Patient experience with a new teriparatide delivery device

Abstract

Objective:

To determine functionality and acceptability of a new teriparatide (Forteo, Eli Lilly and Company, Indianapolis, IN, USA) delivery device by patients with osteoporosis.

Research design and methods:

This was an eight week, single-arm, multicenter, open-label clinical trial. Patients received teriparatide 20 µg/day by subcutaneous injection using a new delivery device. Men and postmenopausal women with osteoporosis at high risk for fracture were stratified to Current User (n = 92) or Not Current User (n = 107) groups. Current Users had used the original delivery device for ≥8 weeks, including uninterrupted use for four weeks before enrollment.

Clinical trial registration:

ClinicalTrials.gov, NCT00577863.

Main outcome measures:

The primary objective was to detect common complaints (≥3% for all patients) regarding the functionality and acceptability of the new device. Complaints were categorized as functional (e.g., malfunction), nonfunctional (e.g., size), or user manual. Secondary objectives included questionnaire assessment of preference of the new versus original device, features of the new delivery device, and analysis of adverse events.

Results:

A total of 31 patients (16%) reported 47 complaints (four functional, 27 nonfunctional, and 16 user manual). There were two common complaints: device size (4.0%) and lack of information on alcohol swabs (3.5%). Overall, patients agreed that the new device was easy to use (99.5%), easy to learn to use (99%), easy to attach a needle (97%), easy to hold while injecting (95%), and that it reduced their reluctance to take injections (90%). Most Current Users (92%) preferred the new delivery device over the original device. Adverse events reported by ≥2% of patients were upper respiratory infection (3.5%), urinary tract infection (2%), influenza (2%), and headache (2%). Limitations include the one-arm study design and the short (eight week) duration of the study.

Conclusions:

Patients found the new teriparatide delivery device easy to use and Current Users preferred the new delivery device over the original device.

Keywords: :

• Delivery device
• Osteoporosis
• Preference
• Teriparatide

Transparency

Declaration of funding

This study was supported by Eli Lilly and Company.

Declaration of financial/ other relationships

R.K.D. and R.G.F. have disclosed that they are both on the speakers’ bureau, are consultants/advisors for, and have received research grants from Eli Lilly and Company. K.A.T., K.S., G.P.D., and M.R.W. have disclosed that they are employees and stockholders of Eli Lilly and Company.

All peer reviewers receive honoraria from CMRO for their review work. Reviewers 1 and 2 have no relevant financial relationships to disclose.

Acknowledgment

The authors would like to thank Dr Aijun Gao for her data management and statistical analyses support. The authors would also like to thank the study investigators: Robert Busch, Albany, NY; John Dean, Asheville, NC; Robin K. Dore, Tustin, CA; Robert G. Feldman, Laguna Hills, CA; Maria Guoth, Trumball, CT; James Jakes, Montgomery, AL; Stuart Kramer, Danville, VA; Michael Lovy, Tacoma, WA; Christopher Recknor, Gainsville, GA; Robert Rosenberg, Wheaton, MD; Wassim Saikali, Beckley, WV; Joy Schectman, Peoria, AZ; Anthony Sebba, Palm Harbor, FL; William Shergy, Huntsville, AL; Stuart Silverman, Beverly Hills, CA; Jill Vargo, Asheville, NC; Nelson Watts, Cincinnati, OH; Michael Weitz, South Miami, FL; Grattan Woodson III, Decatur, GA.