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To evaluate longer-term (5-7 years) outcomes of the twelve (12) subjects treated with AGN1 Femoral LOEP in the clinical study "A Prospective Pilot Evaluation of Percutaneous Osteo-supplementation in the Proximal Femur of Osteoporotic Patients". Performance will be evaluated via medical history evaluation, X-ray, DXA, CT and mobility testing.
The study will look at the extent to which the benefits demonstrated in the initial, baseline study were sustained over time. In this manner, it may be possible to determine the rate of change in BMD following the treatment; thereby allowing prediction of the total benefit period. In addition, this longer period of observation allows for further evaluation of the safety profile of the material in osteoporosis patients.
This observational single arm study will be broken into two parts:
In the original study, subjects completed a twenty-four (24) month follow-up visit after receiving a unilateral hip injection with the device. The contralateral hip acted as the control. The purpose of the study was to determine the safety of the injection as well as the initial improvement in femoral bone density in a twenty-four (24) month period.
In this follow-up study the subjects, after signing the informed consent form, will complete a short medical history (focused on their osteoporosis management) and a mobility test.
Subjects will also undergo a DXA, X-ray and CT scans of both hips.
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| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density | Bone mineral density (BMD) assessed by DXA scans (T-score ) of the treated hip compared to nontreated hip (femoral neck). | through study completion, an average of 30 days |
| Bone Mineral Density | Bone mineral density (BMD) assessed by DXA scans (absolute value measurement) of the treated hip compared to nontreated hip (femoral neck). | through study completion, an average of 30 days |
| Bone Mineral Density | Percent change compared to baseline for the treated femoral neck measurement of BMD. | through study completion, an average of 30 days |
| Bone Mineral Density | Percent change compared to baseline for the untreated femoral neck measurement of BMD. | through study completion, an average of 30 days |
| Bone Mineral Density | Bilateral hip CT scan analysis of the trabecular bone density. | through study completion, an average of 30 days |
| Bone Mineral Density | Bilateral hip CT scan analysis of the trabecular bone volume. | through study completion, an average of 30 days |
| Bone Mineral Density | Bilateral hip CT scan analysis of the cortical bone density. | through study completion, an average of 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Interview | All osteoporosis related events (as defined by the Investigator) from the twenty-four (24) month follow-up visit to current point-in-time including fragility fractures, changes in mobility and medication reactions. | through study completion, an average of 30 days |
| Subject Interview |
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Inclusion Criteria:
Exclusion Criteria:
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Females aged 56 or older and menses have ceased for at least one year. Subjects that were participants in the original study that signed a consent form, received treatment with AGN1 Femoral LOEP and completed the original study.
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| ID | Term |
|---|---|
| D000092526 | Proximal Femoral Fractures |
| D010024 | Osteoporosis |
| D005264 | Femoral Fractures |
| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| D006620 | Hip Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| Bone Mineral Density | Bilateral hip CT scan analysis of the cortical bone volume. | through study completion, an average of 30 days |
| Bone Mineral Density | Bilateral hip CT scan analysis of any qualitative observations compared to baseline CT scans. | through study completion, an average of 30 days |
All osteoporosis medication use including vitamins and supplements from the twenty-four (24) month follow-up visit to current point-in-time. |
| through study completion, an average of 30 days |
| Subject Interview | Any physical activity/exercise program from the twenty-four (24) month follow-up visit to current point-in-time. | through study completion, an average of 30 days |
| FRAX Index Risk Assessment | Comparative calculation of a FRAX index for hip fracture risk based on BMD data from the treatment and contralateral hip using pre-procedure data compared to current point-in-time. | through study completion, an average of 30 days |
| D025981 |
| Hip Injuries |
| D007869 | Leg Injuries |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |