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Completed

NCT Number: NCT01668589

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

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.

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Graz, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Percentage of Participants Persistent With Denosumab Injections at 12 Months and 24 Months

    Time frame: 12 months and 24 months

    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).

  2. Percentage of Participants Adherent to Denosumab Injection at 12 Months and 24 Months

    Time frame: 12 months and 24 months

    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).

  3. Medication Coverage Ratio (MCR) for Denosumab Injection at 12 Months and 24 Months

    Time frame: From baseline to 12 months and 24 months

    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 outcomes

  1. Time to Non-persistence With Denosumab Injection

    Time frame: 24 months

    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.

  2. Percentage of Participants Who Received Denosumab Injections Within the Specified Window

    Time frame: 24 months

    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.

  3. Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at 24 Months

    Time frame: Baseline and Month 24

    Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).

  4. Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 24 Months

    Time frame: Baseline and Month 24

    Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).

  5. Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 24 Months

    Time frame: Baseline and Month 24

    Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 20, 2012
Registry last updated
Jan 30, 2018

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

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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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