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Transition From Alendronate to AMG 785

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01588509
First received: April 17, 2012
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

This is a phase 1, randomized, open-label, parallel group study conducted in healthy postmenopausal women with low bone mineral density previously treated with alendronate.


Condition Intervention Phase
OSTEOPOROSIS, POSTMENOPAUSAL
Drug: AMG 785 Dose 1
Drug: AMG 785 Dose 2
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in total hip and femoral neck BMD [ Time Frame: Change from baseline at day 85 ] [ Designated as safety issue: No ]
  • Change in serum type 1 aminoterminal propeptide (P1NP) measurements [ Time Frame: Change from baseline at day 85 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Mean (SD) serum concentration of AMG 785 [ Time Frame: Baseline through day 85 ] [ Designated as safety issue: No ]
  • Change in serum C-telopeptide (sCTX) measurements [ Time Frame: Change from baseline at day 85 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: March 2012
Study Completion Date: January 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AMG 785 Treatment A
30 subjects will receive 3 doses
Drug: AMG 785 Dose 1
3 doses
Active Comparator: AMG 785 Treatment B
30 subjects will receive 3 doses
Drug: AMG 785 Dose 2
3 doses

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders 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
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: 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:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01588509     History of Changes
Other Study ID Numbers: 20110253
Study First Received: April 17, 2012
Last Updated: October 10, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 24, 2014