bearing, orthotic insoles) in addition to either zoledronic acid or placebo (saline) infusions. The randomization process will be carried out through a web based randomization service (Norwegian University of Science and Technology, Unit for applied clinical research). Patient data will be kept and organized by a study coordinator (nurse) and will not be revealed for the clincal investigators, except in medical emergency situations. In such cases, the patient will be excluded from the study. A number of bottles containing zoledronic acid or placebo will be available in each of the participating hospitals. The bottles containing zoledronic acid and placebo are visually identical, numbered from 1 through 80 (two bottles with similar number, the second bottle will be kept for the second infusion). The patients will be randomised in blocks, creating evenly sized groups given zoledronic acid or placebo. When a patient is included and thereafter randomised, the study coordinator decides which bottle number to be given and provides this information to the physician. The study coordinator is the only person in the study group which is not blinded.

On the first visit, the included patients will undergo clinical examination and baseline parameters will be registered. If MRI is not previously obtained, this will be performed as quickly as possible. The clinical controls will be scheduled 4 and 12 and 26 weeks thereafter, the latter including MRI. If healing has still not occured, the patients will be given the second infusion and meet for clinical examination every 4 weeks until healing. Clinical healing is defined as painless or near painless (VAS pain 0-2) weight bearing. If healing has not occured 12 months after inclusion, surgery will be considered.

MRI will be obtained at (or before) baseline, 6 months and one year. MRIs will be examined by a blinded radiologist. Bone marrow lesions (BMLs) will be measured (area and volume) and fracture lines registered.

All patients (both groups) will be prescribed calcium and vitamin D (Calcigran Forte 500mg/400IE) taken orally once daily in the whole study period. This is recommended as an adjunct to bisphosphonate treatment on a general basis/standard treatment and is not to be investigated separately.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Bisphosphonate in Stress Fracture Treatment
Actual Study Start Date : June 29, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Zoledronic Acid Injectable Product
Patients randomized to treatment with Zoledronic Acid 5mg infusion, repeated after 3 months
Drug: Zoledronic Acid Injectable Product
One Group are randomiced to Zoledronic Acid Injectable Product and one Group to Placebo
Other Name: Aclasta

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




Primary Outcome Measures :
  1. The American Orthopedic Foot and Ankle Score (AOFAS) mid foot scale [ Time Frame: 1 year ]
    a scale evaluating pain, function and alignment of the foot. 0-100, With 100 as maximum score


Secondary Outcome Measures :
  1. Visual analoge scale (VAS) for pain [ Time Frame: 3, 6, 8, 10 and 12 months ]
    Patient Reported Outcome Measure (PROM) for evaluating local pain

  2. Change in bone marrow lesions evaluated by magnetic resonance imaging (MRI) [ Time Frame: 1 year ]
    the intensity and the amount of bone marrow oedema is evaluated

  3. The American Orthopedic Foot and Ankle Score (AOFAS) mid foot scale [ Time Frame: 3, 6, 8, 10, 12 months ]
    a scale evaluating pain, function and alignment of the foot



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • non-aided ambulatory patient prior to the injury

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03576599


Contacts
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Contact: Husebye, PhD 00 47 95133773 uxngng@ous-hf.no
Contact: Torben Ianssen, MD 00 47 93086500 torben.ianssen@gmail.com

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0450
Contact: Elisabeth E Husebye, MD, PhD    0047 95133773    uxngng@ous-hf.no   
Contact: Torben Ianssen, MD    0047 93086500    torben.ianssen@gmail.com   
Principal Investigator: Elisabeth E Husebye, MD, PhD         
Sponsors and Collaborators
Oslo University Hospital
Betanien Hospital
Sykehuset Ostfold
Investigators
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Study Chair: Elisabeth E Husebye, PhD Oslo University Hospital

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Responsible Party: Elisabeth Ellingsen Husebye, Principal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03576599     History of Changes
Other Study ID Numbers: REK 2014/1986
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Stress
Wounds and Injuries
Zoledronic Acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs