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

Postmenopausal Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668589
• Other study ID #: 20110126
• Status: Completed
• Phase: N/A
• First received: August 16, 2012
• Last updated: January 5, 2018
• Start date: November 28, 2011
• Est. completion date: August 31, 2015

Study information

• Verified date: January 2018
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1501
• Est. completion date: August 31, 2015
• Est. primary completion date: August 31, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Locations

Country	Name	City	State
Austria	Research Site	Graz
Austria	Research Site	Graz
Austria	Research Site	Klagenfurt
Austria	Research Site	Landeck
Austria	Research Site	Leibnitz
Austria	Research Site	Lieboch
Austria	Research Site	Salzburg
Austria	Research Site	Sankt Stefan
Austria	Research Site	Voecklabruck
Austria	Research Site	Voitsberg
Austria	Research Site	Wien
Austria	Research Site	Wien
Austria	Research Site	Wien
Austria	Research Site	Wien
Austria	Research Site	Wien
Austria	Research Site	Wien
Austria	Research Site	Wien
Austria	Research Site	Wien
Austria	Research Site	Wien
Belgium	Research Site	Aalst
Belgium	Research Site	Aarschot
Belgium	Research Site	Alsemberg
Belgium	Research Site	Baisy-Thy
Belgium	Research Site	Blankenberge
Belgium	Research Site	Bornem
Belgium	Research Site	Brain-Le-Comte
Belgium	Research Site	Brugge
Belgium	Research Site	Brussels
Belgium	Research Site	Bruxelles
Belgium	Research Site	Chênée
Belgium	Research Site	Dour
Belgium	Research Site	Eisden Maasmechelen
Belgium	Research Site	Genk
Belgium	Research Site	Gent
Belgium	Research Site	Gribomont
Belgium	Research Site	Grimbergen
Belgium	Research Site	Haine Saint Paul
Belgium	Research Site	Halen
Belgium	Research Site	Ham
Belgium	Research Site	Ham-Sur-Heure
Belgium	Research Site	Harelbeke
Belgium	Research Site	Hasselt
Belgium	Research Site	Heusden
Belgium	Research Site	Heusy
Belgium	Research Site	Hoeilaart
Belgium	Research Site	Knokke-Heist
Belgium	Research Site	Kortrijk
Belgium	Research Site	Kraainem
Belgium	Research Site	Landen
Belgium	Research Site	Leuven
Belgium	Research Site	Liege
Belgium	Research Site	Lummen
Belgium	Research Site	Marchovelette
Belgium	Research Site	Mont-Godinne
Belgium	Research Site	Mont-sur-Marchienne
Belgium	Research Site	Mouscron
Belgium	Research Site	Natoye
Belgium	Research Site	Paal-Beringen
Belgium	Research Site	Retie
Belgium	Research Site	Seraing
Belgium	Research Site	Steenokkerzeel
Belgium	Research Site	Stoumont
Belgium	Research Site	Thuilles
Belgium	Research Site	Tongeren
Belgium	Research Site	Vilvoorde
Belgium	Research Site	Vlijtingen-Riemst
Belgium	Research Site	Wetteren
Germany	Research Site	Aachen
Germany	Research Site	Augsburg
Germany	Research Site	Bad Kreuznach
Germany	Research Site	Bad Reichenhall
Germany	Research Site	Bammental
Germany	Research Site	Bautzen
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Cottbus
Germany	Research Site	Düsseldorf
Germany	Research Site	Dresden
Germany	Research Site	Erfurt
Germany	Research Site	Erlangen
Germany	Research Site	Freiburg
Germany	Research Site	Freudenstadt
Germany	Research Site	Friedrichroda
Germany	Research Site	Hamburg
Germany	Research Site	Hamburg
Germany	Research Site	Hamburg
Germany	Research Site	Hannover
Germany	Research Site	Hattingen
Germany	Research Site	Heidelberg
Germany	Research Site	Heinsberg
Germany	Research Site	Herne
Germany	Research Site	Hettstedt
Germany	Research Site	Hildesheim
Germany	Research Site	Immenstadt
Germany	Research Site	Lahnstein
Germany	Research Site	Leipzig
Germany	Research Site	Leipzig
Germany	Research Site	Leverkusen
Germany	Research Site	Mönchengladbach-Rheydt
Germany	Research Site	Müllheim
Germany	Research Site	München
Germany	Research Site	München
Germany	Research Site	München
Germany	Research Site	Münster
Germany	Research Site	Marburg
Germany	Research Site	Nürnbrecht
Germany	Research Site	Neustadt
Germany	Research Site	Nienburg
Germany	Research Site	Osnabrück
Germany	Research Site	Potsdam
Germany	Research Site	Saarbrücken
Germany	Research Site	Stockach
Germany	Research Site	Ulm
Germany	Research Site	Völklingen
Germany	Research Site	Würzburg
Germany	Research Site	Wadgassen
Germany	Research Site	Wittstock
Germany	Research Site	Zerbst
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Chaidari, Athens
Greece	Research Site	Chania, Crete
Greece	Research Site	Heraklion
Greece	Research Site	Heraklion, Crete
Greece	Research Site	Levadia
Greece	Research Site	Maroussi, Athens
Greece	Research Site	Patra
Greece	Research Site	Patra
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Greece, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 months and 24 months
Primary	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).	12 months and 24 months
Primary	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%.	From baseline to 12 months and 24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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).	Baseline and Month 24
Secondary	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).	Baseline and Month 24
Secondary	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).	Baseline and Month 24

External Links

•   AmgenTrials clinical trials website