Stress Fracture Ankle Clinical Trial
Official title:
Intravenous Bisphosphonate in Stress Fracture Treatment
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.
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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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06024798 -
Detecting and Assessing Leg and Foot Stress Fractures Using Photon Counting CT
|