Post-surgical Outcomes With Anabolic Agent Use in High-risk Ankle Fractures: A Pilot RCT

NCT06303284 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: Pending
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

As the global population ages and the prevalence of poor bone health increases among older patients with ankle fractures, so does the risk of post-surgical complications. Prevention of post-surgical complications is of paramount importance to reducing morbidity, mortality, and healthcare costs. There is growing evidence to support the use of bone-building medications, such as Teriparatide, in patients who have delayed fracture healing or non-unions; however, these medications have yet to be investigated in elderly patients with ankle fractures at high risk for delayed fracture healing and post-operative complications. This project aims to assess the safety and efficacy of short-term Teriparatide use in improving outcomes in a population most likely to suffer post-operative complications. The proposed study is a pilot randomized controlled trial (RCT) with patients 60 years or older with an additional risk factor for delayed healing (i.e., osteoporosis, diabetes, vascular disease) who require ankle fracture surgery. Participants will be randomized to receive the study medication (Teriparatide) or placebo for three months. The primary objective of this study is to acquire vital data (i.e., recruitment rates, follow-up rates, adherence to treatment assignment) required to determine the feasibility of a full-scale multi-centre RCT. Additional aims are to evaluate repeat surgery, complications, time-to-union, and 90-day mortality. A complete a socio-economic and feasibility analysis will be completed. This study will evaluate the novel clinical approach of augmenting surgical fixation with a medication to build bone density and strength, thereby improving bone health, preventing complications, and improving outcomes. This study will also inform planning for a larger clinical trial to reduce the morbidity, mortality, and cost associated with complications in this high-risk population.

Conditions

Ankle Fractures

Outcome Measures

Primary Outcomes (1)

• Participant recruitment rate

  Estimate of the mean monthly recruitment rate across participating sites

  2 years

Secondary Outcomes (11)

• Incidence of composite measure of complications

  3 month after surgery

• Adverse events

  3 month after surgery

• modified Radiological Union Scale for Tibia [RUST] score),

  2 week, 4 week, 2 months, 3 months, 4 months, 5 months, 6 months post operative.

• Olerud Molander Score

  within 48 hours of surgery, 3 month and 6 months after surgery.

• EuroQol five dimensions [EQ-5D]

  within 48 hours of surgery, 3 month and 6 months after surgery.

Study Arms (2)

Teriparatide

EXPERIMENTAL

20 µg subcutaneous Teriparatide injection once daily for 3 months in the post-operative ankle fracture population.

Drug: subcutaneous Teriparatide injection

placebo

SHAM COMPARATOR

20 µg subcutaneous saline placebo injection once daily for 3 months in the post-operative ankle fracture population.

Other: placebo

Interventions

subcutaneous Teriparatide injection DRUG

20 µg subcutaneous (SC) Teriparatide injection

Also known as: Teriparatide

Teriparatide

placebo OTHER

placebo 20 µg subcutaneous saline placebo injection once daily for 3 months in the post-operative ankle fracture population.

placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Our study will include men and women over 60 years of age presenting to the emergency department with low energy ankle fractures (fall from standing height) requiring surgical treatment and who have one or more of the following risk factors, diabetes, osteoporosis, renal disease, steroid use, smoking history, peripheral neuropathy and/or vascular disease.

You may not qualify if:

• Individuals will be excluded if they have received previous Teriparatide therapy, or they have hypercalcemia or hyperparathyroidism, as these are precautions to the use of Teriparatide.

Sponsors & Collaborators

• University of Calgary: lead

MeSH Terms

Conditions

Ankle Fractures

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Prism S Schneider

CONTACT

403-944-4518; prism.schneider@gmail.com

Jessica Duong

CONTACT

403-220-3366; jduong@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 18, 2024

Record last verified: 2024-03