Stress Fracture FootPhase 4NCT03576599
Intravenous Bisphosphonate in Stress Fracture Treatment -A Randomised Controlled Double Blinded Multicenter Trial
A Phase 4 study testing Zoledronic Acid Injectable Product in people with Stress Fracture Foot and Stress Fracture Ankle, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Fracture Foot, Stress Fracture Ankle
- What is being tested?
- Zoledronic Acid Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteNorway
- Study dates
- 29 Jun 2017to 26 Jun 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- breast feeding
- hypocalcemia
- MRI contraindications
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stress Fracture Foot, Stress Fracture Ankle
- Being tested
- Zoledronic Acid Injectable Product, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic Acid Injectable ProductDrug
Also called Aclasta
One Group are randomiced to Zoledronic Acid Injectable Product and one Group to Placebo
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Zoledronic Acid Injectable Product | Active comparator | Patients randomized to treatment with Zoledronic Acid 5mg infusion, repeated after 3 months Receives: Drug: Zoledronic Acid Injectable Product |
| Placebo | Placebo comparator | Patients randomized to Placebo infusion (saline), repeated after 3 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
Visual analoge scale (VAS) for pain
Patient Reported Outcome Measure (PROM) for evaluating local pain
Measured: 3, 6, 8, 10 and 12 months
Change in bone marrow lesions evaluated by magnetic resonance imaging (MRI)
the intensity and the amount of bone marrow oedema is evaluated
Measured: 1 year
The American Orthopedic Foot and Ankle Score (AOFAS) mid foot scale
a scale evaluating pain, function and alignment of the foot
Measured: 3, 6, 8, 10, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start29 Jun 2017
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
Why it stopped: difficult to include patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Fracture FootStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Betanien Hospital, Sykehuset Ostfold
- Responsible party
- Principal investigator, Elisabeth Ellingsen Husebye, Oslo University Hospital
- Investigators
- Elisabeth E Husebye, PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576599
- Sponsor's protocol ID
- REK 2014/1986
- Status last verified
- Jul 2018
- First submitted
- 22 Jun 2018
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Bisphosphonate in Stress Fracture Treatment
- ClinicalTrials.gov ID
- NCT03576599
- Acronym / sponsor ID
- REK 2014/1986
- Conditions
- Stress Fracture Foot, Stress Fracture Ankle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficult to include patients
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Betanien Hospital, Sykehuset Ostfold
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 3 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zoledronic Acid Injectable Product | Active comparator | Drug: Zoledronic Acid Injectable ProductPatients randomized to treatment with Zoledronic Acid 5mg infusion, repeated after 3 months |
| Placebo | Placebo comparator | Drug: PlaceboPatients randomized to Placebo infusion (saline), repeated after 3 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic Acid Injectable ProductAlso: AclastaOne Group are randomiced to Zoledronic Acid Injectable Product and one Group to Placebo | Drug | Zoledronic Acid Injectable Product |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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
3 secondary outcomes
Visual analoge scale (VAS) for pain
Time frame: 3, 6, 8, 10 and 12 months
Change in bone marrow lesions evaluated by magnetic resonance imaging (MRI)
Time frame: 1 year
The American Orthopedic Foot and Ankle Score (AOFAS) mid foot scale
Time frame: 3, 6, 8, 10, 12 months
Results and safety
The study was stopped early (reason given: difficult to include patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth E Husebye, PhD study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zoledronic Acid Injectable Product in people with Stress Fracture Foot and Stress Fracture Ankle, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: difficult to include patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The American Orthopedic Foot and Ankle Score (AOFAS) mid foot scale (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.