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Transition From Alendronate to Romosozumab (AMG 785)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01588509
First Posted: May 1, 2012
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
  Purpose
The purpose of this study is to estimate the percent change from baseline in lumbar spine bone mineral density (BMD) following multiple-dose administrations of romosozumab in postmenopausal women with low BMD previously treated with alendronate.

Condition Intervention Phase
Osteoporosis Drug: Romosozumab Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized Study to Estimate the Percent Change From Baseline in Lumbar Spine Bone Mineral Density After 3 Months of AMG 785 Administration in Postmenopausal Women With Low Bone Mineral Density Previously Treated With Alendronate

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Change in lumbar spine bone mineral density (BMD) [ Time Frame: Change from baseline at day 85 ]

Secondary Outcome Measures:
  • Change in total hip and femoral neck BMD [ Time Frame: Change from baseline at day 85 ]
  • Change in serum type 1 aminoterminal propeptide (P1NP) measurements [ Time Frame: Change from baseline at day 85 ]
  • Number of treatment-emergent adverse events to include clinically significant changes in chemistry, hematology, physical examinations, electrocardiograms, and incidences of subjects who develop anti-AMG 785 antibodies [ Time Frame: Up to day 85 ]
  • Mean (SD) serum concentration of AMG 785 [ Time Frame: Baseline through day 85 ]
  • Change in serum C-telopeptide (sCTX) measurements [ Time Frame: Change from baseline at day 85 ]

Enrollment: 60
Actual Study Start Date: March 30, 2012
Study Completion Date: November 21, 2012
Primary Completion Date: November 21, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Romosozumab 140 mg
Participants received romosozumab 140 mg administered subcutaneously once a month for 3 months.
Drug: Romosozumab
Administered by subcutaneous injection
Other Names:
  • AMG 785
  • EVENITY™
Experimental: Romosozumab 210 mg
Participants received romosozumab 210 mg administered subcutaneously once a month for 3 months.
Drug: Romosozumab
Administered by subcutaneous injection
Other Names:
  • AMG 785
  • EVENITY™

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal women, defined as no vaginal bleeding or spotting for ≥ 12 months
  • Low bone mineral density at screening [defined by a bone mineral density (BMD) T-score ≤ -2.0 and ≥ -4.0 at the lumbar spine (L1 to L4; or BMD T-score of evaluable vertebrae), total hip, or femoral neck]
  • Currently taking alendronate (70 mg weekly or equivalent) exclusively for ≥ 1 year with verbal agreement that the subject has taken ≥ 80% of their doses with good tolerance

Exclusion Criteria:

  • History of vertebral fracture, or fragility fracture of the wrist, humerus, hip or pelvis after age 50; or recent bone fracture within 6 months prior to screening
  • History of metabolic or bone disease such as Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome
  • Vitamin D deficiency (defined as 25-OH-VitD levels < 20 ng/mL)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588509


Locations
United States, Arizona
Research Site
Tucson, Arizona, United States, 85711
United States, California
Research Site
Walnut Creek, California, United States, 94598
United States, Georgia
Research Site
Gainesville, Georgia, United States, 30501
United States, Hawaii
Research Site
Honolulu, Hawaii, United States, 96813
United States, Maryland
Research Site
Bethesda, Maryland, United States, 20817
United States, New Mexico
Research Site
Albuquerque, New Mexico, United States, 87106
United States, New York
Research Site
West Haverstraw, New York, United States, 10993
United States, Pennsylvania
Research Site
Wyomissing, Pennsylvania, United States, 19610
United States, Washington
Research Site
Seattle, Washington, United States, 98144
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01588509     History of Changes
Other Study ID Numbers: 20110253
First Submitted: April 17, 2012
First Posted: May 1, 2012
Last Update Posted: June 5, 2017
Last Verified: May 2017

Keywords provided by Amgen:
AMG 785, bone mineral density, alendronate

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs