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

Osteoporosis, Age-Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732210
• Other study ID #: 20101218
• Status: Completed
• Start date: July 6, 2011
• Est. completion date: April 14, 2014

Study information

• Verified date: November 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 935
• Est. completion date: April 14, 2014
• Est. primary completion date: April 7, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Age-Related

Locations

Country	Name	City	State
Canada	Research Site	Brampton	Ontario
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Corunna	Ontario
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	London	Ontario
Canada	Research Site	London	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	Oakville	Ontario
Canada	Research Site	Peterborough	Ontario
Canada	Research Site	Pointe-Claire	Quebec
Canada	Research Site	Pointe-Claire	Quebec
Canada	Research Site	Quebec
Canada	Research Site	Sarnia	Ontario
Canada	Research Site	Saskatoon	Saskatchewan
Canada	Research Site	St. Jean-Sur-Richelieu	Quebec
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Trois-Rivieres	Quebec
Canada	Research Site	Vancouver	British Columbia
Canada	Research Site	Victora	British Columbia
Canada	Research Site	Westmount	Quebec
Canada	Research Site	Westmout	Quebec
Canada	Research Site	Winnipeg	Manitoba
Canada	Research Site	Winnipeg	Manitoba
Canada	Research Site	Woodstock	Ontario
United States	Research Site	Akron	Ohio
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Alton	Illinois
United States	Research Site	Asheboro	North Carolina
United States	Research Site	Atlanta	Georgia
United States	Research Site	Austin	Texas
United States	Research Site	Bend	Oregon
United States	Research Site	Bettendorf	Iowa
United States	Research Site	Birmingham	Alabama
United States	Research Site	Brooklyn	New York
United States	Research Site	Butler	New Jersey
United States	Research Site	Centerville	Ohio
United States	Research Site	Chandler	Arizona
United States	Research Site	Charleston	West Virginia
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chesapeake	Virginia
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Detroit	Michigan
United States	Research Site	Dover	New Jersey
United States	Research Site	Duncansville	Pennsylvania
United States	Research Site	East Lansing	Michigan
United States	Research Site	Fort Myers	Florida
United States	Research Site	Gainesville	Georgia
United States	Research Site	Glendale	Wisconsin
United States	Research Site	Hemet	California
United States	Research Site	Hollywood	Florida
United States	Research Site	Jackson	Tennessee
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kissimmee	Florida
United States	Research Site	Laguna Hills	California
United States	Research Site	Lakewood	Colorado
United States	Research Site	Lansdale	Pennsylvania
United States	Research Site	Lansing	Michigan
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Los Angeles	California
United States	Research Site	Madison	Wisconsin
United States	Research Site	Middletown	Ohio
United States	Research Site	Midlothian	Virginia
United States	Research Site	Murrieta	California
United States	Research Site	Myrtle Beach	South Carolina
United States	Research Site	Oxnard	California
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Peoria	Arizona
United States	Research Site	Phoenix	Arizona
United States	Research Site	Plainview	New York
United States	Research Site	Rockford	Illinois
United States	Research Site	Santa Maria	California
United States	Research Site	Santa Monica	California
United States	Research Site	Sebring	Florida
United States	Research Site	South Lake Tahoe	California
United States	Research Site	Southlake	Texas
United States	Research Site	Spokane	Washington
United States	Research Site	Springfield	Missouri
United States	Research Site	Tabor City	North Carolina
United States	Research Site	Trumbull	Connecticut
United States	Research Site	Victorville	California
United States	Research Site	Winchester	Virginia
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Woodbury	Minnesota
United States	Research Site	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Time to Non-persistence	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
Secondary	Number of Prolia® Injections Received	The number of injections that a participant received over 24 months (including the baseline injection) regardless of when the injection was received.	24 months
Secondary	Percentage of Participants Satisfying Medication-taking Behavior at 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
Secondary	Percentage of Participants Satisfying Medication-taking Behavior at 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

External Links

•   AmgenTrials clinical trials website