Observational Study of Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Prospective Observational Study to Evaluate Medication-taking Behavior With Denosumab (Prolia) and Patient Characteristics in Postmenopausal Women With Osteoporosis in Routine Clinical Practice in Germany, Austria, Greece and Belgium

ClinicalTrials.gov ID

NCT01668589

Acronym / sponsor ID

20110126

Conditions

Postmenopausal Osteoporosis

Study type

Observational

Recruitment status

Completed

Enrolment

1,501 participants (actual)

Lead sponsor

AmgenIndustry (pharma, biotech, devices)

Study start

28 Nov 2011 (actual)

Primary completion

31 Aug 2015 (actual)

Study completion

31 Aug 2015 (actual)

First posted

20 Aug 2012 (estimated)

Results

Posted 20 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Who may qualify

Sex

Female only

Healthy volunteers

Not accepted

Age groups

Child, Adult, Older adult

Study population

Postmenopausal women indicated for treatment of osteoporosis at increased risk of fractures according to the approval regional prescribing information, e.g. EU SmPC

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. Percentage of Participants Persistent With Denosumab Injections at 12 Months and 24 Months

   Time frame: 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).

2. Percentage of Participants Adherent to Denosumab Injection at 12 Months and 24 Months

   Time frame: 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).

3. Medication Coverage Ratio (MCR) for Denosumab Injection at 12 Months and 24 Months

   Time frame: From baseline to 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%.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Background: PubMed 28643265Fahrleitner-Pammer A, Papaioannou N, Gielen E, Feudjo Tepie M, Toffis C, Frieling I, Geusens P, Makras P, Boschitsch E, Callens J, Anastasilakis AD, Niedhart C, Resch H, Kalouche-Khalil L, Hadji P. Factors associated with high 24-month persistence with denosumab: results of a real-world, non-interventional study of women with postmenopausal osteoporosis in Germany, Austria, Greece, and Belgium. Arch Osteoporos. 2017 Dec;12(1):58. doi: 10.1007/s11657-017-0351-2. Epub 2017 Jun 22.
• AmgenTrials clinical trials websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

144 sites in 4 countries: see every site and its status.