Femoral FracturesPhase 4NCT04626141
Supracondylar Distal Femur Fractures and Abaloparatide
A Phase 4 study testing Abaloparatide in people with Femoral Fractures, run by Daniel Horwitz at 1 site in United States.
Trial summary
Supracondylar femur fractures in the geriatric population present a unique challenge to the orthopaedic surgeon both in terms of fixation, healing, and final extremity axial alignment. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Femoral Fractures
- What is being tested?
- Abaloparatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2024to Jun 2025
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subject is ≥ 65 years old
- Subject is willing and able to read, comprehend, and sign the study informed consent form in English prior to study specific procedure
- Subject is being treated for a closed supracondylar distal femur fracture with either a retrograde nail or locked plate
- Subject undergoes open reduction/fixation
Who cannot join
- Subject has open fracture
- Bilateral injury or other lower extremity injury that would affect weight bearing status
- Subject's postoperative radiographs (on day of surgery) indicate failure to achieve axial alignment (more than 10 degrees axial alignment and more than 25% anterior/posterior displacement in lateral view)
- Subject has additional severe traumatic conditions such as closed head injury
- Subject has medical condition or is on medication that may significantly affect healing (i.e. immunosuppressive diseases and drugs)
- Subject has active or history of Paget's disease of the bone, bone cancer, or other bone diseases or conditions placing them at increased risk of osteosarcoma
Show all 9Show fewer
- Subject has active or history of hypercalcemia or underlying hypercalcemic disorder, such as primary hyperparathyroidism
- Subject has active or a history of urolithiasis
- Subject will have trouble injecting the pen and does not have someone to help them on a daily basis
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Medical Center
Danville, Pennsylvania, 17822
About this study
Official title: Time to Healing, Loss of Fixation, and Loss of Alignment in Supracondylar Distal Femur Fractures Among a Geriatric Population Treated With Abaloparatide: A Double-Blind Placebo Controlled Study
Supracondylar femur fractures in the geriatric population present a unique challenge to the orthopaedic surgeon both in terms of fixation, healing, and final extremity axial alignment. Pulsed dosing of parathyroid hormone derivatives (Forteo) has been shown to increase bone mass, and several studies in Europe have demonstrated its benefit as an adjuvant for fracture healing. Abaloparatide represents a new compound which similarly offers great potential for accelerating fracture healing, especially healing associated with callous formation. This is a randomized, double blind placebo-controlled trial to compare a group of patients being treated for supracondylar distal femur fractures who receive abaloparatide (n=38) with a control group of patients who receive a placebo (n=38).
Read the detailed description
Supracondylar femur fractures in the geriatric population present a unique challenge to the orthopaedic surgeon both in terms of fixation, healing, and final extremity axial alignment. Multiple methods of fixation are well accepted, and each has its own advantages and disadvantages. The common occurrence of periprosthetic supracondylar femur fractures adds another level of complexity, and the universal goal when treating these patients is to obtain and maintain acceptable alignment, allow mobilization and early weight bearing, and achieve union. To a degree, mobilization and weight bearing compete with maintenance of axial alignment, and any final outcome is a race between healing and loss of fixation. As a result, any intervention that can accelerate healing would be of great benefit. As the vast majority of these injuries heal with secondary bone healing (callous), the determination of "healing" is reliably determined using the modified Radiographic Union Score for Tibia Fractures (mRUST), and thus this patient population offers an ideal population in which to evaluate an accelerant of fracture healing.
Pulsed dosing of parathyroid hormone derivatives (Forteo) has been shown to increase bone mass, and several studies in Europe have demonstrated its benefit as an adjuvant for fracture healing. Abaloparatide represents a new compound which similarly offers great potential for accelerating fracture healing, especially healing associated with callous formation. This is a randomized, double blind placebo-controlled trial to compare a group of patients being treated for supracondylar distal femur fractures who receive abaloparatide (n=38) with a control group of patients who receive a placebo (n=38).
- Conditions
- Femoral Fractures
- Being tested
- Abaloparatide, Placebo
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbaloparatideDrug
Abaloparatide will be dispensed as a 30-day supply of disposable pen injections of the standard, FDA approved dosage (80 mcg abaloparatide).
PlaceboDrug
Placebo will be dispensed as a 30-day supply of disposable pen injections.
| Study group | Role | What they receive |
|---|---|---|
| Abaloparatide group | Experimental | Patients in the experimental group will receive abaloparatide after their surgery. Receives: Drug: Abaloparatide |
| Control group | Placebo comparator | Patients in the control group will receive a placebo after their surgery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Radiographic Union Score for Tibia Fractures (mRUST)
degree of callous formation and healing (worst 4 - 16 best)
Measured: 6 weeks
maintenance of axial alignment and loss of fixation
change in the angle between the surface and fixed implant from the baseline radiographs (taken immediately postoperative) and the radiographs taken at 6, 12, and 24 weeks postoperative
Measured: 6 weeks
Secondary outcomes (4)
modified Radiographic Union Score for Tibia Fractures (mRUST)
degree of callous formation and healing (worst 4 - 16 best)
Measured: 12 weeks
modified Radiographic Union Score for Tibia Fractures (mRUST)
degree of callous formation and healing (worst 4 - 16 best)
Measured: 24 weeks
maintenance of axial alignment and loss of fixation
change in the angle between the surface and fixed implant from the baseline radiographs
Measured: 12 weeks
maintenance of axial alignment and loss of fixation
change in the angle between the surface and fixed implant from the baseline radiographs
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study startJun 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Why it stopped: Study withdrawn due to staffing/enrollment related challenges.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Horwitz
- Sponsor type
- University, hospital or other
- Collaborators
- Radius Health, Inc.
