Hip FracturesNCT03268356
STRONG - Study of AGN1 LOEP for the Treatment of the Contralateral Femur After Fragility Fracture
A study testing AGN1 Femoral Local Osteo-Enhancement Procedure Kit in people with Hip Fractures and Osteoporosis, Postmenopausal, run by AgNovos Healthcare, LLC at 1 site in Hong Kong.
Trial summary
To evaluate the procedure and safety profile of the AGN1 Femoral LOEP Kit. This pilot study will be used to evaluate AGN1 Femoral LOEP treatment in a contralateral proximal femur during hip fracture repair. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Hip Fractures, Osteoporosis, Postmenopausal
- What is being tested?
- AGN1 Femoral Local Osteo-Enhancement Procedure Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Aug 2017to 31 Dec 2020
- Phase
- Interventional
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Subject is a postmenopausal female
- Subject has a low-energy fragility hip fracture in one hip and will undergo surgical repair of the fractured hip.
- Subject is ≥ 65 years of age.
- Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full duration of the study.
- Subject is capable of giving written informed consent to participate in the study.
Who cannot join
- Subject has a prior diagnosis of secondary osteoporosis.
- Subject has history of any hip surgery or previous hip fracture in the non-fractured hip.
- Subject has progressive increase in undiagnosed hip pain over the previous six (6) months that in the opinion of the Investigator may suggest other underlying bone or joint pathology (e.g. osteoarthritis, fracture, etc.).
- Subject has serum calcium levels outside the normal lab range as per local guidelines and reference ranges.
- Subject has moderate to severe renal insufficiency as per local guidelines and reference ranges.
- Subject has insulin-dependent diabetes mellitus (IDDM).
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- Subject has Body Mass Index (BMI) > 30.
- Subject exhibits excessive smokeless tobacco use or excessive smoking as determined by the principal investigator*.
- Subject exhibits excessive alcohol consumption as determined by the principal investigator*.
- Subject has radiological evidence of gross bony or joint pathology of the non-fractured hip.
- Subject treated with corticosteroids or systemic glucocorticoids for ten (10) days in the previous six (6) months.
- Subject has history of oral or parenteral use of immune-suppressive drugs in the previous twelve months.
- Subject has history of metabolic bone disease other than osteoporosis (eg. Paget's disease).
- Subject has a history of auto-immune arthritic diseases including rheumatoid, psoriatic, or those associated with systemic lupus erythematosus, spondyloarthropathy, Reiter's Syndrome or Crohn's Disease.
- Subject has a history of radiation therapy to the hip or pelvic region.
- Subject has history of chemotherapy treatment for any condition within the previous five years.
- Subject has history of any diagnosis and treatment of malignancies (excluding basal cell carcinoma) within the previous five years.
- Subject has known allergies to implanted device.
- Subject has severe comorbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate.
- Subject is currently enrolled in another clinical study.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Queen Mary Hospital - Department of Orthopaedics and Traumatology
Hong Kong
About this study
Official title: Clinical Investigation of a Local Osteo-Enhancement Procedure's (LOEP) Ability to Strengthen the Contralateral Femur of Women After a Fragility Fracture of the Hip in Hong Kong
To evaluate the procedure and safety profile of the AGN1 Femoral LOEP Kit. This pilot study will be used to evaluate AGN1 Femoral LOEP treatment in a contralateral proximal femur during hip fracture repair.
Read the detailed description
The research will be conducted as a prospective single-center study within Hong Kong. The maximum number of subjects to be treated is twenty (20). This will be a non-randomized and non-blinded study.
Subjects having had a fragility hip fracture on one side will be treated with LOEP in the contralateral non-fractured proximal femur in the same operative session as the surgical repair of the fractured hip. A fragility fracture is defined as a fracture resulting from a fall from standing height.
All subjects will undergo hip fracture repair as recommended by the treating orthopedic surgeon. Repair may include nailing, plates, screws and hip prosthesis.
Subjects may continue to receive, or when appropriate, can be commenced on a treatment regime for osteoporosis. This decision will be made by the treating physician who will determine the best course of action for each patient. The outcome of this decision will have not affect the patient's eligibility for this trial.
Follow-up visits will be conducted at three (3) months, six (6) months, twelve (12) months, and twenty-four (24) months after the procedure.
- Conditions
- Hip Fractures, Osteoporosis, Postmenopausal
- Being tested
- AGN1 Femoral Local Osteo-Enhancement Procedure Kit
- Medical subject headings
- Hip Fractures, Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN1 Femoral Local Osteo-Enhancement Procedure KitDevice
Also called AGN1 Femoral LOEP™
A procedure that is intended to replace lost bone and increase the strength of the proximal femur in individuals with osteoporosis of the femoral neck.
| Study group | Role | What they receive |
|---|---|---|
| AGN1 Treatment | Other | Subjects who have suffered a fragility hip fracture in one hip, sign the consent form and meet the inclusion and none of the exclusion of the study will receive the AGN1 Femoral Local Osteo-Enhancement Procedure (LOEP™) in the non-fractured hip. Receives: Device: AGN1 Femoral Local Osteo-Enhancement Procedure Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment or Device Emergent Serious Adverse Events
Incidence of all serious adverse events (SAEs) occurring from the day of procedure through the twenty-four (24) month follow-up period determined to be definitely related to Femoral LOEP and/or the AGN1 device.
