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Teriparatide 20 mcg daily for Femoral Fracture

Phase 3
Waitlist Available
Led By Lianne E Tile, Md, MEd
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Atraumatic or low trauma incomplete stress fractures, defined as fractures sustained with minimal force, such as a fall from standing height;
From distal to the lesser trochanter to proximal to the supracondylar flare along the femoral shaft.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months
Awards & highlights

Study Summary

This trial will examine whether the osteoporosis medication teriparatide can help accelerate fracture healing and prevent surgical intervention in patients with an incomplete atypical femur fracture.

Eligible Conditions
  • Femoral Fracture

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the modified The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)of the affected limb (the femur that has the incomplete AFF)
The proportion of patients requiring surgical intervention

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Teriparatide 20 mcg dailyActive Control1 Intervention
Teriparatide (Forteo) 20 mcg daily by injection pen for 12-24 months
Group II: PlaceboPlacebo Group1 Intervention
Placebo injection pen identical to active drug injection pen

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor
2,605 Previous Clinical Trials
3,199,598 Total Patients Enrolled
University Health Network, TorontoLead Sponsor
1,461 Previous Clinical Trials
483,311 Total Patients Enrolled
The Physicians' Services Incorporated FoundationOTHER
162 Previous Clinical Trials
26,721 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What have been the findings regarding the safety of Teriparatide 20 mcg daily thus far?

"There is some evidence for efficacy and multiple rounds of safety data, so our team at Power rated Teriparatide 20 mcg daily as a 3 on the safety scale."

Answered by AI

Would patients who are over the age of 45 be applicable to enroll in this research project?

"This particular clinical trial only allows patients that are between the ages of 30 and 100 to enroll. If a patient is outside of that age bracket, there are 70 other trials for patients under 18 and 322 for patients over the age of 65."

Answered by AI

Is this an innovative clinical trial?

"Research on Teriparatide 20 mcg daily began in 2013 with an initial clinical trial sponsored by Eli Lilly and Company. Since the first study, which included 34 participants, Teriparatide 20 mcg daily received Phase 3 drug approval in 2013. There are currently 13 live studies involving Teriparatide 20 mcg daily across 7 cities and 9 countries."

Answered by AI

Who does this research include in its sample size?

"This study requires 34 participants, aged 30 to 100, who currently have fractures. The fractures must be classified as 'atraumatic or low trauma incomplete stress fractures', which means they were sustained with minimal force, such as a fall from standing height. Additionally, the fractures must be located on the femoral shaft from the distal lesser trochanter to the proximal supracondylar flare."

Answered by AI

Has Teriparatide 20 mcg daily been rigorously tested in other research trials?

"There are currently 13 Teriparatide 20 mcg daily studies underway, 1 of which is in Phase 3. The great majority of these trials are based in Lexington, Kentucky, but there are a total of 40 clinical trial sites for this medication."

Answered by AI

Are individuals still being sought for participation in this clinical trial?

"Although this particular trial is not recruiting patients at this time, it's possible to find other trials seeking participants on clinicaltrials.gov. According to the website, the most recent update for this trial was on September 28th, 2020."

Answered by AI
~3 spots leftby Mar 2025