Clinical trial NCT01668589: Observational Study of Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postmenopausal Osteoporosis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2012-08-20
Enrollment: 1501
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Indicated for treatment of osteoporosis in postmenopausal women at increased risk of fractures according to the approved Regional Prescribing Information (eg, EU SmPC in Germany, Austria, Greece and Belgium).
* Enrolled into the study within 4 weeks of receiving their first injection of Prolia® according to the approved Regional Prescribing Information (eg, EU SmPC in Germany, Austria, Greece and Belgium).
* Appropriate written informed consent has been obtained (as required per local country regulations).

Exclusion Criteria:

* Patient is currently enrolled in or has been enrolled within the prior 6 months in a study involving any investigational procedure, device or drug.
* Contraindicated for treatment with Prolia® according to the approved Regional Prescribing Information (eg, EU SmPC in Germany, Austria, Greece and Belgium).
* Participation in ongoing or previous denosumab clinical trials.
* Patient has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the patient to give written informed consent.

Primary outcomes:
measure: Percentage of Participants Persistent With Denosumab Injections at 12 Months and 24 Months
timeFrame: 12 months and 24 months
measure: Percentage of Participants Adherent to Denosumab Injection at 12 Months and 24 Months
timeFrame: 12 months and 24 months
measure: Medication Coverage Ratio (MCR) for Denosumab Injection at 12 Months and 24 Months
timeFrame: From baseline to 12 months and 24 months
Secondary outcomes:
measure: Time to Non-persistence With Denosumab Injection
timeFrame: 24 months
measure: Percentage of Participants Who Received Denosumab Injections Within the Specified Window
timeFrame: 24 months
measure: Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at 24 Months
timeFrame: Baseline and Month 24
measure: Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 24 Months
timeFrame: Baseline and Month 24
measure: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 24 Months
timeFrame: Baseline and Month 24
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Research Site
city: Graz
country: Austria
facility: Research Site
city: Klagenfurt
country: Austria
facility: Research Site
city: Landeck
country: Austria
facility: Research Site
city: Leibnitz
country: Austria
facility: Research Site
city: Lieboch
country: Austria
facility: Research Site
city: Salzburg
country: Austria
facility: Research Site
city: Sankt Stefan
country: Austria
facility: Research Site
city: Voecklabruck
country: Austria
facility: Research Site
city: Voitsberg
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Aalst
country: Belgium
facility: Research Site
city: Aarschot
country: Belgium
facility: Research Site
city: Alsemberg
country: Belgium
facility: Research Site
city: Baisy-Thy
country: Belgium
facility: Research Site
city: Blankenberge
country: Belgium
facility: Research Site
city: Bornem
country: Belgium
facility: Research Site
city: Brain-Le-Comte
country: Belgium
facility: Research Site
city: Brugge
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: ChÃªnÃ©e
country: Belgium
facility: Research Site
city: Dour
country: Belgium
facility: Research Site
city: Eisden Maasmechelen
country: Belgium
facility: Research Site
city: Genk
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Gribomont
country: Belgium
facility: Research Site
city: Grimbergen
country: Belgium
facility: Research Site
city: Haine Saint Paul
country: Belgium
facility: Research Site
city: Halen
country: Belgium
facility: Research Site
city: Ham-Sur-Heure
country: Belgium
facility: Research Site
city: Ham
country: Belgium
facility: Research Site
city: Harelbeke
country: Belgium
facility: Research Site
city: Hasselt
country: Belgium
facility: Research Site
city: Heusden
country: Belgium
facility: Research Site
city: Heusy
country: Belgium
facility: Research Site
city: Hoeilaart
country: Belgium
facility: Research Site
city: Knokke-Heist
country: Belgium
facility: Research Site
city: Kortrijk
country: Belgium
facility: Research Site
city: Kraainem
country: Belgium
facility: Research Site
city: Landen
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Lummen
country: Belgium
facility: Research Site
city: Marchovelette
country: Belgium
facility: Research Site
city: Mont-Godinne
country: Belgium
facility: Research Site
city: Mont-sur-Marchienne
country: Belgium
facility: Research Site
city: Mouscron
country: Belgium
facility: Research Site
city: Natoye
country: Belgium
facility: Research Site
city: Paal-Beringen
country: Belgium
facility: Research Site
city: Retie
country: Belgium
facility: Research Site
city: Seraing
country: Belgium
facility: Research Site
city: Steenokkerzeel
country: Belgium
facility: Research Site
city: Stoumont
country: Belgium
facility: Research Site
city: Thuilles
country: Belgium
facility: Research Site
city: Tongeren
country: Belgium
facility: Research Site
city: Vilvoorde
country: Belgium
facility: Research Site
city: Vlijtingen-Riemst
country: Belgium
facility: Research Site
city: Wetteren
country: Belgium
facility: Research Site
city: Aachen
country: Germany
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Bad Kreuznach
country: Germany
facility: Research Site
city: Bad Reichenhall
country: Germany
facility: Research Site
city: Bammental
country: Germany
facility: Research Site
city: Bautzen
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Cottbus
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: DÃ¼sseldorf
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Freudenstadt
country: Germany
facility: Research Site
city: Friedrichroda
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Hattingen
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Heinsberg
country: Germany
facility: Research Site
city: Herne
country: Germany
facility: Research Site
city: Hettstedt
country: Germany
facility: Research Site
city: Hildesheim
country: Germany
facility: Research Site
city: Immenstadt
country: Germany
facility: Research Site
city: Lahnstein
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Leverkusen
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: MÃ¶nchengladbach-Rheydt
country: Germany
facility: Research Site
city: MÃ¼llheim
country: Germany
facility: Research Site
city: MÃ¼nchen
country: Germany
facility: Research Site
city: MÃ¼nchen
country: Germany
facility: Research Site
city: MÃ¼nchen
country: Germany
facility: Research Site
city: MÃ¼nster
country: Germany
facility: Research Site
city: Neustadt
country: Germany
facility: Research Site
city: Nienburg
country: Germany
facility: Research Site
city: NÃ¼rnbrecht
country: Germany
facility: Research Site
city: OsnabrÃ¼ck
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: SaarbrÃ¼cken
country: Germany
facility: Research Site
city: Stockach
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
city: VÃ¶lklingen
country: Germany
facility: Research Site
city: Wadgassen
country: Germany
facility: Research Site
city: Wittstock
country: Germany
facility: Research Site
city: WÃ¼rzburg
country: Germany
facility: Research Site
city: Zerbst
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Chaidari, Athens
country: Greece
facility: Research Site
city: Chania, Crete
country: Greece
facility: Research Site
city: Heraklion, Crete
country: Greece
facility: Research Site
city: Heraklion
country: Greece
facility: Research Site
city: Levadia
country: Greece
facility: Research Site
city: Maroussi, Athens
country: Greece
facility: Research Site
city: Patra
country: Greece
facility: Research Site
city: Patra
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Fahrleitner-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.