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AGN1 LOEP for Preventing Secondary Hip Fractures (RESTORE Trial)
N/A
Recruiting
Research Sponsored by AgNovos Healthcare, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Postmenopausal female at least 1-year post menses and at least 65 years of age
Expected to be ambulatory after the hip fracture repair procedure
Must not have
Diagnosed and ongoing calcium metabolism disorder
Dependent on the use of a wheelchair or bedridden prior to the index hip fracture
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months and 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test a new drug, AGN1, to see if it can prevent second hip fractures in women with osteoporosis who are already being treated for their first hip fracture. Around
Who is the study for?
This trial is for postmenopausal women aged 65 or older with osteoporosis who have had a low-energy hip fracture and are at moderate to high risk of falls. They must be undergoing surgery for the hip fracture, have a history of multiple falls, issues with dizziness or blood pressure changes when standing, poor bone density scores, take several prescription meds daily, and may have vision problems including macular degeneration.
What is being tested?
The RESTORE study is testing AGN1 LOEP treatment's effectiveness in preventing secondary hip fractures in women after their initial surgical repair. Participants will either receive this new treatment or be part of a control group not receiving it. The study involves up to 2400 subjects followed over at least five years.
What are the potential side effects?
While specific side effects are not listed here, treatments like AGN1 LOEP could potentially cause discomfort at the site of application, infection risks from additional procedures involved in administering the treatment, allergic reactions or interactions with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman over 65 and have not had a period for at least a year.
Select...
I expect to walk after my hip surgery.
Select...
I have a hip fracture from a minor injury and will have surgery to fix it.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a diagnosed disorder affecting my calcium levels.
Select...
I was using a wheelchair or was bedridden before my hip fracture.
Select...
I have multiple new fractures besides my hip fracture that affect my mobility or recovery.
Select...
My health is severely limited by my illness.
Select...
I have a bone condition that is not osteoporosis.
Select...
I have had Pott's disease in the past.
Select...
I have severe heart issues or a pacemaker.
Select...
I am taking medication to suppress my immune system.
Select...
My kidney function is severely low.
Select...
I have significant difficulty with moving around on my own.
Select...
I have had hip surgery or a fracture on the hip opposite to my current hip fracture.
Select...
I do not have infections, open wounds, or non-intact skin near my treatment area.
Select...
I have increasing pain in my hip opposite to the one that was fractured.
Select...
I have had hip problems, including unusual fractures.
Select...
I have not had a heart attack or stroke in the last 3 months.
Select...
My diabetes is not under control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months and 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cumulative Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Cumulative incidence of secondary fragility hip fractures
Secondary study objectives
Areal bone mineral density (aBMD)
Trabecular Bone Score (TBS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treated groupExperimental Treatment1 Intervention
Subject receives standard of care to repair the index hip fracture and AGN1 LOEP treatment on the target unfractured contralateral hip
Group II: Control groupActive Control1 Intervention
Subject receives standard of care to repair the index hip fracture and no AGN1 LOEP treatment on the target unfractured contralateral hip
Find a Location
Who is running the clinical trial?
BioClinica, Inc.Industry Sponsor
7 Previous Clinical Trials
618 Total Patients Enrolled
Emergent Clinical Consulting, LLCIndustry Sponsor
4 Previous Clinical Trials
369 Total Patients Enrolled
CMIC Co, Ltd. JapanIndustry Sponsor
10 Previous Clinical Trials
1,403 Total Patients Enrolled
Baim Institute for Clinical ResearchOTHER
28 Previous Clinical Trials
53,250 Total Patients Enrolled
AgNovos Healthcare, LLCLead Sponsor
7 Previous Clinical Trials
835 Total Patients Enrolled
5 Trials studying Osteoporosis
327 Patients Enrolled for Osteoporosis
AvaniaIndustry Sponsor
52 Previous Clinical Trials
7,659 Total Patients Enrolled
1 Trials studying Osteoporosis
134 Patients Enrolled for Osteoporosis