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Transition From Alendronate to Romosozumab (AMG 785)

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ClinicalTrials.gov Identifier: NCT01588509
Recruitment Status : Completed
First Posted : May 1, 2012
Results First Posted : March 4, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoporosis Drug: Romosozumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Actual Study Start Date : March 30, 2012
Actual Primary Completion Date : November 21, 2012
Actual Study Completion Date : November 21, 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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™




Primary Outcome Measures :
  1. Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine [ Time Frame: Baseline and day 85 ]
    Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans of the lumbar spine (L1-L4) and analyzed by a central imaging lab.


Secondary Outcome Measures :
  1. Percent Change From Baseline in Bone Mineral Density (BMD) at the Femoral Neck [ Time Frame: Baseline and day 85 ]
    Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab.

  2. Percent Change From Baseline in Bone Mineral Density (BMD) at the Total Hip [ Time Frame: Baseline and day 85 ]
    Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab.

  3. Percent Change From Baseline in Serum Type-1 Aminoterminal Propeptide (P1NP) [ Time Frame: Baseline and days 4, 15, 29, 43, 57, 71, and 85 ]
  4. Percent Change From Baseline in Serum C-telopeptide (sCTX) [ Time Frame: Baseline and days 4, 15, 29, 43, 57, 71, and 85 ]
  5. Number of Participants With Adverse Events [ Time Frame: From first dose of study drug up to day 85 ]

    An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant.

    Laboratory value changes that required treatment or adjustment in current therapy were considered adverse events.

    A treatment-related adverse event (TRAE) was an adverse event assessed by the investigator as possibly related to the investigational product, indicated by a "yes" response to the question: Is there a reasonable possibility that the event may have been caused by the investigational product?

    A serious adverse event was defined as an adverse event that met at least 1 of the following serious criteria:

    • fatal,
    • life-threatening,
    • required in-patient hospitalization or prolongation of existing hospitalization,
    • resulted in persistent or significant disability/incapacity,
    • congenital anomaly/birth defect, and/or
    • other medically important serious event.

  6. Number of Participants Who Developed Anti-romosozumab Antibodies [ Time Frame: Baseline and days 29, 57, and 85 ]
    Two validated assays were used to detect the presence of anti-romosozumab antibodies. An electrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding romosozumab. Samples testing positive in the immunoassay were further tested in a competitive binding bioassay for neutralizing activity against romosozumab. If a sample was positive for binding antibodies and demonstrated neutralizing activity, the participant was defined as positive for neutralizing antibodies. Participants who developed anti-romosozumab antibodies were those with a negative result at baseline and a positive result at any time postbaseline.

  7. Mean Serum Concentration of Romosozumab [ Time Frame: Days 4, 15, 29, 43, 57, 71 and 85 ]


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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
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)

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
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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
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01588509     History of Changes
Other Study ID Numbers: 20110253
First Posted: May 1, 2012    Key Record Dates
Results First Posted: March 4, 2019
Last Update Posted: March 26, 2019
Last Verified: March 2019

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

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