Osteopenic WomenNCT06799143
Copley II: Long-term Outcome Follow-up Study of Osteoporotic Women Who Underwent a Local Osteo-Enhancement Procedure (LOEP) in the Proximal Femur
An observational study of Osteopenic Women and Proximal Femur Fracture, run by AgNovos Healthcare, LLC.
Trial summary
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". Read more about this study
- Who is it for?
- Ages 56 years and older, women only
- Conditions the study is for
- Osteopenic Women, Proximal Femur Fracture
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 13 Jan 2016to 15 Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 56 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- participated in the original study and signed the consent form
- received treatment with AGN1 Femoral LOEP
- completed the study.
Who cannot join
- There is no exclusion criteria for this study.
About this study
Official title: Follow-up Evaluation of Osteoporotic Women Who Underwent a Local Osteo-Enhancement Procedure (LOEP) in the Proximal Femur
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.
Read the detailed description
This observational single arm study will be broken into two parts:
- A retrospective component which will evaluate the original FRAX score along with any events or medications received after the end of the original study.
- A prospective component which will evaluate longer term outcomes following the use of the AGN1 synthetic bone graft material in a local osteoenhancement procedure through evaluation of mobility and imaging.
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.
- Conditions
- Osteopenic Women, Proximal Femur Fracture
- Keywords
- LOEP, osteoporosis, femur fracture
- Medical subject headings
- Proximal Femoral Fractures, Osteoporosis, Femoral Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
Bone mineral density (BMD) assessed by DXA scans (T-score ) of the treated hip compared to nontreated hip (femoral neck).
Measured: 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).
Measured: through study completion, an average of 30 days
Bone Mineral Density
Percent change compared to baseline for the treated femoral neck measurement of BMD.
Measured: through study completion, an average of 30 days
Bone Mineral Density
Percent change compared to baseline for the untreated femoral neck measurement of BMD.
Measured: through study completion, an average of 30 days
Bone Mineral Density
Bilateral hip CT scan analysis of the trabecular bone density.
Measured: through study completion, an average of 30 days
Bone Mineral Density
Bilateral hip CT scan analysis of the trabecular bone volume.
Measured: through study completion, an average of 30 days
Bone Mineral Density
Bilateral hip CT scan analysis of the cortical bone density.
Measured: through study completion, an average of 30 days
Bone Mineral Density
Bilateral hip CT scan analysis of the cortical bone volume.
Measured: 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.
Measured: through study completion, an average of 30 days
Secondary outcomes (4)
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.
Measured: through study completion, an average of 30 days
Subject Interview
All osteoporosis medication use including vitamins and supplements from the twenty-four (24) month follow-up visit to current point-in-time.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start13 Jan 2016
- Primary completion25 Feb 2016
- Study completion15 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteopenic WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AgNovos Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799143
- Sponsor's protocol ID
- PRE-US-101.0
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Evaluation of Osteoporotic Women Who Underwent a Local Osteo-Enhancement Procedure (LOEP) in the Proximal Femur
- ClinicalTrials.gov ID
- NCT06799143
- Acronym / sponsor ID
- PRE-US-101.0
- Conditions
- Osteopenic Women, Proximal Femur Fracture
- Keywords
- LOEP, osteoporosis, femur fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AgNovos Healthcare, LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2016 (actual)
- Primary completion
- 25 Feb 2016 (actual)
- Study completion
- 15 Apr 2016 (actual)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This observational single arm study will be broken into two parts:
- A retrospective component which will evaluate the original FRAX score along with any events or medications received after the end of the original study.
- A prospective component which will evaluate longer term outcomes following the use of the AGN1 synthetic bone graft material in a local osteoenhancement procedure through evaluation of mobility and imaging.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 56 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- participated in the original study and signed the consent form
- received treatment with AGN1 Femoral LOEP
- completed the study.
Key exclusion criteria (1 listed)
- There is no exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone Mineral Density
Time frame: through study completion, an average of 30 days
Bone mineral density (BMD) assessed by DXA scans (T-score ) of the treated hip compared to nontreated hip (femoral neck).
Bone Mineral Density
Time frame: through study completion, an average of 30 days
Bone mineral density (BMD) assessed by DXA scans (absolute value measurement) of the treated hip compared to nontreated hip (femoral neck).
Bone Mineral Density
Time frame: through study completion, an average of 30 days
Percent change compared to baseline for the treated femoral neck measurement of BMD.
Bone Mineral Density
Time frame: through study completion, an average of 30 days
Percent change compared to baseline for the untreated femoral neck measurement of BMD.
Bone Mineral Density
Time frame: through study completion, an average of 30 days
Bilateral hip CT scan analysis of the trabecular bone density.
Bone Mineral Density
Time frame: through study completion, an average of 30 days
Bilateral hip CT scan analysis of the trabecular bone volume.
Bone Mineral Density
Time frame: through study completion, an average of 30 days
Bilateral hip CT scan analysis of the cortical bone density.
Bone Mineral Density
Time frame: through study completion, an average of 30 days
Bilateral hip CT scan analysis of the cortical bone volume.
Bone Mineral Density
Time frame: through study completion, an average of 30 days
Bilateral hip CT scan analysis of any qualitative observations compared to baseline CT scans.
4 secondary outcomes
Subject Interview
Time frame: through study completion, an average of 30 days
Subject Interview
Time frame: through study completion, an average of 30 days
Subject Interview
Time frame: through study completion, an average of 30 days
FRAX Index Risk Assessment
Time frame: through study completion, an average of 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteopenic Women and Proximal Femur Fracture, run by AgNovos Healthcare, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density (time frame: through study completion, an average of 30 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.