Measured: 24 Months
Secondary outcomes (4)
Incidence of Non-Treatment Emergent Fragility Fractures
Incidence of fragility fractures unrelated to the device or procedure occurring during the follow-up period.
Measured: 24 Months
Incidence of Treatment or Device Emergent Adverse Events
Incidence of all adverse events occurring from the day of procedure through the twenty-four (24) month follow-up determined to be definitely related to Femoral LOEP and/or the AGN1 device.
Measured: 24 Months
Change in Bone Mineral Density between Baseline and 12 Months
Evaluation of bone mineral density (BMD) post-procedure at twelve (12) months.
Measured: 12 Months
Change in Bone Mineral Density between Baseline and 24 Months
Evaluation of bone mineral density (BMD) post-procedure at twenty-four (24) months.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start15 Aug 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- AgNovos Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Fang, MD, Principal investigator, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268356
- Sponsor's protocol ID
- PST-HK-100.1
- Status last verified
- Nov 2022
- First submitted
- 29 Aug 2017
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of a Local Osteo-Enhancement Procedure's (LOEP) Ability to Strengthen the Contralateral Femur of Women After a Fragility Fracture of the Hip in Hong Kong
- ClinicalTrials.gov ID
- NCT03268356
- Acronym / sponsor ID
- PST-HK-100.1
- Conditions
- Hip Fractures, Osteoporosis, Postmenopausal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- AgNovos Healthcare, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 31 Aug 2017 (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 the procedure and safety profile of the AGN1 Femoral LOEP Kit. This pilot study will be used to evaluate AGN1 Femoral LOEP treatment in a contralateral proximal femur during hip fracture repair.
Detailed description
The research will be conducted as a prospective single-center study within Hong Kong. The maximum number of subjects to be treated is twenty (20). This will be a non-randomized and non-blinded study.
Subjects having had a fragility hip fracture on one side will be treated with LOEP in the contralateral non-fractured proximal femur in the same operative session as the surgical repair of the fractured hip. A fragility fracture is defined as a fracture resulting from a fall from standing height.
All subjects will undergo hip fracture repair as recommended by the treating orthopedic surgeon. Repair may include nailing, plates, screws and hip prosthesis.
Subjects may continue to receive, or when appropriate, can be commenced on a treatment regime for osteoporosis. This decision will be made by the treating physician who will determine the best course of action for each patient. The outcome of this decision will have not affect the patient's eligibility for this trial.
Follow-up visits will be conducted at three (3) months, six (6) months, twelve (12) months, and twenty-four (24) months after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AGN1 Treatment | Other | Device: AGN1 Femoral Local Osteo-Enhancement Procedure KitSubjects who have suffered a fragility hip fracture in one hip, sign the consent form and meet the inclusion and none of the exclusion of the study will receive the AGN1 Femoral Local Osteo-Enhancement Procedure (LOEP™) in the non-fractured hip. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Subject is a postmenopausal female
- Subject has a low-energy fragility hip fracture in one hip and will undergo surgical repair of the fractured hip.
- Subject is ≥ 65 years of age.
- Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full duration of the study.
- Subject is capable of giving written informed consent to participate in the study.
Key exclusion criteria (20 listed)
- Subject has a prior diagnosis of secondary osteoporosis.
- Subject has history of any hip surgery or previous hip fracture in the non-fractured hip.
- Subject has progressive increase in undiagnosed hip pain over the previous six (6) months that in the opinion of the Investigator may suggest other underlying bone or joint pathology (e.g. osteoarthritis, fracture, etc.).
- Subject has serum calcium levels outside the normal lab range as per local guidelines and reference ranges.
- Subject has moderate to severe renal insufficiency as per local guidelines and reference ranges.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGN1 Femoral Local Osteo-Enhancement Procedure KitAlso: AGN1 Femoral LOEP™A procedure that is intended to replace lost bone and increase the strength of the proximal femur in individuals with osteoporosis of the femoral neck. | Device | AGN1 Treatment |
Primary outcome
Incidence of Treatment or Device Emergent Serious Adverse Events
Time frame: 24 Months
Incidence of all serious adverse events (SAEs) occurring from the day of procedure through the twenty-four (24) month follow-up period determined to be definitely related to Femoral LOEP and/or the AGN1 device.
4 secondary outcomes
Incidence of Non-Treatment Emergent Fragility Fractures
Time frame: 24 Months
Incidence of Treatment or Device Emergent Adverse Events
Time frame: 24 Months
Change in Bone Mineral Density between Baseline and 12 Months
Time frame: 12 Months
Change in Bone Mineral Density between Baseline and 24 Months
Time frame: 24 Months
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 30 Nov 2022.
- Company websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Christian Fang, MD principal investigator
Queen Mary Hospital, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AGN1 Femoral Local Osteo-Enhancement Procedure Kit in people with Hip Fractures and Osteoporosis, Postmenopausal, run by AgNovos Healthcare, LLC at 1 site in Hong Kong.
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 5 inclusion and 20 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 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Incidence of Treatment or Device Emergent Serious Adverse Events (time frame: 24 Months). 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 30 Nov 2022.