Supracondylar Distal Femur Fractures and Abaloparatide

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Femoral Fractures
• Intervention / Treatment: Drug: Abaloparatide; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 76
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Daniel Horwitz, MD; Phone Number: 570-271-6541; Email: dshorwitz@geisinger.edu
• Study Contact Backup: Name: Kenneth Sams; Phone Number: 570-214-6178; Email: kbsams@geisinger.edu

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
      • Contact: Kenneth Sams; Phone Number: 570-214-4806; Email: MSKIresearch@geisinger.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abaloparatide group; Patients in the experimental group will receive abaloparatide after their surgery.	Drug: Abaloparatide; Abaloparatide will be dispensed as a 30-day supply of disposable pen injections of the standard, FDA approved dosage (80 mcg abaloparatide).
Placebo Comparator: Control group; Patients in the control group will receive a placebo after their surgery.	Drug: Placebo; Placebo will be dispensed as a 30-day supply of disposable pen injections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified Radiographic Union Score for Tibia Fractures (mRUST)	degree of callous formation and healing (worst 4 - 16 best)	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	6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Daniel Horwitz
• Collaborators: Radius Health, Inc.
• Investigators: Principal Investigator: Daniel Horwitz, MD, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone; Femoral Fractures, Distal; Physiological Effects of Drugs; Bone Density Conservation Agents; Abaloparatide
• Other Study ID Numbers: 2020-0544

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No