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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

Tracking Information
First Submitted Date  ICMJE July 5, 2013
First Posted Date  ICMJE July 11, 2013
Last Update Posted Date September 30, 2020
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2013)
  • 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 ]
  • The proportion of patients requiring surgical intervention [ Time Frame: baseline to 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Teriparatide on Fracture Healing in Patients With Incomplete Atypical Femur Fractures
Official Title  ICMJE Effect of Teriparatide on Fracture Healing in Patients With Incomplete Atypical Femur Fractures: a Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non Displaced Atypical Femoral Fractures
Intervention  ICMJE
  • Biological: Teriparatide 20 mcg
    Teriparatide 20 mcg injection pen
    Other Name: Brand name Forteo
  • Other: Placebo
    Placebo 20 mcg injection pen
Study Arms  ICMJE
  • Active Comparator: Teriparatide 20 mcg daily
    Teriparatide (Forteo) 20 mcg daily by injection pen for 12-24 months
    Intervention: Biological: Teriparatide 20 mcg
  • Placebo Comparator: Placebo
    Placebo injection pen identical to active drug injection pen
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 16, 2019)
34
Original Estimated Enrollment  ICMJE
 (submitted: July 5, 2013)
60
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01896011
Other Study ID Numbers  ICMJE TAFF 12-0170
Control # 164050 ( Registry Identifier: Health Canada BGTD )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE
  • The Physicians' Services Incorporated Foundation
  • Eli Lilly and Company
Investigators  ICMJE
Study Director: Angela M Cheung, MD, PhD University Health Network, Toronto
Principal Investigator: Lianne E Tile, Md, MEd University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP