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Osteoporosis Agent

Abaloparatide for Pelvic Fracture

Phase 2

Waitlist Available

Led By Jeri W Nieves, PhD

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

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.

Who is the study for?

This trial is for postmenopausal women and men over 50 with recent pelvic fractures from minimal trauma, treated at select New York hospitals. Exclusions include non-ambulatory individuals, those with certain cancers or kidney stones, hypercalcemia, hypersensitivity to Abaloparatide, or other metabolic bone diseases.Check my eligibility

What is being tested?

The study tests if Abaloparatide speeds up healing in pelvic fractures compared to a placebo. It's a double-blind test where neither doctors nor patients know who gets the real medicine. After three months of testing, everyone can choose to take Abaloparatide for nine more months.See study design

What are the potential side effects?

Possible side effects of Abaloparatide may include dizziness upon injection site reactions like redness or pain; increase in heart rate; nausea; fatigue; headache and possibly an increase in blood calcium levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Efficacy for fracture healing- Measured by participant cortical bridging scores

Secondary outcome measures

Efficacy measure of participant pain score as assessed by the Numeric Rating Scale

Efficacy measure of the time for participants to complete the Timed Up and Go Test.

Participant (percent) reporting narcotic use for pain

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: abaloparatide prefilled syringeActive Control1 Intervention

Abaloparatide-SC is supplied as a liquid, 3120 micrograms per 1.56 milliliter (2000 mcg/mL) in a single patient multi-use prefilled pen. The prefilled pen delivers 30 doses of abaloparatide, each containing 80 mcg of abaloparatide in 40 microliters of a sterile, clear, colorless solution. To be administered subcutaneously daily.

Group II: Placebo prefilled syringePlacebo Group1 Intervention

For the placebo-SC a prefilled multi-use pen injector cartridge is designed to deliver 30 doses of placebo each in 40 microliters of sterile, clear, colorless solution to be administered subcutaneously daily.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor

243 Previous Clinical Trials

59,316 Total Patients Enrolled

Weill Medical College of Cornell UniversityOTHER

1,054 Previous Clinical Trials

1,316,480 Total Patients Enrolled

Icahn School of Medicine at Mount SinaiOTHER

858 Previous Clinical Trials

524,238 Total Patients Enrolled

Media Library

Abaloparatide (Osteoporosis Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04249232 — Phase 2

Pelvic Fracture Research Study Groups: abaloparatide prefilled syringe, Placebo prefilled syringe

Pelvic Fracture Clinical Trial 2023: Abaloparatide Highlights & Side Effects. Trial Name: NCT04249232 — Phase 2

Abaloparatide (Osteoporosis Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04249232 — Phase 2

Frequently Asked Questions

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

Is it possible for new participants to enroll in this research at present?

"Affirmative. According to clinicaltrials.gov, this medical research venture is actively enrolling participants, with the first post appearing on September 17th 2020 and latest edit occuring on July 27th 2022. 78 subjects must be recruited from 5 separate trial sites."

Answered by AI

Are there any additional experiments that have been implemented using abaloparatide prefilled syringe?

"Currently, 7 active trials for abaloparatide prefilled syringe are in progress with none of them having reached Phase 3. 11 medical centres across the country are participating, predominately situated throughout New york City."

Answered by AI

How many individuals are being treated as part of this clinical investigation?

"Affirmative. According to clinicaltrials.gov, this experiment is actively looking for participants and has been since September 17th 2020 when it was first posted. 78 test subjects are being recruited from 5 different medical sites as of July 27th 2022, the date of its last edit."

Answered by AI