Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis

November 4, 2022 updated by: Amgen

Prospective Observational Study to Evaluate Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis in Routine Clinical Practice

The objective of this study was to describe persistence with Prolia® 60 mg administered subcutaneously (SC) every 6 months (Q6M) at 12 and 24 months.

Study Overview

Status

Completed

Conditions

Detailed Description

The study was a multi-center, single-arm, prospective, non-interventional observational study in postmenopausal women with osteoporosis who had been treated with Prolia® for osteoporosis in routine clinical practice.

Study Type

Observational

Enrollment (Actual)

935

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

  • Canada
      • Quebec, Canada, G1V 3M7
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada, T2X 3X7
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E1
        • Research Site
      • Victora, British Columbia, Canada, V9A 7N6
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Research Site
      • Winnipeg, Manitoba, Canada, R3T 2E8
        • Research Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 5E8
        • Research Site
      • St. John's, Newfoundland and Labrador, Canada, A1E 2E2
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Research Site
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Research Site
      • Corunna, Ontario, Canada, N0N 1G0
        • Research Site
      • London, Ontario, Canada, N5W 6A2
        • Research Site
      • London, Ontario, Canada, N6A 5G6
        • Research Site
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Research Site
      • Oakville, Ontario, Canada, L6J 1X8
        • Research Site
      • Peterborough, Ontario, Canada, K9H 2P4
        • Research Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Research Site
      • Toronto, Ontario, Canada, M4S 1Y2
        • Research Site
      • Toronto, Ontario, Canada, M3M 3E5
        • Research Site
      • Woodstock, Ontario, Canada, N4S 5P5
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Research Site
      • Montreal, Quebec, Canada, H2L 1S6
        • Research Site
      • Pointe-Claire, Quebec, Canada, H9R 3J1
        • Research Site
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Research Site
      • St. Jean-Sur-Richelieu, Quebec, Canada, J2W 1J1
        • Research Site
      • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
        • Research Site
      • Westmount, Quebec, Canada, H3Z 2P9
        • Research Site
      • Westmout, Quebec, Canada, H3Z 1E5
        • Research Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Research Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Research Site
      • Peoria, Arizona, United States, 85381
        • Research Site
      • Phoenix, Arizona, United States, 85050
        • Research Site
    • California
      • Hemet, California, United States, 92543
        • Research Site
      • Laguna Hills, California, United States, 92653
        • Research Site
      • Los Angeles, California, United States, 90048
        • Research Site
      • Murrieta, California, United States, 92563
        • Research Site
      • Oxnard, California, United States, 93030
        • Research Site
      • Santa Maria, California, United States, 93454
        • Research Site
      • Santa Monica, California, United States, 90404
        • Research Site
      • South Lake Tahoe, California, United States, 96150
        • Research Site
      • Victorville, California, United States, 92395
        • Research Site
    • Colorado
      • Lakewood, Colorado, United States, 80227
        • Research Site
    • Connecticut
      • Trumbull, Connecticut, United States, 06611
        • Research Site
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Research Site
      • Hollywood, Florida, United States, 33021
        • Research Site
      • Jacksonville, Florida, United States, 32258
        • Research Site
      • Kissimmee, Florida, United States, 34741
        • Research Site
      • Pembroke Pines, Florida, United States, 33028
        • Research Site
      • Sebring, Florida, United States, 33870
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Research Site
      • Gainesville, Georgia, United States, 30501
        • Research Site
      • Woodstock, Georgia, United States, 30189
        • Research Site
    • Illinois
      • Alton, Illinois, United States, 62002
        • Research Site
      • Rockford, Illinois, United States, 61103
        • Research Site
    • Iowa
      • Bettendorf, Iowa, United States, 52722
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Research Site
      • East Lansing, Michigan, United States, 48823
        • Research Site
      • Lansing, Michigan, United States, 48910
        • Research Site
    • Minnesota
      • Woodbury, Minnesota, United States, 55125
        • Research Site
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89146
        • Research Site
    • New Jersey
      • Butler, New Jersey, United States, 07405
        • Research Site
      • Dover, New Jersey, United States, 07801
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Research Site
    • New York
      • Brooklyn, New York, United States, 11201
        • Research Site
      • Plainview, New York, United States, 11803
        • Research Site
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Research Site
      • Charlotte, North Carolina, United States, 28210
        • Research Site
      • Tabor City, North Carolina, United States, 28463
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • Ohio
      • Akron, Ohio, United States, 44313
        • Research Site
      • Centerville, Ohio, United States, 45459
        • Research Site
      • Cincinnati, Ohio, United States, 45236
        • Research Site
      • Middletown, Ohio, United States, 45044
        • Research Site
    • Oregon
      • Bend, Oregon, United States, 97701
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Research Site
      • Lansdale, Pennsylvania, United States, 19446
        • Research Site
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Research Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Research Site
    • Texas
      • Austin, Texas, United States, 78731
        • Research Site
      • Southlake, Texas, United States, 76092
        • Research Site
    • Virginia
      • Chesapeake, Virginia, United States, 23321
        • Research Site
      • Midlothian, Virginia, United States, 23114
        • Research Site
      • Winchester, Virginia, United States, 22601
        • Research Site
    • Washington
      • Spokane, Washington, United States, 99204
        • Research Site
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Research Site
    • Wisconsin
      • Glendale, Wisconsin, United States, 53217
        • Research Site
      • Madison, Wisconsin, United States, 53705
        • 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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Postmenoapusal women with osteoporsis. Sampling method is Invitation to Volunteer.

Description

Inclusion Criteria:

  • Enrollment within 4 weeks following administration of the first Prolia® (denosumab 60 mg) injection
  • Received Prolia® subcutaneously for treatment of osteoporosis consistent with local (US/Canada) product label
  • Subject or subject's legally acceptable representative has provided informed consent. Exclusion Criteria:
  • Participation in ongoing or previous denosumab clinical trials
  • Currently enrolled in another investigational device or drug study, or less than 6 months since ending another investigational device or drug study(s), or receiving other investigational agent(s)
  • Contra-indicated for treatment with Prolia® according to the approved applicable local product label (US/Canada)
  • Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject 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 With Persistence With Prolia® at 12 Ponths
Time Frame: 12 months
A participant was considered persistent with Prolia® at 12 months if they received at least 2 Prolia® injections no more than 6 months plus 8 weeks (239 days) apart.
12 months
Percentage of Participants With Persistence With Prolia® at 24 Months
Time Frame: 24 months
A participant was considered persistent with Prolia® at 24 months if they received at least 4 Prolia® injections and the length of time between any 2 consecutive Prolia® injections does not exceed 6 months plus 8 weeks (239 days).
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Non-persistence
Time Frame: 24 months
For non-persistent participants, time to non-persistence was calculated as the time between the date of the first injection and the date of last injection received during the period where the participant was still classified as persistent plus 6 months (183 days).
24 months
Number of Prolia® Injections Received
Time Frame: 24 months
The number of injections that a participant received over 24 months (including the baseline injection) regardless of when the injection was received.
24 months
Percentage of Participants Satisfying Medication-taking Behavior at 12 Months
Time Frame: 12 months
Percentage of participants satisfying medication-taking behavior defined as, following the first Prolia® injection, the participant received a second Prolia® injection and the length of time between the first and the second Prolia® injection did not exceed 6 months with a grace period of ± 4 weeks.
12 months
Percentage of Participants Satisfying Medication-taking Behavior at 24 Months
Time Frame: 24 months
Percentage of participants satisfying medication-taking behavior defined as the participant received all 4 Prolia® injections and the length of time between any 2 consecutive Prolia® injections did not exceed 6 months with a grace period of ± 4 weeks.
24 months

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)

July 6, 2011

Primary Completion (ACTUAL)

April 7, 2014

Study Completion (ACTUAL)

April 14, 2014

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

April 4, 2016

First Posted (ESTIMATE)

April 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 29, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20101218

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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