E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stress fractures in the foot |
Stressfrakturer i foten |
|
E.1.1.1 | Medical condition in easily understood language |
Stress fractures in the foot |
Stressbrudd i foten |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. Primary outcome measure is change in the AOFAS ankle-hindfoot scale |
Vi vil undersøke effekten av intravenøst bisfosfonat (zoledronsyre) med tanke på tilheling og symptomer ved stressfrakturer som ikke responderer på konvensjonell behandling innen 6 måneder. Primært endepunkt er endring i AOFAS ankel-hindfoot scale. |
|
E.2.2 | Secondary objectives of the trial |
-Change in VAS (pain) -Time to healing -Change in bone marrow lesions evaluated by MRI |
-Endring i VAS smerte -Tid til tilheling -Endring i benmargslesjoner evaluert med MR |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
-Alder 18-70 år -Stressfraktur i foten definert ved karakteristiske kliniske- og MR-funn -Minst 6 mnd sykehistorie -Pasient med god compliance -gående uten støtte forut for skaden |
|
E.4 | Principal 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 |
-Pågående bruk av bisfosfonat/PTH analog, eller bruk siste 12 mnd før skaden -bruk av bisfosfonat i mer enn 6 mnd siste 5 år -intoleranse for zoledronsyre -nyresvikt (GFR<30) -S-25(OH)vitD > 25 -graviditet -amming -hypocalcemi -MR-kontraindikasjoner |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in the AOFAS ankle-hindfoot scale |
Endring i AOFAS-scale |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
-Change in VAS (pain) -Time to healing -Change in bone marrow lesions evaluated by MRI |
-Endring i VAS smerte -Tid til tilheling -Endring i benmargslesjoner evaluert med MR |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Siste undersøkelse av siste pasient |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |