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

NCT02732210 | Completed Results

• 1 other identifier: 20101218
• Study Type: observational
• Target: 935
• Locations: 2 countries
• Sites: 89

Brief Summary

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.

Conditions

Osteoporosis, Age-Related

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Persistence With Prolia® at 12 Ponths

  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

  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 Outcomes (4)

• Time to Non-persistence

  24 months

• Number of Prolia® Injections Received

  24 months

• Percentage of Participants Satisfying Medication-taking Behavior at 12 Months

  12 months

• Percentage of Participants Satisfying Medication-taking Behavior at 24 Months

  24 months

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

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (89)

Research Site

Birmingham, Alabama, 35205, United States

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Chandler, Arizona, 85224, United States

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Peoria, Arizona, 85381, United States

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Phoenix, Arizona, 85050, United States

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Hemet, California, 92543, United States

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Laguna Hills, California, 92653, United States

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Los Angeles, California, 90048, United States

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Murrieta, California, 92563, United States

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Oxnard, California, 93030, United States

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Santa Maria, California, 93454, United States

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Santa Monica, California, 90404, United States

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South Lake Tahoe, California, 96150, United States

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Victorville, California, 92395, United States

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Lakewood, Colorado, 80227, United States

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Trumbull, Connecticut, 06611, United States

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Fort Myers, Florida, 33912, United States

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Hollywood, Florida, 33021, United States

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Jacksonville, Florida, 32258, United States

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Kissimmee, Florida, 34741, United States

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Pembroke Pines, Florida, 33028, United States

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Sebring, Florida, 33870, United States

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Atlanta, Georgia, 30342, United States

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Gainesville, Georgia, 30501, United States

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Woodstock, Georgia, 30189, United States

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Alton, Illinois, 62002, United States

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Rockford, Illinois, 61103, United States

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Bettendorf, Iowa, 52722, United States

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Detroit, Michigan, 48236, United States

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East Lansing, Michigan, 48823, United States

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Lansing, Michigan, 48910, United States

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Woodbury, Minnesota, 55125, United States

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Springfield, Missouri, 65807, United States

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Las Vegas, Nevada, 89146, United States

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Butler, New Jersey, 07405, United States

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Dover, New Jersey, 07801, United States

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Albuquerque, New Mexico, 87106, United States

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Brooklyn, New York, 11201, United States

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Plainview, New York, 11803, United States

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Asheboro, North Carolina, 27203, United States

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Charlotte, North Carolina, 28210, United States

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Tabor City, North Carolina, 28463, United States

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Winston-Salem, North Carolina, 27103, United States

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Akron, Ohio, 44313, United States

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Centerville, Ohio, 45459, United States

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Cincinnati, Ohio, 45236, United States

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Middletown, Ohio, 45044, United States

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Bend, Oregon, 97701, United States

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Duncansville, Pennsylvania, 16635, United States

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Lansdale, Pennsylvania, 19446, United States

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Myrtle Beach, South Carolina, 29572, United States

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Jackson, Tennessee, 38305, United States

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Austin, Texas, 78731, United States

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Southlake, Texas, 76092, United States

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Chesapeake, Virginia, 23321, United States

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Midlothian, Virginia, 23114, United States

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Winchester, Virginia, 22601, United States

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Spokane, Washington, 99204, United States

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Charleston, West Virginia, 25304, United States

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Glendale, Wisconsin, 53217, United States

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Madison, Wisconsin, 53705, United States

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Calgary, Alberta, T2X 3X7, Canada

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Vancouver, British Columbia, V5Z 4E1, Canada

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Victora, British Columbia, V9A 7N6, Canada

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Winnipeg, Manitoba, R3A 1M3, Canada

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Winnipeg, Manitoba, R3T 2E8, Canada

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St. John's, Newfoundland and Labrador, A1A 5E8, Canada

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St. John's, Newfoundland and Labrador, A1E 2E2, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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Brampton, Ontario, L6T 0G1, Canada

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Corunna, Ontario, N0N 1G0, Canada

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London, Ontario, N5W 6A2, Canada

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London, Ontario, N6A 5G6, Canada

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Newmarket, Ontario, L3Y 5G8, Canada

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Oakville, Ontario, L6J 1X8, Canada

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Peterborough, Ontario, K9H 2P4, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Toronto, Ontario, M3M 3E5, Canada

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Toronto, Ontario, M4S 1Y2, Canada

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Woodstock, Ontario, N4S 5P5, Canada

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Montreal, Quebec, H2L 1S6, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Pointe-Claire, Quebec, H9R 3J1, Canada

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Pointe-Claire, Quebec, H9R 4S3, Canada

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Québec, Quebec, G1V 3M7, Canada

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Saint-Jean-sur-Richelieu, Quebec, J2W 1J1, Canada

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Trois-Rivières, Quebec, G8Z 1Y2, Canada

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Westmount, Quebec, H3Z 2P9, Canada

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Westmout, Quebec, H3Z 1E5, Canada

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Saskatoon, Saskatchewan, S7K 0H6, Canada

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Related Publications (2)

• 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.

  PMID: 25236877 BACKGROUND

• 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.

  PMID: 30088189 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

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: April 4, 2016
• First Posted: April 8, 2016
• Study Start: July 6, 2011
• Primary Completion: April 7, 2014
• Study Completion: April 14, 2014
• Last Updated: November 29, 2022
• Results First Posted: December 14, 2016

Record last verified: 2022-11

Locations

CA (29); US (60)