Trial record 20 of 943 for:    "Osteoporosis"

Registrational Study With AMG 785 to Treat Postmenopausal Osteoporosis (FRAME)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01575834
First received: April 4, 2012
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis


Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: AMG 785
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of AMG 785 Treatment in Postmenopausal Women With Osteoporosis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Incidence of vertebral fracture [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Incidence of vertebral fracture [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of Fracture [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Changes In Bone Mineral Density from Baseline to 12 Months [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Incidence of Fracture [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Changes In Bone Mineral Density from Baseline to 24 Months [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Enrollment: 7180
Study Start Date: March 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Treatment
sub-cutaneous AMG 785 injections for 12 months, followed by sub-cutaneous open-label denosumab injections for another 24 months
Drug: AMG 785
sub-cutaneous AMG 785 injections for 12 months, followed by sub-cutaneous open-label denosumab injections for another 24 months
Placebo Comparator: Placebo
sub-cutaneous placebo injections for 12 months, followed by sub-cutaneous open-label denosumab injections for another 24 months
Drug: Placebo
sub-cutaneous placebo injections for 12 months, followed by sub-cutaneous open-label denosumab injections for another 24 months

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Postmenopausal women osteoporosis, defined as low bone mineral density

Exclusion Criteria:

  • Severe osteoporosis
  • Use of agents affecting bone metabolism
  • History of metabolic or bone disease (except osteoporosis)
  • Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
  • Current hyper- or hypocalcemia
  • Current, uncontrolled hyper- or hypothyroidism
  • Current, uncontrolled hyper- or hypoparathyroidism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575834

  Show 243 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01575834     History of Changes
Other Study ID Numbers: 20070337, 2011-001456-11
Study First Received: April 4, 2012
Last Updated: March 3, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Brazil: Ministry of Health
Mexico: Ministry of Health
India: Ministry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Japan: Pharmaceuticals and Medical Devices Agency
European Union: European Medicines Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe
Mexico: Federal Commission for Protection Against Health Risks
Peru: Instituto Nacional de Salud
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Denmark: National Board of Health
Estonia: The State Agency of Medicine
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Spain: Agencia Espa?ola de Medicamentos y Productos Sanitarios
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
India: Drugs Controller General of India

Keywords provided by Amgen:
Osteoporosis, Osteoporosis-Postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 17, 2014