Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis
This study is ongoing, but not recruiting participants.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00523341
First received: August 30, 2007
Last updated: January 20, 2011
Last verified: January 2011
| Tracking Information | |||||
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| First Received Date ICMJE | August 30, 2007 | ||||
| Last Updated Date | January 20, 2011 | ||||
| Start Date ICMJE | August 2007 | ||||
| Estimated Primary Completion Date | June 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To describe the safety and tolerability of up to 7 years denosumab administration as measured by adverse event monitoring, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab [ Time Frame: 7 years ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
To describe the safety and tolerability of up to 5 years denosumab administration as measured by adverse event monitoring, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab | ||||
| Change History | Complete list of historical versions of study NCT00523341 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis | ||||
| Official Title ICMJE | An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis | ||||
| Brief Summary | This is a 7 year multi-national, multi-center, open-label, single-arm extension study enrolling subjects who have completed the 3 year pivotal study. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: denosumab
1cc SC injection - 60mg every 6 months
Other Name: AMG 162 |
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| Study Arm (s) | Experimental: open label
Open label dosing. All subjects receive active drug.
Intervention: Drug: denosumab |
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| Publications * | Papapoulos S, Chapurlat R, Libanati C, Brandi ML, Brown JP, Czerwiński E, Krieg MA, Man Z, Mellström D, Radominski SC, Reginster JY, Resch H, Román Ivorra JA, Roux C, Vittinghoff E, Austin M, Daizadeh N, Bradley MN, Grauer A, Cummings SR, Bone HG. Five years of denosumab exposure in women with postmenopausal osteoporosis: results from the first two years of the FREEDOM extension. J Bone Miner Res. 2012 Mar;27(3):694-701. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 5600 | ||||
| Estimated Completion Date | August 2015 | ||||
| Estimated Primary Completion Date | June 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Subjects must have completed the 3 year pivotal study. |
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| Gender | Female | ||||
| Ages | 60 Years to 94 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00523341 | ||||
| Other Study ID Numbers ICMJE | 20060289 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Global Development Leader, Amgen Inc. | ||||
| Study Sponsor ICMJE | Amgen | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Amgen | ||||
| Verification Date | January 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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