Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00523341

Purpose

This is a 2 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 III

MedlinePlus related topics: Osteoporosis

Drug Information available for: Denosumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Amgen:

Primary Outcome Measures:

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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

• To describe the effect of denosumab administration on changes in BMD [ Time Frame: 2 years ] [ Designated as safety issue: No ]
• To describe the incidence of fractures [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
• To describe the effect of denosumab administration on markers of bone turnover [ Time Frame: 2 years ] [ Designated as safety issue: No ]
• To describe the change in safety labs [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
• To describe the effect of up to 5 years denosumab administration on bone histology in subjects who previously received denosumab [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	5600
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
open label: Experimental Open label dosing. All subjects receive active drug.	Drug: denosumab 1cc SC injection - 60mg every 6 months

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523341

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20060289
Study First Received:	August 30, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00523341 History of Changes
Health Authority:	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 - French Health Products Safety Agency; Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe; Greece: National Organization for Medicines; Hungary: National Institute of Pharmacy; Italy: Local Ethics Committees; 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; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Romaina: National Medicines Agency; Romania: Romanian National Drug Agency; Serbia: Medicine and Medical Devices Agency of Serbia; Slovakia: State Institiute for Drug Control; 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; Argentina: ANMAT (Administracion Nacional de Medicamentos Alimentos y Tecnologia Medica); 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

Keywords provided by Amgen:

postmenopausal osteoporosis
low bone density
fractures
low bone mass

Study placed in the following topic categories:

Musculoskeletal Diseases
Fractures, Bone
Osteoporosis, Postmenopausal

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoporosis, Postmenopausal
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on May 07, 2009