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

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

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

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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

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896011


Locations
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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
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Study Director: Angela M Cheung, MD, PhD University Health Network, Toronto
Principal Investigator: Lianne E Tile, Md, MEd University Health Network, Toronto
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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    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries
Teriparatide
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents