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Study Complete
Sponsor ID
20101218

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

Sponsor ID
20101218
Clinicaltrials.gov ID
NCT02732210
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 4
Product
denosumab
Type
Observational
Masking
N/A
Enrollment
935
Additional Study Details

Protocol Summary

Primary Outcome Measures

Persistence (yes/no) with Prolia® at 12 months

Timeframe: 12 month

Persistence (yes/no) with Prolia® at 24 months

Timeframe: 24 months

Time to non-persistence

Timeframe: Time of persistence plus 6 months

Number of injections received within the allowable window over 24 months

Timeframe: 24 months

Incidence of subject satisfying medication-taking behavior (yes/no) at 12 months

Timeframe: 12 months

Incidence of subject satisfying medication-taking behavior (yes/no) at 24 months

Timeframe: 24 months

Secondary Outcome Measures
Not Available

Locations

Location
Status
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Location
Research Site
Akron, OH, United States, 44313
Status
Recruiting
Location
Research Site
Albuquerque, NM, United States, 87106
Status
Recruiting
Location
Research Site
Asheboro, NC, United States, 27203
Status
Recruiting
Location
Research Site
Atlanta, GA, United States, 30342
Status
Recruiting
Location
Research Site
Austin, TX, United States, 78731
Status
Recruiting
Location
Research Site
Bend, OR, United States, 97701
Status
Recruiting
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Study Info
Age
N/A
Condition
  • Osteoporosis
    • Sex
    Assigned Female at Birth
    Trial Dates
    Jul 2011 - Apr 2014
    Inclusion and Exclusion Criteria
    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.