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

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ClinicalTrials.gov Identifier: NCT02732210
Recruitment Status : Completed
First Posted : April 8, 2016
Results First Posted : December 14, 2016
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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.

Condition or disease
Osteoporosis, Age-Related

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 Design
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Study Type : Observational
Actual Enrollment : 935 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study to Evaluate Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis in Routine Clinical Practice
Actual Study Start Date : July 6, 2011
Actual Primary Completion Date : April 7, 2014
Actual Study Completion Date : April 14, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Postmenoapusal women with osteoporsis. Sampling method is Invitation to Volunteer.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02732210


Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

Publications:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02732210    
Other Study ID Numbers: 20101218
First Posted: April 8, 2016    Key Record Dates
Results First Posted: December 14, 2016
Last Update Posted: February 20, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases