RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis
ConditionOsteoporosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorAgNovos Healthcare, LLC
About this trial
The research will be conducted as a prospective, post-market, multi-center study within Europe. The maximum number of subjects to be treated is 150 across up to 20 sites. This will be a non-randomized and open-label study. The study will collect procedural, short- and long-term data on the safety and clinical performance of AGN1 LOEP in the post-market setting in European countries where AGN1 LOEP is commercially available. AGN1 is intended to form new bone in voids in the proximal femur of women with osteoporosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is a postmenopausal female (at least 1-year post menses).
Subject has bone loss in the hip attributable to osteoporosis as defined by a femoral neck DXA T-score of -2.5 or less.
Subject has at least one hip without previous surgery or fracture.
Subject is medically stable from any previous treatment or medical procedure in the opinion of the investigator and with an ASA score of I or II.
Disqualifiers
Subject is less than 3 months removed from having a hip fracture repair or prosthesis or elective Total Hip Arthroplasty (THA).
Subject has progressive increase in hip pain over the previous six (6) months that in the opinion of the Investigator suggests moderate to severe intra-articular arthritis, labral tear, extraarticular soft tissue pathology, referred pain, tumor, stress fracture or infection.
Subject is dependent on the use of a wheelchair or is bedridden.
Subject has albumin corrected serum calcium levels outside the normal lab range or has a pre-existing calcium metabolism disorder (e.g., hypercalcemia).
Trial design
Design model
Single group
Treatments tested in this trial
AGN1 LOEP
DeviceSubjects with osteoporosis are treated with AGN1 local osteo-enhancement procedure in the proximal femur
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: AGN1 LOEPOther 1 intervention
Trial outcomes
Primary outcomes
1
Femoral Neck Bone Mineral Density
6% increase in mean femoral neck BMD from preprocedure baseline to 12 months post-procedure of treated hips
Time frame
12 months2
Primary Safety Evaluation
The incidence of all adverse events and serious adverse events occurring post-AGN1 LOEP through the 12 months follow-up period determined to be at least possibly related to the procedure and/or device.
Time frame
12 monthsSecondary outcomes
1
Total Hip Bone Mineral Density
6% increase in mean total hip BMD from preprocedure baseline to 12 months post-procedure of treated hips.
Time frame
12 months2
Femoral Neck Bone Mineral Density
6% increase in mean femoral neck BMD from preprocedure baseline to 24 months post-procedure of treated hips.
Time frame
24 months3
Total Hip Bone Mineral Density
6% increase in mean total hip BMD from preprocedure baseline to 24 months post-procedure of treated hips.
Time frame
24 monthsOther outcomes
1
Bone Formation
Radiologic appearance of bone formation as assessed by X-ray at 12 and 24 months post-procedure of treated hips.
Time frame
12 and 24 months2
Patient Satisfaction
Patient satisfaction with outcome of surgery in the treated hip(s) and overall at 42 days and 12 months assessed with Visual Analogue Scale.
Time frame
42 days and 12 months3
Pain hip
Pain (left hip, right hip) at baseline, 42 days, 12 months, and 24 months assessed with Visual Analogue Scale.
Time frame
baseline, 42 days, 12 months, and 24 months.4
Pain body overall
Pain body overall at baseline, 42 days, 12 months, and 24 months assessed with Visual Analogue Scale.
Time frame
baseline, 42 days, 12 months, and 24 months.Sponsors and contacts
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Source ClinicalTrials.gov