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

January 5, 2018 updated by: Amgen

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1501

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Research Site
      • Graz, Austria, 8010
        • Research Site
      • Klagenfurt, Austria, 9020
        • Research Site
      • Landeck, Austria, 6500
        • Research Site
      • Leibnitz, Austria, 8430
        • Research Site
      • Lieboch, Austria, 8501
        • Research Site
      • Salzburg, Austria, 5020
        • Research Site
      • Sankt Stefan, Austria, 8511
        • Research Site
      • Voecklabruck, Austria, 4840
        • Research Site
      • Voitsberg, Austria, 8570
        • Research Site
      • Wien, Austria, 1090
        • Research Site
      • Wien, Austria, 1220
        • Research Site
      • Wien, Austria, 1160
        • Research Site
      • Wien, Austria, 1100
        • Research Site
      • Wien, Austria, 1060
        • Research Site
      • Wien, Austria, 1190
        • Research Site
      • Wien, Austria, 1040
        • Research Site
      • Wien, Austria, 1070
        • Research Site
      • Wien, Austria, 1230
        • Research Site
  • Belgium
      • Aalst, Belgium, 9300
        • Research Site
      • Aarschot, Belgium, 3200
        • Research Site
      • Alsemberg, Belgium, 1652
        • Research Site
      • Baisy-Thy, Belgium, 1470
        • Research Site
      • Blankenberge, Belgium, 8370
        • Research Site
      • Bornem, Belgium, 2880
        • Research Site
      • Brain-Le-Comte, Belgium, 7090
        • Research Site
      • Brugge, Belgium, 8310
        • Research Site
      • Brussels, Belgium, 1050
        • Research Site
      • Bruxelles, Belgium, 1070
        • Research Site
      • Chênée, Belgium, 4032
        • Research Site
      • Dour, Belgium, 7370
        • Research Site
      • Eisden Maasmechelen, Belgium, 3630
        • Research Site
      • Genk, Belgium, 3600
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
      • Gribomont, Belgium, 6887
        • Research Site
      • Grimbergen, Belgium, 1850
        • Research Site
      • Haine Saint Paul, Belgium, 7100
        • Research Site
      • Halen, Belgium, 3545
        • Research Site
      • Ham, Belgium, 3945
        • Research Site
      • Ham-Sur-Heure, Belgium, 6120
        • Research Site
      • Harelbeke, Belgium, 8530
        • Research Site
      • Hasselt, Belgium, 3500
        • Research Site
      • Heusden, Belgium, 9070
        • Research Site
      • Heusy, Belgium, 4802
        • Research Site
      • Hoeilaart, Belgium, 1560
        • Research Site
      • Knokke-Heist, Belgium, 8300
        • Research Site
      • Kortrijk, Belgium, 8500
        • Research Site
      • Kraainem, Belgium, 1950
        • Research Site
      • Landen, Belgium, 3400
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Liege, Belgium, 4000
        • Research Site
      • Lummen, Belgium, 3650
        • Research Site
      • Marchovelette, Belgium, 5380
        • Research Site
      • Mont-Godinne, Belgium, 5530
        • Research Site
      • Mont-sur-Marchienne, Belgium, 6032
        • Research Site
      • Mouscron, Belgium, 7700
        • Research Site
      • Natoye, Belgium, 5360
        • Research Site
      • Paal-Beringen, Belgium, 3583
        • Research Site
      • Retie, Belgium, 2470
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      • Seraing, Belgium, 4100
        • Research Site
      • Steenokkerzeel, Belgium, 1820
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      • Stoumont, Belgium, 4987
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      • Thuilles, Belgium, 6536
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      • Tongeren, Belgium, 3700
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      • Vilvoorde, Belgium, 1800
        • Research Site
      • Vlijtingen-Riemst, Belgium, 3770
        • Research Site
      • Wetteren, Belgium, 9230
        • Research Site
  • Germany
      • Aachen, Germany, 52064
        • Research Site
      • Augsburg, Germany, 86150
        • Research Site
      • Bad Kreuznach, Germany, 55543
        • Research Site
      • Bad Reichenhall, Germany, 83453
        • Research Site
      • Bammental, Germany, 69245
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      • Bautzen, Germany, 02625
        • Research Site
      • Berlin, Germany, 10717
        • Research Site
      • Berlin, Germany, 10559
        • Research Site
      • Berlin, Germany, 12051
        • Research Site
      • Berlin, Germany, 14199
        • Research Site
      • Cottbus, Germany, 03050
        • Research Site
      • Dresden, Germany, 01129
        • Research Site
      • Düsseldorf, Germany, 40223
        • Research Site
      • Erfurt, Germany, 99096
        • Research Site
      • Erlangen, Germany, 91054
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      • Freiburg, Germany, 79106
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      • Freudenstadt, Germany, 72250
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      • Friedrichroda, Germany, 99894
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      • Hamburg, Germany, 20354
