The main objective of this observational study was to describe medication-taking behavior of patients treated with denosumab for postmenopausal osteoporosis (PMO) at 12 and 24 months.
The decision to treat patients with denosumab was made independent of and before their enrolment in the study. No study drug was administered as part of the study.
Study Type
OBSERVATIONAL
Enrollment
1,501
Percentage of Participants Persistent With Denosumab Injections at 12 Months and 24 Months
A participant was considered persistent with denosumab at 12 months if they received at least 1 denosumab injection following the pre-enrolment denosumab injection no later than 6 months + 8 weeks (ie, no greater than 239 days apart). A participant was considered persistent with denosumab at 24 months if they received at least 3 denosumab injections following the pre-enrolment denosumab injection, and the length of time between any 2 consecutive denosumab injections did not exceed 6 months + 8 weeks (ie, no greater than 239 days apart).
Time frame: 12 months and 24 months
Percentage of Participants Adherent to Denosumab Injection at 12 Months and 24 Months
A participant was considered adherent to denosumab at 12 months if they received at least 1 denosumab injection over the 12-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart). A participant was considered adherent to denosumab at 24 months if they received at least 3 denosumab injections over the 24-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart).
Time frame: 12 months and 24 months
Medication Coverage Ratio (MCR) for Denosumab Injection at 12 Months and 24 Months
MCR at 12 months was defined as the accumulative number of days covered with denosumab treatment during the first 12 months divided by 366 days, expressed as a percentage. MCR at 24 months was defined as the accumulative number of days covered with denosumab treatment during the first 24 months divided by 732 days, expressed as a percentage. It was assumed that each injection of denosumab treatment provided 6 months of coverage (or 183 days) from the date of injection or until the date of the next injection, whichever comes first. So, a participant who received only 1 injection in the first year would have MCR at 12 months equal to 50%.
Time frame: From baseline to 12 months and 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Graz, Austria
Research Site
Graz, Austria
Research Site
Klagenfurt, Austria
Research Site
Landeck, Austria
Research Site
Leibnitz, Styria, Austria
Research Site
Lieboch, Austria
Research Site
Salzburg, Austria
Research Site
Sankt Stefan, Austria
Research Site
Vienna, Austria
Research Site
Vienna, Austria
...and 134 more locations
Time to Non-persistence With Denosumab Injection
Time to non-persistence for non-persistent patients was calculated as the time between the date of the first denosumab injection and the date of last denosumab injection received during the period where the patient was still classified as persistent, plus 6 months (183 days). Participants were considered persistent at 24 months if they received at least 4 injections, including the baseline injection, with no more than 6 months + 8 weeks apart between any 2 consecutive injections.
Time frame: 24 months
Percentage of Participants Who Received Denosumab Injections Within the Specified Window
The percentage of participants who received 0, 1, 2, or 3 denosumab injections within the specified window (defined by the persistence definition as 6 months + 8 weeks). The number of injections that a participant took during the 2-year period after the first pre-enrolment injection, and that were given within the appropriate window from the previous injection, irrespective of when the previous injection was given. Only the first 3 post-baseline injections are considered.
Time frame: 24 months
Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at 24 Months
Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).
Time frame: Baseline and Month 24
Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 24 Months
Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).
Time frame: Baseline and Month 24
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 24 Months
Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).
Time frame: Baseline and Month 24