Registrational Study With AMG 785 to Treat Postmenopausal Osteoporosis (FRAME)
This study is ongoing, but not recruiting participants.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01575834
First received: April 4, 2012
Last updated: July 29, 2016
Last verified: July 2016
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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 Drug: Denosumab |
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: | December 2016 |
| Primary Completion Date: | December 2015 (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 first 12 months of the study
Drug: Denosumab
Sub-cutaneous open-label denosumab injections for months 13-24 of the study.
|
|
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 first 12 months of the study.
Drug: Denosumab
Sub-cutaneous open-label denosumab injections for months 13-24 of the study.
|
Eligibility| Ages Eligible for Study: | 55 Years to 90 Years (Adult, Senior) |
| Genders Eligible for Study: | Female |
| 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
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:
| 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: | July 29, 2016 |
| 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 Denosumab Bone Density Conservation Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 30, 2016