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

NCT ID: NCT01896011

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2022-12-31

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.

Conditions

Non Displaced Atypical Femoral Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Teriparatide 20 mcg daily

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

Group Type: ACTIVE_COMPARATOR

Teriparatide 20 mcg

Intervention Type: BIOLOGICAL

Teriparatide 20 mcg injection pen

Placebo

Placebo injection pen identical to active drug injection pen

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo 20 mcg injection pen

Interventions

Teriparatide 20 mcg

Teriparatide 20 mcg injection pen

Intervention Type: BIOLOGICAL

Placebo

Placebo 20 mcg injection pen

Intervention Type: OTHER

Other Intervention Names

Brand name Forteo

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:

1. Atraumatic or low trauma incomplete stress fractures, defined as fractures sustained with minimal force, such as a fall from standing height;

2. From distal to the lesser trochanter to proximal to the supracondylar flare along the femoral shaft.

3. 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:

1. pregnant or nursing mothers, or women who are planning on pregnancy within 1 year of completing teriparatide therapy,

2. hypersensitivity to teriparatide,

3. severe renal impairment,

4. multiple myeloma,

5. active cancer in past 5 years (other than non-melanoma skin cancer),

6. primary hyperparathyroidism,

7. hypercalcemia,

8. Paget's disease or other conditions that may increase the risk for osteosarcoma,

9. 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angela M Cheung, MD, PhD

Role: STUDY_DIRECTOR

University Health Network, Toronto

Lianne E Tile, Md, MEd

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

Control # 164050

Identifier Type: REGISTRY

Identifier Source: secondary_id

12-0170

Identifier Type: -

Identifier Source: org_study_id