Trial record 20 of 971 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
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: 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 August 28, 2014