AGN1 LOEP for Preventing Secondary Hip Fractures
(RESTORE Trial)
Recruiting in Palo Alto (17 mi)
+49 other locations
Age: 65+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: AgNovos Healthcare, LLC
Must not be taking: Immuno-suppressive drugs
Disqualifiers: Wheelchair dependent, Metabolic bone disease, Invasive malignancy, Severe cardiovascular disease, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
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. Subjects will be followed for a minimum of 5 years after undergoing hip fracture repair surgery.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on oral or parenteral immuno-suppressive drugs, you may not be eligible to participate.
What data supports the effectiveness of the AGN1 LOEP treatment for preventing secondary hip fractures?
Research shows that the AGN1 LOEP treatment, which involves injecting a special calcium-based material into the bone, can immediately make bones stronger. In a study using human bones, this treatment increased the strength of the bones by about 20%, suggesting it could help prevent future fractures.12345
Is the AGN1 LOEP treatment generally safe for humans?
How is the AGN1 LOEP treatment different from other treatments for preventing secondary hip fractures?
The AGN1 LOEP treatment is unique because it involves a specific kit designed for the prevention of secondary hip fractures, which may include novel components or methods not typically used in standard treatments for this condition. Unlike other treatments that focus on managing avascular necrosis or osteonecrosis, this treatment is specifically tailored for hip fracture prevention.1011121314
Research Team
Eligibility Criteria
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.Inclusion Criteria
Informed consent provided by the subject or the subject's legally authorized representative
Has at least one additional risk factor for a secondary hip fracture
Willingness, ability, and commitment to participate in screening, treatment, and all follow-up evaluations for the full duration of the study documented
See 3 more
Exclusion Criteria
I have a diagnosed disorder affecting my calcium levels.
Currently enrolled in another clinical study
I have multiple new fractures besides my hip fracture that affect my mobility or recovery.
See 21 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo hip fracture repair surgery and receive AGN1 LOEP treatment or standard care
Immediate post-surgery
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
5 years
Visits at 6 weeks, 6 months, and every 6 months thereafter
Treatment Details
Interventions
- AGN1 LOEP treatment (Device)
Trial OverviewThe 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.
Participant Groups
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
AGN1 LOEP treatment is already approved in European Union for the following indications:
🇪🇺 Approved in European Union as OSSURE LOEP Kit for:
- Prevention of secondary hip fractures in osteoporotic women undergoing treatment of index hip fractures
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Health Sciences Centre - Eastern HealthSaint John's, Canada
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Who Is Running the Clinical Trial?
AgNovos Healthcare, LLC
Lead Sponsor
Trials
9
Patients Recruited
3,200+
BioClinica, Inc.
Industry Sponsor
Trials
8
Patients Recruited
3,000+
Emergent Clinical Consulting, LLC
Industry Sponsor
Trials
6
Patients Recruited
2,900+
CMIC Co, Ltd. Japan
Industry Sponsor
Trials
11
Patients Recruited
3,800+
Baim Institute for Clinical Research
Collaborator
Trials
29
Patients Recruited
55,700+
Avania
Industry Sponsor
Trials
59
Patients Recruited
10,000+
References
In vitro injection of osteoporotic cadaveric femurs with a triphasic calcium-based implant confers immediate biomechanical integrity. [2023]Current pharmaceutical therapies can reduce hip fractures by up to 50%, but compliance to treatment is low and therapies take up to 18 months to reduce risk. Thus, alternative or complementary approaches to reduce the risk of hip fracture are needed. The AGN1 local osteo-enhancement procedure (LOEP) is one such alternative approach, as it is designed to locally replace bone lost due to osteoporosis and provide immediate biomechanical benefit. This in vitro study evaluated the initial biomechanical impact of this treatment on human cadaveric femurs. We obtained 45 pairs of cadaveric femurs from women aged 77.8 ± 8.8 years. One femur of each pair was treated, while the contralateral femur served as an untreated control. Treatment included debridement, irrigation/suction, and injection of a triphasic calcium-based implant (AGN1). Mechanical testing of the femora was performed in a sideways fall configuration 24 h after treatment. Of the 45 pairs, 4 had normal, 16 osteopenic, and 25 osteoporotic BMD T-scores. Altogether, treatment increased failure load on average by 20.5% (p
Adherence to the recommended prevention strategies before and after a hip fragility fracture: what makes us go blind? [2019]Our main objective was to evaluate the percentage of patients under anti-osteoporotic treatment (OT) at the time of hip fracture (HF) and one and four years after the HF event. We compared these results with the percentage of patients who should be under treatment at all three stages, according to the recently published Portuguese cost-effectiveness recommendations (PCER) for OT. Data regarding occurrence of new fragility fractures and mortality were also determined, one and four years after the HF event. Our secondary objective was to evaluate characteristics of patients associated with OT at the time of hip fracture..
