Status:
COMPLETED
Effect of Teriparatide on Fracture Healing in Patients With Incomplete Atypical Femur Fractures
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Eli Lilly and Company
Conditions:
Non Displaced Atypical Femoral Fractures
Eligibility:
All Genders
30-100 years
Phase:
PHASE3
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, AF...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01896011
Start Date
July 1 2013
End Date
December 1 2022
Last Update
June 1 2023
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G 2C4