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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteopenia Osteoporosis |
Drug: denosumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- • To describe the effect of denosumab administration on changes in BMD [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- • To describe the incidence of fractures [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
- • To describe the effect of denosumab administration on markers of bone turnover [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- • To describe the change in safety labs [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
- • To describe the effect of up to 7 years denosumab administration on bone histology in subjects who previously received denosumab [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 5600 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: open label
Open label dosing. All subjects receive active drug.
|
Drug: denosumab
1cc SC injection - 60mg every 6 months
Other Name: AMG 162
|
Eligibility| Ages Eligible for Study: | 60 Years to 94 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Subjects must have completed the 3 year pivotal study.
Contacts and Locations More Information
Additional Information:
No publications provided by Amgen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00523341 History of Changes |
| Other Study ID Numbers: | 20060289 |
| Study First Received: | August 30, 2007 |
| Last Updated: | January 20, 2011 |
| Health Authority: | Serbia: Medicine and Medical Devices Agency of Serbia Slovakia: State Institiute for Drug Control Argentina: Ministry of Health Australia: Therapeutic Goods Administration Austria: Bundesamt für Sicherheit im Gesundheitswesen Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement Brazil: ANVISA (Agência Nacional de Vigilância Sanitária) Brazil: Ministry of Health Bulgaria: Bulgarian Drug Agency Canada: Health Canada Czech Republic: State Institute for Drug Control Czech Republic: Statni ustav pro kontrolu leciv Denmark: Laegemiddelstyrelsen Estonia: State Agency of Medicines Finland: Lääkelaitos France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe Greece: National Organization for Medicines Hungary: National Institute of Pharmacy Italy: Local Ethics Committees Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romaina: National Medicines Agency Romania: Romanian National Drug Agency Argentina: ANMAT (Administracion Nacional de Medicamentos Alimentos y Tecnologia Medica) Latvia: State Agency of Medicines Lithuania: State Medicines Control Agency of Lithuania Malta: Medicines Authority Mexico: COFEPRIS Mexico: Ministry of Health Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research Norway: Norwegian Medicines Agency Slovakia: Štátny ústav pre kontrolu lieciv Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Amgen:
|
postmenopausal osteoporosis low bone density fractures low bone mass |
Additional relevant MeSH terms:
|
Bone Diseases, Metabolic Osteoporosis Osteoporosis, Postmenopausal Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on June 17, 2013