Overcoming barriers to osteoporosis care in vulnerable elderly patients with hip fractures. [2022]Indications for and benefits of providing osteoporosis (OP) care for hip fracture patients have become widely understood. The hip fracture patient is frequently over age 80 years, minimally ambulatory, has multiple medical comorbidities, and has cognitive impairment. Patient barriers to initiation of effective OP treatment include: age, dementia, medical comorbidities, polypharmacy, lack of adherence with treatment, alcohol abuse, postoperative delirium, language barriers, inadequate social support, and socioeconomic status. In a large teaching hospital, 244 patients presented with hip fracture over 2 years: 72% were female and 64% were over age 80. Forty percent had been diagnosed with dementia; another 29% had other severe medical comorbidities.Opportunities for OP diagnosis and treatment are numerous. In acute care hospitals, coordinator facilitated programs are effective for identification, education, assessment, referral, and treatment of underlying OP in fracture patients. System modifications may include an automated care path or automatic specialist referral for hip fracture patients. In the rehabilitation hospital, the patients are in a more stable condition, there is a focus on the recent fracture, and there are opportunities to initiate OP treatment and to promote adherence. In long-term care, dietary intake including calcium and vitamin D supplementation and persistence with pharmacotherapy can be monitored. Patient education and referral to the family physician for osteoporosis investigation and treatment have improved patient knowledge and diagnosis, but the reported impact on treatment has been limited.Effective OP care for the vulnerable hip fracture patient should be initiated early but may be complex and require coordination. In addition to calcium and vitamin D supplementation, most patients in this category have an indication for aminobisphosphonate therapy. Liaison between the orthopaedic team and the discharge destination caregivers, an established discharge diagnosis of osteoporosis, and ensuring patients are discharged on supplements and medication will promote patient, caregiver, and primary care physician awareness of the patient's OP care needs. Education programs may provide benefits at later stages, to improve adherence with treatment.
The role of the orthopaedic surgeon in minimizing mortality and morbidity associated with fragility fractures. [2022]Osteoporosis is an underrecognized and undertreated condition associated with fracture. More than 2 million fragility fractures occur each year, almost 300,000 of them hip fractures associated with a threefold risk for future fractures, as well as a 15% to 33% mortality rate within the first year of fracture. Orthopaedic surgeons can facilitate osteoporosis treatment by coordinating care for patients with fragility fractures by managing the current fracture, evaluating risk factors for osteoporosis, and, for hospitalized patients, developing a follow-up plan that notes whether the patient should be further evaluated or treated for osteoporosis. For the patient seen in the office, evaluation for osteoporosis should be performed and, if indicated, treatment should be undertaken. When osteoporosis treatment is warranted, diphosphonates are the standard of care, and administration of zoledronic acid once yearly has been proven to reduce the risk of subsequent fractures after low-energy hip fracture. By following these steps, orthopaedic surgeons can help ensure that patients with fragility fractures receive appropriate osteoporotic treatment, thereby reducing the risk of subsequent fractures.
Evaluation of a multidisciplinary rehabilitation programme for elderly patients with hip fracture: A prospective cohort study. [2018]To investigate the effectiveness and cost of an 18-month multi-disciplinary Comprehensive Fragility Fracture Management Program (CFFMP) for fragility hip fracture patients.
Treatment of bone loss in proximal femurs of postmenopausal osteoporotic women with AGN1 local osteo-enhancement procedure (LOEP) increases hip bone mineral density and hip strength: a long-term prospective cohort study. [2021]This first-in-human study of AGN1 LOEP demonstrated that this minimally-invasive treatment durably increased aBMD in femurs of osteoporotic postmenopausal women. AGN1 resorption was coupled with new bone formation by 12 weeks and that new bone was maintained for at least 5-7 years resulting in substantially increased FEA-estimated femoral strength.
