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Effect of Teriparatide on Fracture Healing in Patients With Incomplete Atypical Femur Fractures

Primary Purpose

Non Displaced Atypical Femoral Fractures

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Teriparatide 20 mcg

Placebo

About this trial

This is an interventional treatment trial for Non Displaced Atypical Femoral Fractures

Eligibility Criteria

30 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

i. Female or male; ii. Over the age of 30; iii. Experienced an incomplete AFF that satisfies the diagnostic criteria as set forth by the American Society for Bone and Mineral Research (ASBMR) International Task Force on AFFs:

Atraumatic or low trauma incomplete stress fractures, defined as fractures sustained with minimal force, such as a fall from standing height;
From distal to the lesser trochanter to proximal to the supracondylar flare along the femoral shaft.
Radiographic confirmation of AFF features is required for a definitive diagnosis. Incomplete AFF features include cortical thickening, cortical beaking, and lucency line. Patients with cortical beaking without lucency line can be included.

Exclusion Criteria:

i. Peri-prosthetic fractures, ii. High trauma fractures, iii. Pathological fractures secondary to metastases or metabolic bone diseases other than osteoporosis, iv. Fractures that are not confirmed by radiological investigations, v. Contraindication to use of teriparatide such as:

pregnant or nursing mothers, or women who are planning on pregnancy within 1 year of completing teriparatide therapy,
hypersensitivity to teriparatide,
severe renal impairment,
multiple myeloma,
active cancer in past 5 years (other than non-melanoma skin cancer),
primary hyperparathyroidism,
hypercalcemia,
Paget's disease or other conditions that may increase the risk for osteosarcoma,
Prior radiation therapy involving the skeleton, vi. Concomitant use of other osteoporosis therapies including bisphosphonates or denosumab (except calcitonin).

AFF patients with complete fractures on the contralateral side or patients with secondary osteoporosis will not be excluded.

Sites / Locations

University Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Teriparatide 20 mcg daily

Placebo

Arm Description

Teriparatide (Forteo) 20 mcg daily by injection pen for 12-24 months

Placebo injection pen identical to active drug injection pen

Outcomes

Primary Outcome Measures

Change in the modified The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)of the affected limb (the femur that has the incomplete AFF)

The proportion of patients requiring surgical intervention

Secondary Outcome Measures

Full Information

NCT ID

NCT01896011

First Posted

July 5, 2013

Last Updated

May 30, 2023

Sponsor

University Health Network, Toronto

Collaborators

The Physicians' Services Incorporated Foundation, Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01896011

Brief Title

Effect of Teriparatide on Fracture Healing in Patients With Incomplete Atypical Femur Fractures

Official Title

Effect of Teriparatide on Fracture Healing in Patients With Incomplete Atypical Femur Fractures: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

December 2021 (Actual)

Study Completion Date

December 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

Collaborators

The Physicians' Services Incorporated Foundation, Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Atypical femur (thigh bone) fractures (AFFs) are uncommon low-trauma fractures which often occur without warning, are highly debilitating, and are slow to heal. As physicians learn more about them, AFFs are increasingly being identified prior to a total break. However, there's no evidence on the best way to treat these non-displaced AFFs. One option is teriparatide, an osteoporosis medication that can build new bone. Investigators will conduct a double blind randomized placebo controlled trial to examine whether teriparatide use in AFF patients with an incomplete break will help accelerate fracture healing and prevent surgical intervention. Co-primary outcomes include change in WOMAC scores from baseline to 12 months and number of participants requiring surgical intervention at 12 months. Investigators will recruit 60 women and men over the age of 30 who have experienced an incomplete AFF. Participants will be randomly assigned to either teriparatide (20 mcg/day) or placebo (using an identical injection pen) for up to 2 years. As AFFs are highly debilitating, a trial examining the use of Teriparatide in this population is urgently needed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Displaced Atypical Femoral Fractures

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Teriparatide 20 mcg daily

Arm Type

Active Comparator

Arm Description

Teriparatide (Forteo) 20 mcg daily by injection pen for 12-24 months

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo injection pen identical to active drug injection pen

Intervention Type

Biological

Intervention Name(s)

Teriparatide 20 mcg

Other Intervention Name(s)

Brand name Forteo

Intervention Description

Teriparatide 20 mcg injection pen

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo 20 mcg injection pen

Primary Outcome Measure Information:

Title

Change in the modified The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)of the affected limb (the femur that has the incomplete AFF)

Time Frame

baseline to 12 months

Title

The proportion of patients requiring surgical intervention

Time Frame

baseline to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: i. Female or male; ii. Over the age of 30; iii. Experienced an incomplete AFF that satisfies the diagnostic criteria as set forth by the American Society for Bone and Mineral Research (ASBMR) International Task Force on AFFs: Atraumatic or low trauma incomplete stress fractures, defined as fractures sustained with minimal force, such as a fall from standing height; From distal to the lesser trochanter to proximal to the supracondylar flare along the femoral shaft. Radiographic confirmation of AFF features is required for a definitive diagnosis. Incomplete AFF features include cortical thickening, cortical beaking, and lucency line. Patients with cortical beaking without lucency line can be included. Exclusion Criteria: i. Peri-prosthetic fractures, ii. High trauma fractures, iii. Pathological fractures secondary to metastases or metabolic bone diseases other than osteoporosis, iv. Fractures that are not confirmed by radiological investigations, v. Contraindication to use of teriparatide such as: pregnant or nursing mothers, or women who are planning on pregnancy within 1 year of completing teriparatide therapy, hypersensitivity to teriparatide, severe renal impairment, multiple myeloma, active cancer in past 5 years (other than non-melanoma skin cancer), primary hyperparathyroidism, hypercalcemia, Paget's disease or other conditions that may increase the risk for osteosarcoma, Prior radiation therapy involving the skeleton, vi. Concomitant use of other osteoporosis therapies including bisphosphonates or denosumab (except calcitonin). AFF patients with complete fractures on the contralateral side or patients with secondary osteoporosis will not be excluded.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Angela M Cheung, MD, PhD

Organizational Affiliation

University Health Network, Toronto

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Lianne E Tile, Md, MEd

Organizational Affiliation

University Health Network, Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Health Network

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Effect of Teriparatide on Fracture Healing in Patients With Incomplete Atypical Femur Fractures

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