Roche trials database

Protocol number:

ML19324

Title of Study:

Adherence to once monthly treatment - ATOM

Sponsor:

Roche Norge AS;

Company division:

Pharmaceutical

Product name:

Bonviva/Boniva

Generic name:

ibandronate

Therapeutic area:

• Post-Menopausal Osteoporosis

Clinical study summary:

This randomized, open-label study was designed to study the compliance of females taking once-a-month Bonviva (ibandronate) relative to the kind of reminders/support they were given.

Study center(s):

15 centers in Norway

Phase of development:

IV

Objectives:

The primary study objective was to compare the mean difference from target day for each treatment group.
Secondary objectives were to compare the number of non-compliant patients in each treatment arm; to evaluate patient satisfaction across reminder methods; for patients treated with a bisphosphonate within 6 months prior to inclusion, to evaluate preference for treatment; and to determine the safety of once monthly bisphosphonate treatment.

Methodology:

Patients were randomized into one of 4 groups, providing a) a calendar sticker, b) a letter from the doctor in addition to the sticker, c) a telephone message in addition to the sticker or d) an electronic supporting device in addition to the sticker. Compliance to monthly medication (Bonviva 150mg po) was compared in the 4 groups over a treatment period of 24 weeks.

Number of patients (planned/analyzed):

Planned 180 patients / enrolled 180 patients

Diagnosis and main criteria for inclusion:

Female patients, aged 55 years or older, receiving monthly bisphosphonate treatment.

Test product, dose and mode of administration or test procedure:

Bonviva (ibandronate) 150mg po monthly

Duration of treatment:

6 months

Reference therapy, dose and mode of administration or reference procedure:

N/A

Criteria for evaluation (efficacy, safety):

The primary efficacy parameters were the deviation in days between the target and the actual date of tablet intake and the absolute deviation in days between the planned and the actual date of tablet intake. Secondary efficacy parameters were the number of non-compliant patients, patient rating of supportive method and patient rating of preference for present treatment compared to previous treatment.
Safety parameters were adverse event rate and profile.

Statistical methods:

The primary statistical hypothesis of at least one treatment being different from the others was tested using ANOVA with study group, and the two stratification factors, age and previous bisphosphonate experience, as factors. All tests were performed using two-tailed alternative with a significance level of 5%.
Secondary endpoints of number of compliant patients, patient rating of supportive method and patient rating of preference for present treatment compared to previous treatment was also compared among study groups at a hypothesis generating level. The null hypothesis of no difference between the groups versus at least one difference was tested using contingency tables analysis or similar methods.

Summary (efficacy, safety, other results):

Efficacy: Patients generally took their medication somewhat earlier than targeted, on average less than one day before. The electronic device group generally took their medication somewhat after the target date, but again with less than one day deviance. Mean deviations were generally less than one day for all groups and all periods. The primary analyses showed that none of the approaches to reminding patients differed significantly. Neither age (below or above 67) nor previous experience with bisphosphonates had an effect on the size of the deviation of intake date from target date.
No patients were non-compliant according to the 21-day definition of compliance, but one patient was non-compliant in the e-device group according to the 4-times-7-day deviation. There was no statistically significant difference in compliance among support groups.
The patients scored their satisfaction with the method of notification on a scale of 1 to 6, where 6 was considered ‘best’. There was a significant difference between the reminder methods, p< 0.0001. The Tukey method indicated that the electronic notification method was significantly less appreciated than the other methods.
Patients were asked to rate the study treatment compared to previous bisphosphonate treatment on a scale of “much worse”, “worse”, “the same”, “better” and “much better”, analysed using the values 1, 2, 3, 4 and 5, respectively. No differences between the groups were seen. Among those who had a preference, statistically significantly (p< 0.0001) more patients preferred the present treatment compared to the previous treatment.

Safety: Overall, 49% of the patients reported one or more adverse events and 4.5% had one or more serious adverse events during the study. There was no difference between the groups in terms of the safety profile of Bonviva.

Conclusions:

This study compared 4 different methods of reminding patients to take once-a-month Bonviva medication. There were no significant differences between the groups, in terms of their deviation from the targeted dosing day.
Only one patient (in the electronic notification group) was considered non-compliant. The patient group using the electronic reminder device was significantly less satisfied with the reminder method than the other groups.

Publications (references, if available):

None

Date of report:

13.05.2008

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