Supracondylar Distal Femur Fractures and Abaloparatide

NCT04626141 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2020-0544
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• modified Radiographic Union Score for Tibia Fractures (mRUST)

  12 weeks

• modified Radiographic Union Score for Tibia Fractures (mRUST)

  24 weeks

• maintenance of axial alignment and loss of fixation

  12 weeks

• maintenance of axial alignment and loss of fixation

  24 weeks

Study Arms (2)

Abaloparatide group

EXPERIMENTAL

Patients in the experimental group will receive abaloparatide after their surgery.

Drug: Abaloparatide

Control group

PLACEBO COMPARATOR

Patients in the control group will receive a placebo after their surgery.

Drug: Placebo

Interventions

Abaloparatide DRUG

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

Abaloparatide group

Placebo DRUG

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

Control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Daniel Horwitz: lead
• Radius Health, Inc.: collaborator

Study Sites (1)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Femoral Fractures

Interventions

abaloparatide

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Daniel Horwitz, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: November 12, 2020
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

US (1)