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Observational Study of Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01668589
First received: August 16, 2012
Last updated: October 7, 2016
Last verified: October 2016
  Purpose
The main objective of this observational study was to describe medication-taking behavior of patients treated with denosumab for postmenopausal osteoporosis (PMO) at 12 and 24 months.

Condition
Postmenopausal Osteoporosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study to Evaluate Medication-taking Behavior With Denosumab (Prolia) and Patient Characteristics in Postmenopausal Women With Osteoporosis in Routine Clinical Practice in Germany, Austria, Greece and Belgium

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Percentage of Participants Persistent With Denosumab Injections at 12 Months and 24 Months [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]

    A participant was considered persistent with denosumab at 12 months if they received at least 1 denosumab injection following the pre-enrolment denosumab injection no later than 6 months + 8 weeks (ie, no greater than 239 days apart).

    A participant was considered persistent with denosumab at 24 months if they received at least 3 denosumab injections following the pre-enrolment denosumab injection, and the length of time between any 2 consecutive denosumab injections did not exceed 6 months + 8 weeks (ie, no greater than 239 days apart).


  • Percentage of Participants Adherent to Denosumab Injection at 12 Months and 24 Months [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]

    A participant was considered adherent to denosumab at 12 months if they received at least 1 denosumab injection over the 12-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart).

    A participant was considered adherent to denosumab at 24 months if they received at least 3 denosumab injections over the 24-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart).


  • Medication Coverage Ratio (MCR) for Denosumab Injection at 12 Months and 24 Months [ Time Frame: From baseline to 12 months and 24 months ] [ Designated as safety issue: No ]

    MCR at 12 months was defined as the accumulative number of days covered with denosumab treatment during the first 12 months divided by 366 days, expressed as a percentage.

    MCR at 24 months was defined as the accumulative number of days covered with denosumab treatment during the first 24 months divided by 732 days, expressed as a percentage.

    It was assumed that each injection of denosumab treatment provided 6 months of coverage (or 183 days) from the date of injection or until the date of the next injection, whichever comes first. So, a participant who received only 1 injection in the first year would have MCR at 12 months equal to 50%.



Secondary Outcome Measures:
  • Time to Non-persistence With Denosumab Injection [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Time to non-persistence for non-persistent patients was calculated as the time between the date of the first denosumab injection and the date of last denosumab injection received during the period where the patient was still classified as persistent, plus 6 months (183 days). Participants were considered persistent at 24 months if they received at least 4 injections, including the baseline injection, with no more than 6 months + 8 weeks apart between any 2 consecutive injections.

  • Percentage of Participants Who Received Denosumab Injections Within the Specified Window [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The percentage of participants who received 0, 1, 2, or 3 denosumab injections within the specified window (defined by the persistence definition as 6 months + 8 weeks). The number of injections that a participant took during the 2-year period after the first pre-enrolment injection, and that were given within the appropriate window from the previous injection, irrespective of when the previous injection was given. Only the first 3 post-baseline injections are considered.

  • Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at 24 Months [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]
    Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).

  • Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 24 Months [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]
    Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).

  • Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 24 Months [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]
    Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).


Enrollment: 1501
Study Start Date: November 2011
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Detailed Description:
The decision to treat patients with denosumab was made independent of and before their enrolment in the study. No study drug was administered as part of the study.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Postmenopausal women indicated for treatment of osteoporosis at increased risk of fractures according to the approval regional prescribing information, e.g. EU SmPC
Criteria

Inclusion Criteria:

  • Indicated for treatment of osteoporosis in postmenopausal women at increased risk of fractures according to the approved Regional Prescribing Information (eg, EU SmPC in Germany, Austria, Greece and Belgium).
  • Enrolled into the study within 4 weeks of receiving their first injection of Prolia® according to the approved Regional Prescribing Information (eg, EU SmPC in Germany, Austria, Greece and Belgium).
  • Appropriate written informed consent has been obtained (as required per local country regulations).

Exclusion Criteria:

  • Patient is currently enrolled in or has been enrolled within the prior 6 months in a study involving any investigational procedure, device or drug.
  • Contraindicated for treatment with Prolia® according to the approved Regional Prescribing Information (eg, EU SmPC in Germany, Austria, Greece and Belgium).
  • Participation in ongoing or previous denosumab clinical trials.
  • Patient has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the patient to give written informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668589

  Show 144 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01668589     History of Changes
Other Study ID Numbers: 20110126 
Study First Received: August 16, 2012
Results First Received: August 1, 2016
Last Updated: October 7, 2016
Health Authority: Greece: Ethics Committee
Austria: Ethikkommission
Germany: Paul-Ehrlich-Institut
Belgium: Ethics Committee

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016