Supracondylar Distal Femur Fractures and Abaloparatide

NCTNCT04626141Other id2020-0544

Open at ClinicalTrials.govAsk about this trial

This trial was withdrawn before it enrolled anyone.

Reason given at the registry: Study withdrawn due to staffing/enrollment related challenges.

Overview

Status: Withdrawn
Phase: Phase 4
Enrollment: 0 participants (actual)
Sponsor: Daniel Horwitz · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: Jun 2024 (estimated)
Primary completion: Jun 2025 (estimated)
Completion: Jun 2025 (estimated)
First posted: 12 Nov 2020
Last update posted: 1 May 2024
Conditions: Femoral Fractures

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202420252026

Ph 4
Supracondylar Distal Femur Fractures and Abaloparatide
NCT04626141
est. Jun 2024 to est. Jun 2025
Withdrawn
Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

AbaloparatideDrug
PlaceboDrug

Arms2

Experimental
Abaloparatide group
Patients in the experimental group will receive abaloparatide after their surgery.
Placebo comparator
Control group
Patients in the control group will receive a placebo after their surgery.

Primary outcomes2

Outcomes the sponsor listed as primary.

modified Radiographic Union Score for Tibia Fractures (mRUST)
Time frame · 6 weeks
Registry description
degree of callous formation and healing (worst 4 - 16 best)
maintenance of axial alignment and loss of fixation
Time frame · 6 weeks
Registry description
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

Secondary outcomes(4)

modified Radiographic Union Score for Tibia Fractures (mRUST)
Time frame · 12 weeks
Registry description
degree of callous formation and healing (worst 4 - 16 best)
modified Radiographic Union Score for Tibia Fractures (mRUST)
Time frame · 24 weeks
Registry description
degree of callous formation and healing (worst 4 - 16 best)
maintenance of axial alignment and loss of fixation
Time frame · 12 weeks
Registry description
change in the angle between the surface and fixed implant from the baseline radiographs
maintenance of axial alignment and loss of fixation
Time frame · 24 weeks
Registry description
change in the angle between the surface and fixed implant from the baseline radiographs

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Subject is ≥ 65 years old 2. Subject is willing and able to read, comprehend, and sign the study informed consent form in English prior to study specific procedure 3. Subject is being treated for a closed supracondylar distal femur fracture with either a retrograde nail or locked plate 4. Subject undergoes open reduction/fixation Exclusion Criteria: 1. Subject has open fracture 2. Bilateral injury or other lower extremity injury that would affect weight bearing status 3. 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) 4. Subject has additional severe traumatic conditions such as closed head injury 5. Subject has medical condition or is on medication that may significantly affect healing (i.e. immunosuppressive diseases and drugs) 6. 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 7. Subject has active or history of hypercalcemia or underlying hypercalcemic disorder, such as primary hyperparathyroidism 8. Subject has active or a history of urolithiasis 9. Subject will have trouble injecting the pen and does not have someone to help them on a daily basis

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