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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 belowSelect...
I am being treated for a specific type of thigh bone fracture with surgery.
Select...
I am 65 years old or older.
Select...
I am having surgery to fix a broken bone with hardware.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
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 • NCT0351226213%
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
2018
Completed Phase 3
~260
Find a Location
Who is running the clinical trial?
Radius Health, Inc.Industry Sponsor
14 Previous Clinical Trials
21,097 Total Patients Enrolled
Daniel HorwitzLead Sponsor
Daniel Horwitz, MDPrincipal InvestigatorGeisinger Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have injuries that prevent me from standing or walking normally.You have recently experienced a serious head injury.I have a condition or take medication that could affect my healing.I am being treated for a specific type of thigh bone fracture with surgery.I have or had kidney stones.I have or had Paget's disease, bone cancer, or other risky bone conditions.I have or had high calcium levels or a condition causing it, like hyperparathyroidism.I am 65 years old or older.I am having surgery to fix a broken bone with hardware.My surgery X-rays show my bones are not properly aligned.I have a broken bone that is exposed through my skin.
Research Study Groups:
This trial has the following groups:- Group 1: Control group
- Group 2: Abaloparatide group
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Abaloparatide been granted authorization from the Food and Drug Administration?
"There is ample evidence from Phase 4 trials that abaloparatide can be used safely, thus resulting in a score of 3."
Answered by AI
Are there still openings for participants in this venture?
"According to clinicaltrials.gov, this particular medical trial is no longer actively recruiting participants. Initially posted on July 1st 2022 and last updated on June 6th 2022, the study has since concluded recruitment; however 362 other trials are still seeking volunteers at present."
Answered by AI
How many participants are maximally enrolled in this clinical research?
"This clinical trial is no longer recruiting participants, as the last edit was made on June 6th 2022. For those interested in femoral fracture studies, there are 354 trials actively looking for patients and 7 different Abaloparatide interventions with open enrollment processes."
Answered by AI
Are there any additional explorations of Abaloparatide's efficacy that have been documented?
"Presently, 7 clinical trials are in progress for Abaloparatide. None of these have reached the Phase 3 phase yet. The majority of research is taking place near Madison, Wisconsin though there are 11 different testing centres across the nation."
Answered by AI
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