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| ID | Type | Description | Link |
|---|---|---|---|
| Control # 164050 | Registry Identifier | Health Canada BGTD |
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| Name | Class |
|---|---|
| The Physicians' Services Incorporated Foundation | OTHER |
| Eli Lilly and Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teriparatide 20 mcg daily | Active Comparator | Teriparatide (Forteo) 20 mcg daily by injection pen for 12-24 months |
|
| Placebo | Placebo Comparator | Placebo injection pen identical to active drug injection pen |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide 20 mcg | Biological | Teriparatide 20 mcg injection pen |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the modified The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)of the affected limb (the femur that has the incomplete AFF) | baseline to 12 months | |
| The proportion of patients requiring surgical intervention | baseline to 12 months |
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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:
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:
AFF patients with complete fractures on the contralateral side or patients with secondary osteoporosis will not be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Angela M Cheung, MD, PhD | University Health Network, Toronto | Study Director |
| Lianne E Tile, Md, MEd | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Toronto | Ontario | M5G 2C4 | Canada |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Placebo | Other | Placebo 20 mcg injection pen |
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| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |