CompletedNot Applicable

STRONG - Study of AGN1 LOEP for the Treatment of the Contralateral Femur After Fragility Fracture

Hong Kong13 participantsStarted 2017-08-15

Plain-language summary

To evaluate the procedure and safety profile of the AGN1 Femoral LOEP Kit. This pilot study will be used to evaluate AGN1 Femoral LOEP treatment in a contralateral proximal femur during hip fracture repair.

Who can participate

Age range

65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject is a postmenopausal female
. Subject has a low-energy fragility hip fracture in one hip and will undergo surgical repair of the fractured hip.
. Subject is ≥ 65 years of age.
. Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full duration of the study.
. Subject is capable of giving written informed consent to participate in the study.

Exclusion criteria

. Subject has a prior diagnosis of secondary osteoporosis.
. Subject has history of any hip surgery or previous hip fracture in the non-fractured hip.
. Subject has progressive increase in undiagnosed hip pain over the previous six (6) months that in the opinion of the Investigator may suggest other underlying bone or joint pathology (e.g. osteoarthritis, fracture, etc.).
. Subject has serum calcium levels outside the normal lab range as per local guidelines and reference ranges.
. Subject has moderate to severe renal insufficiency as per local guidelines and reference ranges.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Treatment or Device Emergent Serious Adverse Events

Timeframe: 24 Months

Trial details

NCT IDNCT03268356

SponsorAgNovos Healthcare, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12-31

View on ClinicalTrials.gov More Hip Fractures trials