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


METHODS
This was an eight week, single-arm, multicenter, open-label clinical trial. Patients received teriparatide 20 microg/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 > or =8 weeks, including uninterrupted use for four weeks before enrollment.


BACKGROUND
ClinicalTrials.gov, NCT00577863.


METHODS
The primary objective was to detect common complaints (> or =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 > or =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.
Dore
Robin K
RK
Robin K Dore MD, Inc., 18102 Irvine Boulevard, Suite 104, Tustin, CA 92780-3423, USA. rkdmail@sbcglobal.net
Feldman
Robert G
RG
Taylor
Kathleen A
KA
See
Kyoungah
K
Dalsky
Gail P
GP
Warner
Margaret R
MR
D000368:Aged; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D008297:Male; D010024:Osteoporosis / Q000188:drug therapy*; D011446:Prospective Studies; D019379:Teriparatide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D050071:Bone Density Conservation Agents; D019379:Teriparatide