        • Research Site
      • Hamburg, Germany, 22143
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      • Hamburg, Germany, 22415
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      • Hannover, Germany, 30459
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      • Hattingen, Germany, 45525
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      • Heidelberg, Germany, 69120
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      • Heinsberg, Germany, 52525
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      • Herne, Germany, 44652
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      • Hettstedt, Germany, 06333
        • Research Site
      • Hildesheim, Germany, 31134
        • Research Site
      • Immenstadt, Germany, 87509
        • Research Site
      • Lahnstein, Germany, 56112
        • Research Site
      • Leipzig, Germany, 04109
        • Research Site
      • Leipzig, Germany, 04299
        • Research Site
      • Leverkusen, Germany, 51375
        • Research Site
      • Marburg, Germany, 35043
        • Research Site
      • Mönchengladbach-Rheydt, Germany, 41239
        • Research Site
      • Müllheim, Germany, 79379
        • Research Site
      • München, Germany, 80335
        • Research Site
      • München, Germany, 81675
        • Research Site
      • München, Germany, 80634
        • Research Site
      • Münster, Germany, 48149
        • Research Site
      • Neustadt, Germany, 31535
        • Research Site
      • Nienburg, Germany, 31582
        • Research Site
      • Nürnbrecht, Germany, 51588
        • Research Site
      • Osnabrück, Germany, 49074
        • Research Site
      • Potsdam, Germany, 14469
        • Research Site
      • Saarbrücken, Germany, 66111
        • Research Site
      • Stockach, Germany, 78333
        • Research Site
      • Ulm, Germany, 89073
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      • Völklingen, Germany, 66333
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      • Wadgassen, Germany, 66787
        • Research Site
      • Wittstock, Germany, 16909
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      • Würzburg, Germany, 97074
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      • Zerbst, Germany, 39261
        • Research Site
  • Greece
      • Athens, Greece, 11528
        • Research Site
      • Athens, Greece, 16673
        • Research Site
      • Athens, Greece, 11521
        • Research Site
      • Athens, Greece, 11526
        • Research Site
      • Athens, Greece, 14561
        • Research Site
      • Athens, Greece, 11525
        • Research Site
      • Athens, Greece, 15562
        • Research Site
      • Athens, Greece, 15771
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      • Athens, Greece, 16674
        • Research Site
      • Chaidari, Athens, Greece, 12462
        • Research Site
      • Chania, Crete, Greece, 73136
        • Research Site
      • Heraklion, Greece, 71110
        • Research Site
      • Heraklion, Crete, Greece, 71409
        • Research Site
      • Levadia, Greece, 32100
        • Research Site
      • Maroussi, Athens, Greece, 15123
        • Research Site
      • Patra, Greece, 26500
        • Research Site
      • Patra, Greece, 26443
        • Research Site
      • Thessaloniki, Greece, 54622
        • Research Site
      • Thessaloniki, Greece, 54636
        • Research Site
      • Thessaloniki, Greece, 56429
        • Research Site
      • Thessaloniki, Greece, 56403
        • Research Site
      • Thessaloniki, Greece, 54635
        • Research Site
      • Thessaloniki, Greece, 55131
        • Research Site
      • Thessaloniki, Greece, 57001
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months and 24 months
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).
12 months and 24 months
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%.
From baseline to 12 months and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Non-persistence With Denosumab Injection
Time Frame: 24 months
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
Percentage of Participants Who Received Denosumab Injections Within the Specified Window
Time Frame: 24 months
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
Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at 24 Months
Time Frame: Baseline and Month 24
Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).
Baseline and Month 24
Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 24 Months
Time Frame: Baseline and Month 24
Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).
Baseline and Month 24
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 24 Months
Time Frame: Baseline and Month 24
Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).
Baseline and Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2011

Primary Completion (Actual)

August 31, 2015

Study Completion (Actual)

August 31, 2015

Study Registration Dates

First Submitted

August 16, 2012

First Submitted That Met QC Criteria

August 16, 2012

First Posted (Estimate)

August 20, 2012

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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