Current partner codePEPTIDESDE
NCT04626141·Phase 4·INTERVENTIONAL

Supracondylar Distal Femur Fractures and Abaloparatide

Status

Withdrawn

Phase

Phase 4

Enrollment

0

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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).

Full 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).

Interventions

Treatment arms and agents.

DRUG

Abaloparatide

Abaloparatide will be dispensed as a 30-day supply of disposable pen injections of the standard, FDA approved dosage (80 mcg abaloparatide).

DRUG

Placebo

Placebo will be dispensed as a 30-day supply of disposable pen injections.

Timeline

From registration to results.

  1. First posted

    Nov 12, 2020

  2. Study start

    Jun 2024

  3. Primary completion

    Jun 2025

  4. Study completion

    Jun 2025

  5. Results posted

    Not reported

  6. Registry updated

    May 1, 2024

Outcomes

What the study measures.

Primary outcomes

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

Secondary outcomes

modified Radiographic Union Score for Tibia Fractures (mRUST)

Time frame · 12 weeks

degree of callous formation and healing (worst 4 - 16 best)

modified Radiographic Union Score for Tibia Fractures (mRUST)

Time frame · 24 weeks

degree of callous formation and healing (worst 4 - 16 best)

maintenance of axial alignment and loss of fixation

Time frame · 12 weeks

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

change in the angle between the surface and fixed implant from the baseline radiographs

Eligibility

Who can take part.

Minimum age
65 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Geisinger Medical Center

Danville, Pennsylvania, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Abaloparatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.