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

• ClinicalTrials.gov Identifier: NCT01896011
• Recruitment Status: Active, not recruiting
• First Posted: July 11, 2013
• Last Update Posted: September 30, 2020
• Sponsor: University Health Network, Toronto
• Collaborators: The Physicians' Services Incorporated Foundation; Eli Lilly and Company
• Information provided by (Responsible Party): University Health Network, Toronto

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.

Condition or disease	Intervention/treatment	Phase
Non Displaced Atypical Femoral Fractures	Biological: Teriparatide 20 mcg; Other: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Teriparatide on Fracture Healing in Patients With Incomplete Atypical Femur Fractures: a Randomized Controlled Trial
• Study Start Date: July 2013
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Teriparatide 20 mcg daily; Teriparatide (Forteo) 20 mcg daily by injection pen for 12-24 months	Biological: Teriparatide 20 mcg; Teriparatide 20 mcg injection pen; Other Name: Brand name Forteo
Placebo Comparator: Placebo; Placebo injection pen identical to active drug injection pen	Other: Placebo; Placebo 20 mcg injection pen

Outcome Measures

Primary Outcome Measures :

1. 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 ]
2. The proportion of patients requiring surgical intervention [ Time Frame: baseline to 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Canada, Ontario

University Health Network

Toronto, Ontario, Canada, M5G 2C4

Sponsors and Collaborators

University Health Network, Toronto

The Physicians' Services Incorporated Foundation

Eli Lilly and Company

Investigators

• Study Director: Angela M Cheung, MD, PhD; University Health Network, Toronto
• Principal Investigator: Lianne E Tile, Md, MEd; University Health Network, Toronto

More Information

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT01896011
• Other Study ID Numbers: TAFF 12-0170; Control # 164050 ( Registry Identifier: Health Canada BGTD )
• First Posted: July 11, 2013
• Last Update Posted: September 30, 2020
• Last Verified: September 2020

Additional relevant MeSH terms:

Fractures, Bone; Femoral Fractures; Wounds and Injuries; Leg Injuries; Teriparatide; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Bone Density Conservation Agents