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

NCT01668589 | Completed Results

• 1 other identifier: 20110126
• Study Type: observational
• Target: 1,501
• Locations: 4 countries
• Sites: 144

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.

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Time to Non-persistence With Denosumab Injection

  24 months

• Percentage of Participants Who Received Denosumab Injections Within the Specified Window

  24 months

• Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at 24 Months

  Baseline and Month 24

• Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 24 Months

  Baseline and Month 24

• Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 24 Months

  Baseline and Month 24

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (144)

Research Site

Graz, 8010, Austria

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Graz, 8036, Austria

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Klagenfurt, 9020, Austria

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Landeck, 6500, Austria

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Leibnitz, Styria, 8430, Austria

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Lieboch, 8501, Austria

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Salzburg, 5020, Austria

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Sankt Stefan, 8511, Austria

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Vienna, 1040, Austria

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Vienna, 1060, Austria

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Vienna, 1070, Austria

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Vienna, 1090, Austria

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Vienna, 1100, Austria

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Vienna, 1160, Austria

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Vienna, 1190, Austria

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Vienna, 1220, Austria

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Vienna, 1230, Austria

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Voitsberg, 8570, Austria

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Vöcklabruck, 4840, Austria

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Aalst, 9300, Belgium

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Aarschot, 3200, Belgium

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Alsemberg, 1652, Belgium

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Baisy-Thy, 1470, Belgium

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Blankenberge, 8370, Belgium

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Bornem, 2880, Belgium

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Brain-Le-Comte, 7090, Belgium

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Bruges, 8310, Belgium

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Brussels, 1050, Belgium

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Brussels, 1070, Belgium

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Chênée, 4032, Belgium

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Dour, 7370, Belgium

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Eisden Maasmechelen, 3630, Belgium

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Genk, 3600, Belgium

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Ghent, 9000, Belgium

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Gribomont, 6887, Belgium

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Grimbergen, 1850, Belgium

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Haine-Saint-Paul, 7100, Belgium

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Halen, 3545, Belgium

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Ham, 3945, Belgium

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Ham-sur-Heure, 6120, Belgium

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Harelbeke, 8530, Belgium

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Hasselt, 3500, Belgium

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Heusden, 9070, Belgium

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Heusy, 4802, Belgium

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Hoeilaart, 1560, Belgium

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Knokke-Heist, 8300, Belgium

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Kortrijk, 8500, Belgium

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Kraainem, 1950, Belgium

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Landen, 3400, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Lummen, 3650, Belgium

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Marchovelette, 5380, Belgium

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Mont-Godinne, 5530, Belgium

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Mont-sur-Marchienne, 6032, Belgium

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Mouscron, 7700, Belgium

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Natoye, 5360, Belgium

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Paal-Beringen, 3583, Belgium

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Retie, 2470, Belgium

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Seraing, 4100, Belgium

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Steenokkerzeel, 1820, Belgium

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Stoumont, 4987, Belgium

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Thuilles, 6536, Belgium

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Tongeren, 3700, Belgium

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Vilvoorde, 1800, Belgium

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Vlijtingen-Riemst, 3770, Belgium

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Wetteren, 9230, Belgium

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Aachen, 52064, Germany

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Augsburg, 86150, Germany

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Bad Kreuznach, 55543, Germany

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Bad Reichenhall, 83453, Germany

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Bammental, 69245, Germany

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Bautzen, 02625, Germany

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Berlin, 10559, Germany

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Berlin, 10717, Germany

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Berlin, 12051, Germany

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Berlin, 14199, Germany

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Cottbus, 03050, Germany

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Düsseldorf, 40223, Germany

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Dresden, 01129, Germany

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Erfurt, 99096, Germany

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Erlangen, 91054, Germany

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Freiburg im Breisgau, 79106, Germany

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Freudenstadt, 72250, Germany

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Friedrichroda, 99894, Germany

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Hamburg, 20354, Germany

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Hamburg, 22143, Germany

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Hamburg, 22415, Germany

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Hanover, 30459, Germany

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Hattingen, 45525, Germany

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Heidelberg, 69120, Germany

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Heinsberg, 52525, Germany

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Herne, 44652, Germany

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Hettstedt, 06333, Germany

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Hildesheim, 31134, Germany

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Immenstadt im Allgäu, 87509, Germany

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Lahnstein, 56112, Germany

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Leipzig, 04109, Germany

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Leipzig, 04299, Germany

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Leverkusen, 51375, Germany

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Marburg, 35043, Germany

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Müllheim, 79379, Germany

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München, 80335, Germany

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München, 80634, Germany

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München, 81675, Germany

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Münster, 48149, Germany

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Mönchengladbach-Rheydt, 41239, Germany

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Nürnbrecht, 51588, Germany

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Neustadt, 31535, Germany

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Nienburg, 31582, Germany

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Osnabrück, 49074, Germany

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Potsdam, 14469, Germany

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Saarbrücken, 66111, Germany

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Stockach, 78333, Germany

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Ulm, 89073, Germany

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Völklingen, 66333, Germany

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Wadgassen, 66787, Germany

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Würzburg, 97074, Germany

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Wittstock, 16909, Germany

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Zerbst, 39261, Germany

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Athens, 11521, Greece

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Athens, 11525, Greece

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Athens, 11526, Greece

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Athens, 11528, Greece

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Athens, 14561, Greece

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Athens, 15562, Greece

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Athens, 15771, Greece

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Athens, 16673, Greece

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Athens, 16674, Greece

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Chaidari, Athens, 12462, Greece

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Chania, Crete, 73136, Greece

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Heraklion, 71110, Greece

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Heraklion, Crete, 71409, Greece

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Livadeia, 32100, Greece

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Maroussi, Athens, 15123, Greece

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Pátrai, 26443, Greece

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Pátrai, 26500, Greece

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Thessaloniki, 54622, Greece

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Thessaloniki, 54635, Greece

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Thessaloniki, 54636, Greece

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Thessaloniki, 55131, Greece

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Thessaloniki, 56403, Greece

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Thessaloniki, 56429, Greece

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Thessaloniki, 57001, Greece

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Related 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.

  PMID: 28643265 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 20, 2012
• Study Start: November 28, 2011
• Primary Completion: August 31, 2015
• Study Completion: August 31, 2015
• Last Updated: January 30, 2018
• Results First Posted: September 20, 2016

Record last verified: 2018-01

Locations

BE (48); GR (24); DE (53); AU (19)