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Completed

NCT Number: NCT02732210

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

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.

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Key information

Conditions

Osteoporosis, Age-Related Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 8, 2016
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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