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

NCT ID: NCT02732210

Last Updated: 2022-11-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

935 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-06

Study Completion Date

2014-04-14

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteoporosis, Age-Related

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Research Site

Birmingham, Alabama, United States

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Chandler, Arizona, United States

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Hemet, California, United States

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Laguna Hills, California, United States

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Los Angeles, California, United States

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Murrieta, California, United States

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Oxnard, California, United States

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Santa Maria, California, United States

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Santa Monica, California, United States

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South Lake Tahoe, California, United States

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Victorville, California, United States

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Lakewood, Colorado, United States

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Trumbull, Connecticut, United States

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Fort Myers, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Pembroke Pines, Florida, United States

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Sebring, Florida, United States

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Atlanta, Georgia, United States

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Gainesville, Georgia, United States

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Woodstock, Georgia, United States

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Alton, Illinois, United States

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Rockford, Illinois, United States

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Bettendorf, Iowa, United States

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Detroit, Michigan, United States

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East Lansing, Michigan, United States

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Lansing, Michigan, United States

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Woodbury, Minnesota, United States

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Springfield, Missouri, United States

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Las Vegas, Nevada, United States

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Butler, New Jersey, United States

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Dover, New Jersey, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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Plainview, New York, United States

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Asheboro, North Carolina, United States

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Charlotte, North Carolina, United States

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Tabor City, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Centerville, Ohio, United States

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Cincinnati, Ohio, United States

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Middletown, Ohio, United States

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Bend, Oregon, United States

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Duncansville, Pennsylvania, United States

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Lansdale, Pennsylvania, United States

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Myrtle Beach, South Carolina, United States

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Jackson, Tennessee, United States

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Austin, Texas, United States

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Southlake, Texas, United States

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Chesapeake, Virginia, United States

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Midlothian, Virginia, United States

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Winchester, Virginia, United States

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Spokane, Washington, United States

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Charleston, West Virginia, United States

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Glendale, Wisconsin, United States

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Madison, Wisconsin, United States

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Victora, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Brampton, Ontario, Canada

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Corunna, Ontario, Canada

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London, Ontario, Canada

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London, Ontario, Canada

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Newmarket, Ontario, Canada

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Oakville, Ontario, Canada

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Peterborough, Ontario, Canada

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Sarnia, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Woodstock, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Québec, Quebec, Canada

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Saint-Jean-sur-Richelieu, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Westmount, Quebec, Canada

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Westmout, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Countries

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United States Canada

References

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Silverman SL, Siris E, Kendler DL, Belazi D, Brown JP, Gold DT, Lewiecki EM, Papaioannou A, Simonelli C, Ferreira I, Balasubramanian A, Dakin P, Ho P, Siddhanti S, Stolshek B, Recknor C. Persistence at 12 months with denosumab in postmenopausal women with osteoporosis: interim results from a prospective observational study. Osteoporos Int. 2015 Jan;26(1):361-72. doi: 10.1007/s00198-014-2871-6. Epub 2014 Sep 19.

Reference Type BACKGROUND
PMID: 25236877 (View on PubMed)

Silverman SL, Siris E, Belazi D, Recknor C, Papaioannou A, Brown JP, Gold DT, Lewiecki EM, Quinn G, Balasubramanian A, Yue S, Stolshek B, Kendler DL. Persistence at 24 months with denosumab among postmenopausal women with osteoporosis: results of a prospective cohort study. Arch Osteoporos. 2018 Aug 7;13(1):85. doi: 10.1007/s11657-018-0491-z.

Reference Type BACKGROUND
PMID: 30088189 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20101218

Identifier Type: -

Identifier Source: org_study_id

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