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Parathyroid Hormone Derivative

Abaloparatide for Distal Femur Fractures

Phase 4
Waitlist Available
Led By Daniel Horwitz, MD
Research Sponsored by Daniel Horwitz
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is being treated for a closed supracondylar distal femur fracture with either a retrograde nail or locked plate
Subject is ≥ 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study Summary

This trial is testing whether a new compound, abaloparatide, can help heal supracondylar femur fractures better than a placebo.

Who is the study for?
This trial is for people aged 65 or older with a specific type of leg fracture (closed supracondylar distal femur fracture) who are undergoing surgery to fix it. They must be able to understand and sign the consent form in English, and their post-surgery x-rays should show proper alignment. Those with open fractures, other severe injuries, hypercalcemia, history of kidney stones, or conditions affecting healing aren't eligible.Check my eligibility
What is being tested?
The study tests Abaloparatide's ability to speed up bone healing against a placebo in elderly patients with certain leg fractures. It's randomized and double-blind: neither doctors nor patients know who gets the real treatment or placebo. Each group has 38 patients.See study design
What are the potential side effects?
While not specified here, similar treatments have been associated with increased bone mass but may include risks like high calcium levels in blood, dizziness upon injection site reactions, and possibly an increased risk of urinary stones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am being treated for a specific type of thigh bone fracture with surgery.
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I am 65 years old or older.
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I am having surgery to fix a broken bone with hardware.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
maintenance of axial alignment and loss of fixation
modified Radiographic Union Score for Tibia Fractures (mRUST)

Side effects data

From 2021 Phase 3 trial • 228 Patients • NCT03512262
13%
Injection site erythema
9%
Nasopharyngitis
9%
Dizziness
7%
Injection site swelling
7%
Arthralgia
6%
Injection site pain
5%
Upper respiratory tract infection
5%
Back pain
5%
Headache
5%
Bronchitis
5%
Hypertension
4%
Sinusitis
1%
Chronic obstructive pulmonary disease
1%
Peripheral nerve palsy
1%
Toxicity to various agents
1%
Angina unstable
1%
Supraventricular tachycardia
1%
Small intestinal obstruction
1%
Appendicitis
1%
Influenza
1%
Lung adenocarcinoma
1%
Cerebrovascular accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Abaloparatide

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Abaloparatide groupExperimental Treatment1 Intervention
Patients in the experimental group will receive abaloparatide after their surgery.
Group II: Control groupPlacebo Group1 Intervention
Patients in the control group will receive a placebo after their surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abaloparatide
2021
Completed Phase 3
~22310

Find a Location

Who is running the clinical trial?

Radius Health, Inc.Industry Sponsor
14 Previous Clinical Trials
27,151 Total Patients Enrolled
Daniel HorwitzLead Sponsor
Daniel Horwitz, MDPrincipal InvestigatorGeisinger Clinic

Media Library

Abaloparatide (Parathyroid Hormone Derivative) Clinical Trial Eligibility Overview. Trial Name: NCT04626141 — Phase 4
Femur Fractures Research Study Groups: Control group, Abaloparatide group
Femur Fractures Clinical Trial 2023: Abaloparatide Highlights & Side Effects. Trial Name: NCT04626141 — Phase 4
Abaloparatide (Parathyroid Hormone Derivative) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04626141 — Phase 4
~0 spots leftby Jun 2025
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