- Responsible party
- Sponsor-investigator, Daniel Horwitz, Geisinger Clinic
- Investigators
- Daniel Horwitz, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626141
- Sponsor's protocol ID
- 2020-0544
- Status last verified
- Apr 2024
- First submitted
- 30 Sep 2020
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Healing, Loss of Fixation, and Loss of Alignment in Supracondylar Distal Femur Fractures Among a Geriatric Population Treated With Abaloparatide: A Double-Blind Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT04626141
- Acronym / sponsor ID
- 2020-0544
- Conditions
- Femoral Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn due to staffing/enrollment related challenges.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Daniel HorwitzUniversity, hospital or other
- Collaborators
- Radius Health, Inc.
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 12 Nov 2020 (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.
Supracondylar femur fractures in the geriatric population present a unique challenge to the orthopaedic surgeon both in terms of fixation, healing, and final extremity axial alignment. Pulsed dosing of parathyroid hormone derivatives (Forteo) has been shown to increase bone mass, and several studies in Europe have demonstrated its benefit as an adjuvant for fracture healing. Abaloparatide represents a new compound which similarly offers great potential for accelerating fracture healing, especially healing associated with callous formation. This is a randomized, double blind placebo-controlled trial to compare a group of patients being treated for supracondylar distal femur fractures who receive abaloparatide (n=38) with a control group of patients who receive a placebo (n=38).
Detailed description
Supracondylar femur fractures in the geriatric population present a unique challenge to the orthopaedic surgeon both in terms of fixation, healing, and final extremity axial alignment. Multiple methods of fixation are well accepted, and each has its own advantages and disadvantages. The common occurrence of periprosthetic supracondylar femur fractures adds another level of complexity, and the universal goal when treating these patients is to obtain and maintain acceptable alignment, allow mobilization and early weight bearing, and achieve union. To a degree, mobilization and weight bearing compete with maintenance of axial alignment, and any final outcome is a race between healing and loss of fixation. As a result, any intervention that can accelerate healing would be of great benefit. As the vast majority of these injuries heal with secondary bone healing (callous), the determination of "healing" is reliably determined using the modified Radiographic Union Score for Tibia Fractures (mRUST), and thus this patient population offers an ideal population in which to evaluate an accelerant of fracture healing.
Pulsed dosing of parathyroid hormone derivatives (Forteo) has been shown to increase bone mass, and several studies in Europe have demonstrated its benefit as an adjuvant for fracture healing. Abaloparatide represents a new compound which similarly offers great potential for accelerating fracture healing, especially healing associated with callous formation. This is a randomized, double blind placebo-controlled trial to compare a group of patients being treated for supracondylar distal femur fractures who receive abaloparatide (n=38) with a control group of patients who receive a placebo (n=38).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abaloparatide group | Experimental | Drug: AbaloparatidePatients in the experimental group will receive abaloparatide after their surgery. |
| Control group | Placebo comparator | Drug: PlaceboPatients in the control group will receive a placebo after their surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Subject is ≥ 65 years old
- Subject is willing and able to read, comprehend, and sign the study informed consent form in English prior to study specific procedure
- Subject is being treated for a closed supracondylar distal femur fracture with either a retrograde nail or locked plate
- Subject undergoes open reduction/fixation
Key exclusion criteria (9 listed)
- Subject has open fracture
- Bilateral injury or other lower extremity injury that would affect weight bearing status
- Subject's postoperative radiographs (on day of surgery) indicate failure to achieve axial alignment (more than 10 degrees axial alignment and more than 25% anterior/posterior displacement in lateral view)
- Subject has additional severe traumatic conditions such as closed head injury
- Subject has medical condition or is on medication that may significantly affect healing (i.e. immunosuppressive diseases and drugs)
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 |
|---|---|---|
| AbaloparatideAbaloparatide will be dispensed as a 30-day supply of disposable pen injections of the standard, FDA approved dosage (80 mcg abaloparatide). | Drug | Abaloparatide group |
| PlaceboPlacebo will be dispensed as a 30-day supply of disposable pen injections. | Drug | Control group |
Primary outcome
modified Radiographic Union Score for Tibia Fractures (mRUST)
Time frame: 6 weeks
degree of callous formation and healing (worst 4 - 16 best)
maintenance of axial alignment and loss of fixation
Time frame: 6 weeks
change in the angle between the surface and fixed implant from the baseline radiographs (taken immediately postoperative) and the radiographs taken at 6, 12, and 24 weeks postoperative
4 secondary outcomes
modified Radiographic Union Score for Tibia Fractures (mRUST)
Time frame: 12 weeks
modified Radiographic Union Score for Tibia Fractures (mRUST)
Time frame: 24 weeks
maintenance of axial alignment and loss of fixation
Time frame: 12 weeks
maintenance of axial alignment and loss of fixation
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
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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.
Daniel Horwitz, MD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abaloparatide in people with Femoral Fractures, run by Daniel Horwitz at 1 site in United States.
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 4 inclusion and 9 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: withdrawn, as of the sponsor's last update on 1 May 2024. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
modified Radiographic Union Score for Tibia Fractures (mRUST) (time frame: 6 weeks). The study lists 2 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 1 May 2024.