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New treatment option for Fragility Fracture
Official title RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures
ClinicalTrials.gov ID: NCT04796350
What this study is testing
- What it's testing
- A randomized controlled trial to evaluate AGN1 to prevent secondary hip fractures in osteoporotic women undergoing treatment of index hip fractures. Up to 2400 subjects will be randomized between a treatment group and a control group.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 91, women only
You may be able to join if
- Subject is a postmenopausal female at least 1-year post menses and at least 65 years of age and less than 92 years of age.
- Subject presents with a low-energy index fragility hip fracture in one hip and will undergo surgical repair of the fractured hip.
- Subject has at least one of the following additional risk factors for a secondary hip fracture (as determined by subject or legally authorized...
- Documented falls assessment indicating subject is at moderate or high risk of falls
- Falls history (2 or more falls in the previous 12 months)
You likely can't join if
- Criterion omitted
- Criterion omitted
- Subject is currently enrolled in another treatment clinical study affecting the target hip.
- Subject has a history of hip surgery or previous hip fracture on the target unfractured hip contralateral to the index hip fracture.
- Subject has new fractures in addition to the index hip fracture at admission that, in the opinion of the investigator, would further compromise...
- Subject has an infection at the LOEP intended treatment site or has non-intact skin or acute traumatic injuries with open wounds close to the area of...
See the full eligibility criteria
- Subject is a postmenopausal female at least 1-year post menses and at least 65 years of age and less than 92 years of age.
- Subject presents with a low-energy index fragility hip fracture in one hip and will undergo surgical repair of the fractured hip.
- Subject has at least one of the following additional risk factors for a secondary hip fracture (as determined by subject or legally authorized representative (LAR) interview or medical record review):
- Documented falls assessment indicating subject is at moderate or high risk of falls
- Falls history (2 or more falls in the previous 12 months)
- History of vertigo, dizziness, or postural hypotension
- Documented T-score \< -2.5 at the hip
- Taking more than 3 daily prescription medications
- Visual impairment as confirmed by one of the following:
- Subject reports difficulty seeing
- Lack of depth perception or vision loss in one eye
- Macular degeneration
- Cataracts
- Prior non-hip fragility fracture
- Cognitive frailty as assessed by SPMSQ (mild cognitive impairment determined by SPMSQ ≤ to 4) or delirium
- Parkinson's disease stage 3 or 4
- 10-year hip fracture probability \>15% using the FRAX® Fracture Risk Assessment Tool of the clinical site country
- Subject is expected to be ambulatory after the hip fracture repair procedure. "Ambulatory" is defined as a patient's ability to ambulate beyond simple transfers with or without assistive devices.
- Informed consent is provided by the subject or the subject's LAR. Use of an LAR to obtain patient consent requires that the patient must understand and be able to participate in post operative restrictions and...
- The subject's willingness, ability, and commitment to participate in screening, treatment, and all follow-up evaluations for the full duration of the study has been documented.
- Criterion omitted
- Criterion omitted
- Subject is currently enrolled in another treatment clinical study affecting the target hip.
- Subject has a history of hip surgery or previous hip fracture on the target unfractured hip contralateral to the index hip fracture.
- Subject has new fractures in addition to the index hip fracture at admission that, in the opinion of the investigator, would further compromise patient mobility, rehabilitation, or recovery.
- Subject has an infection at the LOEP intended treatment site or has non-intact skin or acute traumatic injuries with open wounds close to the area of intended LOEP treatment.
- Subject has a progressive increase in undiagnosed pain in the target hip contralateral to the index fractured hip over the previous 3 months that in the opinion of the Investigator may suggest underlying bone or joint...
- Subject has radiological evidence of gross bony or joint pathology of the hip, including signs predictive of atypical femoral fractures (e.g. cortical beaking), or has been diagnosed and/or treated for atypical femoral...
- Criterion omitted
- Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia).
- Criterion omitted
- Subject has active cancer
- Criterion omitted
- Criterion omitted
- Criterion omitted
- Criterion omitted
- Criterion omitted
- Subject has end stage renal insufficiency defined as an estimated glomerular filtration rate (eGFR) \< 15 mL/min.
- Criterion omitted
- Criterion omitted
- Subject has moderate or severe cognitive impairment as assessed by an SPMSQ of 5 or higher.
- Subject has known allergies to calcium-based bone void fillers.
- In the judgement of the Investigator, the subject is not a good study candidate (e.g., poor mental health, or active drug or alcohol abuse issues), and or subject would not be a good candidate to undergo an ELECTIVE...
- Subject fails pre-operative or intraoperative eligibility criteria as specified in section 7.4.2. of the clinical investigation plan.
The study team makes the final eligibility decision.
Where it's taking place
- Innsbruck, Austria
- Genk, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Sint-Niklaas, Belgium
- St. John's, Newfoundland and Labrador, Canada
- Halifax, Nova Scotia, Canada
- North York, Ontario, Canada
- Aarhus, Denmark
- Nice, Provence-Alpes-Côte d'Azur Region, France
- Amiens, France
- Grenoble, France
- Lyon, France
- Toulouse, France
- Berlin, Germany
- Düsseldorf, Germany
- Giessen, Germany
- Hanover, Germany
- Kiel, Germany
- München, Germany
+ 43 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65 years to 91 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Innsbruck, Austria; Genk, Belgium; Ghent, Belgium; Leuven, Belgium; Sint-Niklaas, Belgium; St. John's, Newfoundland and Labrador, Canada and 57 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.