FracturesPhase 4NCT01173081
The Use of Teriparatide as an Adjunctive Therapy for the Treatment of Jones Fractures
A Phase 4 study testing Teriparatide in people with Fractures, run by Ohio Orthopedic Center of Excellence at 1 site in United States.
Trial summary
This randomized, placebo-controlled study will evaluate the effectiveness of the adjunctive use of teriparatide for the healing of Jones fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractures
- What is being tested?
- Teriparatide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Apr 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are at least 18 years of age and who have closed epiphyses.
- Patients of both genders and all races.
- Patients with Jones fractures of the fifth metatarsal less than 2 weeks prior to presenting for clinical evaluation.
- Patients with a history of an acute injury and an acute Jones fracture defined by Torg et al as a fracture line with sharp margins without widening, absence of intramedullary sclerosis, and minimal or no cortical hypertrophy or evidence of periosteal changes due to chronic stress.
- Patients with either no prodromal symptoms or prodromal symptoms present less than 2 weeks.
- Patients with a baseline visual analog scale (VAS) pain score ≤ 20 (100mm scale) for the fifth metatarsal, with the foot at rest and not bearing weight.
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- Patients who are in good general health and who have physical examinations that either are within normal limits or are clinically non-significant as determined by the investigator.
- Patients with laboratory evaluations that either are within normal limits or are clinically non-significant as determined by the investigator.
- Patients who have voluntarily signed informed consent forms, including HIPAA Authorization.
Who cannot join
- Patients who are younger than 18 years of age or patients who are 18 years of age or older with open epiphyses.
- Patients with Jones fractures of the fifth metatarsal greater than 2 weeks prior to presenting for clinical evaluation.
- Patients with tuberosity avulsion fractures or fifth metatarsal shaft fractures.
- Patients with prior fifth metatarsal fracture(s).
- Patients with prodromal symptoms present for more than 2 weeks.
- Patients with a nonunion or delayed union as defined by the radiographic criteria described by Torg et al.
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- Patients who are allergic to any of the individual active ingredients in teriparatide or related compounds.
- Patients with chronic rheumatologic disease, ankylosing spondylitis or other inflammatory arthropathy.
- Patients with associated injuries considered by the investigator as to likely interfere with evaluation of the study drug.
- Patients with a present condition or history of any clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematologic, endocrine, neurologic, psychiatric, connective tissue, respiratory or other medical disorders.
- Patients with Worker's Compensation claim(s) under dispute or mediation.
- Patients with history of drug or alcohol abuse.
- Patients who are pregnant or lactating.
- Patients who are considered by the investigator for any reason to be an unsuitable candidate for receipt of the study drug.
- Patients who are unwilling or unable to follow the follow-up evaluation schedules.
- Patients who refuse to voluntarily sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ohio Orthopedic Center of Excellence
Upper Arlington, Ohio, 43220
Lindsay Arnott, BS, 614-827-8375, LArnott@ohio-ortho.com
Peter H. Edwards, Jr., MD
About this study
This randomized, placebo-controlled study will evaluate the effectiveness of the adjunctive use of teriparatide for the healing of Jones fractures.
- Conditions
- Fractures
- Being tested
- Teriparatide, Placebo
- Keywords
- Jones fracture, fifth metatarsal fracture, teriparatide, fracture healing
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Also called Forteo
20mcg once daily for 16 weeks or until study endpoint is achieved.
