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 (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00523341
First received: August 30, 2007
Last updated: July 31, 2014
Last verified: July 2014
  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: 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 ]

Enrollment: 4550
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

Postmenopausal women who have attended the 20030216 study month 36 visit will be eligible to participate if they meet the inclusion and exclusion criteria given below.

Inclusion Criteria

  • Subjects must sign the informed consent before any study specific procedures are performed and agree to receive denosumab 60 mg SC injection every 6 months
  • Subjects must not have discontinued investigational product during the 20030216 study and must have attended the 20030216 study month 36 visit
  • Subjects must be re-consented prior to (or at) the 24 month visit for participation beyond month 24.

Exclusion Criteria

  • Permanently non-ambulatory subjects (use of an assistive device eg, cane, walker, etc. is permitted)
  • Missed 2 or more investigational product doses during the 20030216 study
  • Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
  • Developed sensitivity to mammalian cell derived drug products during the 20030216 study
  • Unable to tolerate calcium supplementation during the last 6 months of participation in the 20030216 study (between the month 30 and month 36 20030216 study visits)
  • Currently receiving any investigational product other than denosumab or having received any investigational product during the 20030216 study
  • Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium, or tibolone
  • For bone biopsy sub-study subjects only: known or suspected sensitivity or contraindication to tetracycline derivatives
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Amgen
ClinicalTrials.gov Identifier: NCT00523341     History of Changes
Other Study ID Numbers: 20060289
Study First Received: August 30, 2007
Last Updated: July 31, 2014
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:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 30, 2014