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Study Complete
Sponsor ID
20110126

Observational study of Denosumab (Prolia®) in Postmenopausal Women with Osteoporosis

Sponsor ID
20110126
Clinicaltrials.gov ID
NCT01668589
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
N/A
Product
denosumab
Type
Observational
Masking
N/A
Enrollment
1501
Additional Study Details

Protocol Summary

Primary Outcome Measures

Medication taking-behavior

Timeframe: 12 and 24 months

Secondary Outcome Measures
Not Available

Locations

Location
Status
Contact Us
Location
Research Site
Bammental, Germany, 69245
Status
Recruiting
Location
Research Site
Athens, Greece, 16674
Status
Recruiting
Location
Research Site
Bad Reichenhall, Germany, 83453
Status
Recruiting
Location
Research Site
Bautzen, Germany, 02625
Status
Recruiting
Location
Research Site
Chania, Crete, Greece, 73136
Status
Recruiting
Location
Research Site
Hannover, Germany, 30459
Status
Recruiting
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Study Info
Age
N/A
Condition
  • Osteoporosis
    • Sex
    Assigned Female at Birth
    Trial Dates
    Nov 2011 - Aug 2015
    Inclusion and Exclusion 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.