PlaceboDrug
matching dose of 20mcg of placebo once daily for 16 weeks or until study endpoint is achieved
| Study group | Role | What they receive |
|---|---|---|
| Teriparatide | Experimental | Patients randomized into this group will inject 20mcg of teriparatide once daily for 16 weeks or until the study endpoint is achieved. Additionally, patients will take oral calcium (1,000mg) and vitamin D3 (1,000 IU) supplements daily. Receives: Drug: Teriparatide |
| Placebo Control | Placebo comparator | Patients randomized into this group will inject a matching dose of placebo once daily for 16 weeks or until the study endpoint is achieved. Additionally, patients will take oral calcium (1,000mg) and vitamin D3 (1,000 IU) supplements daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture healing
Measured: weeks 4 through 24 after start of treatment
Secondary outcomes (4)
Pain
Measured: weeks 4 through 24 after start of treatment
Range of Motion
Measured: weeks 4 through 24 after start of treatment
Function
Measured: weeks 4 through 24 after start of treatment
Return to Activity
Measured: weeks 4 through 24 after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FracturesStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio Orthopedic Center of Excellence
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Peter H. Edwards, Jr., MD, Principal investigator, Ohio Orthopedic Center of Excellence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173081
- Sponsor's protocol ID
- B3D-US-X026
- Status last verified
- Jun 2012
- First submitted
- 28 Jul 2010
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Teriparatide as an Adjunctive Therapy for the Treatment of Jones Fractures
- ClinicalTrials.gov ID
- NCT01173081
- Acronym / sponsor ID
- B3D-US-X026
- Conditions
- Fractures
- Keywords
- Jones fracture, fifth metatarsal fracture, teriparatide, fracture healing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Ohio Orthopedic Center of ExcellenceUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Jul 2010
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 30 Jul 2010 (estimated)
- 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.
This randomized, placebo-controlled study will evaluate the effectiveness of the adjunctive use of teriparatide for the healing of Jones fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teriparatide | Experimental | Drug: TeriparatidePatients randomized into this group will inject 20mcg of teriparatide once daily for 16 weeks or until the study endpoint is achieved. Additionally, patients will take oral calcium (1,000mg) and vitamin D3 (1,000 IU) supplements daily. |
| Placebo Control | Placebo comparator | Drug: PlaceboPatients randomized into this group will inject a matching dose of placebo once daily for 16 weeks or until the study endpoint is achieved. Additionally, patients will take oral calcium (1,000mg) and vitamin D3 (1,000 IU) supplements daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who are at least 18 years of age and who have closed epiphyses.
- Patients of both genders and all races.
- Patients with Jones fractures of the fifth metatarsal less than 2 weeks prior to presenting for clinical evaluation.
- Patients with a history of an acute injury and an acute Jones fracture defined by Torg et al as a fracture line with sharp margins without widening, absence of intramedullary sclerosis, and minimal or no cortical hypertrophy or evidence of periosteal changes due to chronic stress.
- Patients with either no prodromal symptoms or prodromal symptoms present less than 2 weeks.
Key exclusion criteria (16 listed)
- Patients who are younger than 18 years of age or patients who are 18 years of age or older with open epiphyses.
- Patients with Jones fractures of the fifth metatarsal greater than 2 weeks prior to presenting for clinical evaluation.
- Patients with tuberosity avulsion fractures or fifth metatarsal shaft fractures.
- Patients with prior fifth metatarsal fracture(s).
- Patients with prodromal symptoms present for more than 2 weeks.
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 |
|---|---|---|
| TeriparatideAlso: Forteo20mcg once daily for 16 weeks or until study endpoint is achieved. | Drug | Teriparatide |
| Placebomatching dose of 20mcg of placebo once daily for 16 weeks or until study endpoint is achieved | Drug | Placebo Control |
Primary outcome
Fracture healing
Time frame: weeks 4 through 24 after start of treatment
4 secondary outcomes
Pain
Time frame: weeks 4 through 24 after start of treatment
Range of Motion
Time frame: weeks 4 through 24 after start of treatment
Function
Time frame: weeks 4 through 24 after start of treatment
Return to Activity
Time frame: weeks 4 through 24 after start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2012.
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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.
Peter H. Edwards, Jr., MD principal investigator
Ohio Orthopedic Center of Excellence
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 Teriparatide in people with Fractures, run by Ohio Orthopedic Center of Excellence at 1 site in United States.
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 9 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 5 Jun 2012. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter H. Edwards, Jr., MD (614-827-8700, LArnott@ohio-ortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture healing (time frame: weeks 4 through 24 after start of treatment). 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 5 Jun 2012.