Observational Study of Prolia® in Postmenopausal Women With Osteoporosis
This study is currently recruiting participants.
Verified April 2013 by Amgen
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01668589
First received: August 16, 2012
Last updated: April 23, 2013
Last verified: April 2013
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Purpose
The study is being performed to describe Prolia® patients' medication-taking behavior in a non-interventional routine clinical care setting
| 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 and Greece |
Resource links provided by NLM:
MedlinePlus related topics:
Osteoporosis
Drug Information available for:
Denosumab
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- Medication taking-behavior [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of adverse drug reactions and serious adverse drug reactions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1200 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
Eligibility| 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 OP in postmenopausal women at increased risk of fractures according to the approved Regional Prescribing Information (e.g. EU SmPC in Germany, Austria and Greece)
- Enrolled into the study within 4 weeks of receiving their first injection of denosumab (Prolia®) according to the approved Regional Prescribing Information (e.g. EU SmPC in Germany, Austria and Greece)
- Appropriate written informed consent has been obtained (as required per local country regulations).
Exclusion Criteria:
- Subject is currently enrolled in or has not yet completed at least 6 months since ending any investigational procedure, device or drug trial(s), or subject is receiving any investigational agent(s)
- Contra-indicated for treatment with Prolia® according to the approved Regional Prescribing Information (e.g. EU SmPC in Germany, Austria and Greece)
- Participation in ongoing or previous denosumab clinical trials
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668589
Show 140 Study Locations
Contacts
| Contact: Amgen Call Center | 866-572-6436 |
Show 140 Study LocationsSponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01668589 History of Changes |
| Other Study ID Numbers: | 20110126 |
| Study First Received: | August 16, 2012 |
| Last Updated: | April 23, 2013 |
| Health Authority: | Greece: Ethics Committee Austria: Ethikkommission Germany: Paul-Ehrlich-Institut |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013