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History of Changes for Study: NCT01575834
Registrational Study With AMG 785 to Treat Postmenopausal Osteoporosis
Latest version (submitted December 1, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 10, 2012 None (earliest Version on record)
2 April 30, 2012 Contacts/Locations and Study Status
3 May 9, 2012 Study Status and Contacts/Locations
4 May 17, 2012 Contacts/Locations and Study Status
5 May 24, 2012 Contacts/Locations and Study Status
6 May 31, 2012 Contacts/Locations, Sponsor/Collaborators and Study Status
7 June 8, 2012 Sponsor/Collaborators, Study Status and Contacts/Locations
8 June 14, 2012 Contacts/Locations and Study Status
9 July 12, 2012 Sponsor/Collaborators, Study Status and Contacts/Locations
10 August 7, 2012 Contacts/Locations and Study Status
11 August 10, 2012 Contacts/Locations and Study Status
12 September 26, 2012 Contacts/Locations, Study Status, Outcome Measures, Study Design and Study Identification
13 October 10, 2012 Contacts/Locations and Study Status
14 November 13, 2012 Contacts/Locations and Study Status
15 November 28, 2012 Contacts/Locations and Study Status
16 December 5, 2012 Study Status
17 January 9, 2013 Contacts/Locations and Study Status
18 January 17, 2013 Contacts/Locations and Study Status
19 February 26, 2013 Contacts/Locations and Study Status
20 March 6, 2013 Study Status and Contacts/Locations
21 March 14, 2013 Contacts/Locations and Study Status
22 March 27, 2013 Contacts/Locations and Study Status
23 April 4, 2013 Study Status and Contacts/Locations
24 June 13, 2013 Study Status and Contacts/Locations
25 August 6, 2013 Study Status, Contacts/Locations and Eligibility
26 March 3, 2014 Recruitment Status, Contacts/Locations, Study Status, Arms and Interventions, Study Design and Eligibility
27 February 19, 2016 Study Status
28 March 7, 2016 Study Status
29 April 22, 2016 Arms and Interventions and Study Status
30 June 6, 2016 Arms and Interventions and Study Status
31 July 29, 2016 Study Status and Eligibility
32 January 8, 2017 Recruitment Status and Study Status
33 May 9, 2017 Arms and Interventions, Study Status, Contacts/Locations, Study Identification, References, Eligibility and Study Description
34 August 1, 2018 Study Status and References
35 September 6, 2018 Study Status
Show
Results Submission Events
36 October 11, 2018 Outcome Measures, Study Status, More Information, Adverse Events, Baseline Characteristics and Participant Flow
37 February 1, 2019 Contacts/Locations, Study Status and References
38 August 9, 2019 Study Status and References
39 April 6, 2020 Study Status and References
40 May 4, 2020 Study Status and References
41 December 1, 2020 Study Status and References
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Study NCT01575834
Submitted Date:  April 10, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: 20070337
Brief Title: Registrational Study With AMG 785 to Treat Postmenopausal Osteoporosis
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
Secondary IDs: 2011-001456-11 [EudraCT Number]
Open or close this module Study Status
Record Verification: April 2012
Overall Status: Recruiting
Study Start: March 2012
Primary Completion: March 2015 [Anticipated]
Study Completion: May 2015 [Anticipated]
First Submitted: April 4, 2012
First Submitted that
Met QC Criteria:
April 10, 2012
First Posted: April 12, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 10, 2012
Last Update Posted: April 12, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Amgen
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis
Detailed Description:
Open or close this module Conditions
Conditions: Postmenopausal Osteoporosis
Keywords: Osteoporosis, Osteoporosis-Postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 5600 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Active Treatment
sub-cutaneous AMG 785 injections for 12 months, followed by sub-cutaneous open-label denosumab injections for another 12 months
Drug: AMG 785
sub-cutaneous AMG 785 injections for 12 months, followed by sub-cutaneous open-label denosumab injections for another 12 months
Placebo Comparator: Placebo
sub-cutaneous placebo injections for 12 months, followed by sub-cutaneous open-label denosumab injections for another 12 months
Drug: Placebo
sub-cutaneous placebo injections for 12 months, followed by sub-cutaneous open-label denosumab injections for another 12 months
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of vertebral fracture
[ Time Frame: 12 Months ]

Secondary Outcome Measures:
1. Incidence of Fracture
[ Time Frame: 12 Months ]

2. Changes In Bone Mineral Density from Baseline to 12 Months
[ Time Frame: 12 Months ]

3. Incidence of Fracture
[ Time Frame: 24 Months ]

4. Changes In Bone Mineral Density from Baseline to 24 Months
[ Time Frame: 24 Months ]

Open or close this module Eligibility
Minimum Age: 60 Years
Maximum Age: 90 Years
Sex: Female
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Amgen Call Center
Telephone: 866-572-6436
Study Officials: MD
Study Director
Amgen
Locations: United States, Arizona
Research Site
[Recruiting]
Tucson, Arizona, United States, 85704
United States, California
Research Site
[Recruiting]
Laguna Hills, California, United States, 92653
United States, Colorado
Research Site
[Recruiting]
Lakewood, Colorado, United States, 80227
United States, Georgia
Research Site
[Recruiting]
Gainesville, Georgia, United States, 30501
United States, Maryland
Research Site
[Recruiting]
Bethesda, Maryland, United States, 20817
United States, Michigan
Research Site
[Recruiting]
Detroit, Michigan, United States, 48236
United States, North Dakota
Research Site
[Recruiting]
Fargo, North Dakota, United States, 58104
United States, Pennsylvania
Research Site
[Recruiting]
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Research Site
[Recruiting]
Denton, Texas, United States, 76210-8625
Canada
Research Site
[Recruiting]
Quebec, Canada, G1V 3M7
Canada, British Columbia
Research Site
[Recruiting]
Vancouver, British Columbia, Canada, V5Z 4E1
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: AmgenTrials clinical trials website
Available IPD/Information:

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