AGN1 implant material to treat bone loss: Resorbable implant forms normal bone with and without alendronate in a canine critical size humeral defect model. [2022]Fractures secondary to osteoporosis, particularly those of the hip and spine, are a major public health concern with high social and economic costs. The Local Osteo-Enhancement Procedure (LOEP) is an approach intended to strengthen skeletal areas that are at the highest risk for fracture due to osteoporosis. LOEP involves the implantation of AGN1, a triphasic, calcium-based, osteoconductive material which is then resorbed and replaced by bone. Since alendronate is the most prescribed osteoporotic treatment, the purpose of this canine study is to determine if the newly formed bone has the same properties as normal bone and whether alendronate treatment impacts AGN1 resorption and replacement with bone.
Fracture rates in patients discontinuing alendronate treatment in real life: a population-based cohort study. [2021]In this nationwide register-based cohort study, we found no difference in the risk of fractures in patients discontinuing versus continuing alendronate (ALN) treatment after 5 years.
Cost-effectiveness of sequential treatment with abaloparatide followed by alendronate vs. alendronate monotherapy in women at increased risk of fracture: A US payer perspective. [2021]Emerging evidence supports sequential therapy with anabolic followed by antiresorptive in patients at high-risk of fragility fractures. This study assessed the cost-effectiveness of sequential treatment with abaloparatide (ABL) followed by alendronate (ALN) [(ABL/ALN)] compared to ALN monotherapy and to sequential treatment starting with antiresorptive therapy (ALN/ABL/ALN).
[Effectiveness of multiple small-diameter drilling decompression combined with hip arthroscopy for early osteonecrosis of the femoral head]. [2021]To evaluate the effectiveness of multiple small-diameter drilling decompression combined with hip arthroscopy for early oeteonecrosis of the femoral head (ONFH).
Modifications to advanced Core decompression for treatment of Avascular necrosis of the femoral head. [2018]Label="BACKGROUND" NlmCategory="BACKGROUND">"Advanced Core Decompression" (ACD) is a new technique for treatment of osteonecrosis of the femoral head (ONFH) that includes removal of the necrotic tissue using a percutaneous expandable reamer followed by refilling of the drill hole and the defect with an injectable, hard-setting, composite calcium sulphate (CaSO4)-calcium phosphate (CaPO4) bone graft substitute. As autologous bone has been shown to be superior to all other types of bone grafts, the aim of the study is to present and evaluate a modified technique of ACD with impaction of autologous bone derived from the femoral neck into the necrotic defect.
Efficacy of alendronate, a bisphosphonate, in the treatment of AVN of the hip. A prospective open-label study. [2016]To study the efficacy of alendronate, in the treatment of avascular necrosis (AVN) of the hip.
Management of avascular necrosis of femoral head at pre-collapse stage. [2022]In osteonecrosis the success of interventions that forestall or prevent femoral head collapse and maintain hip function would represent a substantial achievement in the treatment of this disease. A review of recent literature regarding bisphosphonate, anticoagulant, and vasodilators and biophysical modalities have demonstrated efficacy in reducing pain and delaying disease progression in early stage osteonecrosis. Though it has been considered still insufficient, to support their routine use in the treatment or prevention of osteonecrosis of the hip. Core decompression with modification of technique is still one of the safest and most commonly employed procedures with evidence based success in the pre-collapse stage of AVN of femoral head. The additional use of bone morphogenic protein, and bone marrow stem cells may provide the opportunity to enhance the results of core decompression. At present, the use of large vascularised cortical grafts, the other surgical procedure with high success rate is still not common due to technical difficulty in surgery. Likewise osteotomies are also not getting common as arthroplasty is getting more acceptable, so is awaited without any intermediate big surgical interventions.
Bisphosphonate combination therapy for non-femoral avascular necrosis. [2020]Avascular necrosis at sites other than femoral head (AVNOFH)/Non-Femoral AVN is a rare entity. No standard of treatment still exists for treating early stages of AVNOFH with most of the cases eventually progressing to a late arthritic stage needing surgical intervention. Bisphosphonates have been shown to prevent disease progression, bone collapse, and the requirement for surgery in avascular necrosis of femoral head. The present study is conducted to evaluate the response of bisphosphonates in the non-surgical management of the early stages of AVNOFH.