abaloparatide prefilled syringe for Pelvic Fracture

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Pelvic FractureAbaloparatide 80 micrograms per Pen dose - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether the drug abaloparatide can help heal fractures in postmenopausal women and men over 50. The study will last for 3 months, with participants taking either the drug or a placebo. The trial will be extended for 9 months to see if there are any differences between the groups.

Eligible Conditions
  • Pelvic Fracture

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 12 months

12 months
Efficacy measure of participant pain score as assessed by the Numeric Rating Scale
Participant lower extremity function based on a score from the Continuous Summary Physical Performance Score. The measure of lower extremity physical function is an efficacy variable.
3 months
Efficacy for fracture healing- Measured by participant cortical bridging scores
Efficacy measure of the time for participants to complete the Timed Up and Go Test.
8 weeks
Participant (percent) reporting narcotic use for pain

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

abaloparatide prefilled syringe
1 of 2
Placebo prefilled syringe
1 of 2

Active Control

Non-Treatment Group

78 Total Participants · 2 Treatment Groups

Primary Treatment: abaloparatide prefilled syringe · Has Placebo Group · Phase 2

Placebo prefilled syringe
Drug
PlaceboComparator Group · 1 Intervention: Placebo prefilled injector pen · Intervention Types: Drug
abaloparatide prefilled syringe
Drug
ActiveComparator Group · 1 Intervention: Abaloparatide 80 micrograms per Pen dose · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Weill Medical College of Cornell UniversityOTHER
990 Previous Clinical Trials
1,339,291 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiOTHER
780 Previous Clinical Trials
483,052 Total Patients Enrolled
New York UniversityOTHER
205 Previous Clinical Trials
313,686 Total Patients Enrolled
Hospital for Special Surgery, New YorkLead Sponsor
225 Previous Clinical Trials
60,676 Total Patients Enrolled
Westchester Medical CenterOTHER
6 Previous Clinical Trials
623 Total Patients Enrolled
Joseph Lane, MDPrincipal InvestigatorHospital for Special Surgery, New York
Jeri W Nieves, PhDPrincipal InvestigatorHospital for Special Surgery, New York
1 Previous Clinical Trials
35 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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References