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Study Complete
Sponsor ID
20110253

Transition from Alendronate to Romosozumab (AMG 785)

Sponsor ID
20110253
Clinicaltrials.gov ID
NCT01588509
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1
Product
AMG 785
Type
Interventional
Masking
None (Open Label)
Enrollment
60
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change in lumbar spine bone mineral density (BMD)

Timeframe: Change from baseline at day 85

Secondary Outcome Measures

Change in total hip and femoral neck BMD

Timeframe: Change from baseline at day 85

Change in serum type 1 aminoterminal propeptide (P1NP) measurements

Timeframe: 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

Timeframe: Up to day 85

Mean (SD) serum concentration of AMG 785

Timeframe: Baseline through day 85

Change in serum C-telopeptide (sCTX) measurements

Timeframe: Change from baseline at day 85

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Tucson, AZ, United States, 85711
Status
Completed
Location
Research Site
Bethesda, MD, United States, 20817
Status
Recruiting
Location
Research Site
Walnut Creek, CA, United States, 94598
Status
Recruiting
Location
Research Site
Honolulu, HI, United States, 96813
Status
Recruiting
Location
Research Site
Albuquerque, NM, United States, 87106
Status
Recruiting
Location
Research Site
West Haverstraw, NY, United States, 10993
Status
Recruiting
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Study Info
Age
55 - 85 Years
Condition
  • Osteoporosis
    • Sex
    Assigned Female at Birth
    Trial Dates
    Mar 2012 - Nov 2012
    Inclusion and Exclusion 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)