Study Complete
Sponsor ID
20060232

Denosumab Adherence Preference Satisfaction Study

Sponsor ID
20060232
Clinicaltrials.gov ID
NCT00518531
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective is to evaluate the adherence of subjects to subcutaneous (SC) 60 mg denosumab every 6 months (Q6M) treatment compared to oral 70 mg alendronate once a week (QW) treatment at the end of treatment period 1 (12 months).

Additional Study Details

Phase
Phase 3
Product
denosumab
Type
Interventional
Masking
None (Open Label)
Enrollment
250
Additional Study Details

Protocol Summary

Primary Outcome Measures

Subject adherence to treatment

Timeframe: 1 year of follow-up

Secondary Outcome Measures

Subject compliance to treatment

Timeframe: 1 year of follow-up

Subject persistence to treatment

Timeframe: 1 year of follow-up

Time to non-adherence to the alendronate treatment

Timeframe: 1 year of follow-up

Time to non-compliance to the alendronate treatment

Timeframe: 1 year of follow-up

Time to non-persistence to the alendronate treatment

Timeframe: 1 year of follow-uo

Subject overall satisfaction to the treatment

Timeframe: 1 year of follow-up

Subject Believe in Medication Necessity Score

Timeframe: Month 6

Subject Believe in Medication Concern Score

Timeframe: Month 6

Subject Believe in Medication Preference Score

Timeframe: Month 6

Subject Reported Medication Adherence Rating Scale (MARS)

Timeframe: 1 year of follow-up

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.