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:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00523341
First received: August 30, 2007
Last updated: January 20, 2011
Last verified: January 2011
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00523341

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  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 April 15, 2014