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Transition From Alendronate to Romosozumab (AMG 785)

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Romosozumab
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring AMG 785, bone mineral density, alendronate

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Romosozumab 140 mg

Romosozumab 210 mg

Arm Description

Participants received romosozumab 140 mg administered subcutaneously once a month for 3 months.

Participants received romosozumab 210 mg administered subcutaneously once a month for 3 months.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine
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

Percent Change From Baseline in Bone Mineral Density (BMD) at the Femoral Neck
Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab.
Percent Change From Baseline in Bone Mineral Density (BMD) at the Total Hip
Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab.
Percent Change From Baseline in Serum Type-1 Aminoterminal Propeptide (P1NP)
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Number of Participants With Adverse Events
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.
Number of Participants Who Developed Anti-romosozumab Antibodies
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.
Mean Serum Concentration of Romosozumab

Full Information

First Posted
April 17, 2012
Last Updated
March 12, 2019
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01588509
Brief Title
Transition From Alendronate to Romosozumab (AMG 785)
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 30, 2012 (Actual)
Primary Completion Date
November 21, 2012 (Actual)
Study Completion Date
November 21, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
AMG 785, bone mineral density, alendronate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Romosozumab 140 mg
Arm Type
Experimental
Arm Description
Participants received romosozumab 140 mg administered subcutaneously once a month for 3 months.
Arm Title
Romosozumab 210 mg
Arm Type
Experimental
Arm Description
Participants received romosozumab 210 mg administered subcutaneously once a month for 3 months.
Intervention Type
Drug
Intervention Name(s)
Romosozumab
Other Intervention Name(s)
AMG 785, EVENITY™
Intervention Description
Administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine
Description
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.
Time Frame
Baseline and day 85
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Bone Mineral Density (BMD) at the Femoral Neck
Description
Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab.
Time Frame
Baseline and day 85
Title
Percent Change From Baseline in Bone Mineral Density (BMD) at the Total Hip
Description
Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab.
Time Frame
Baseline and day 85
Title
Percent Change From Baseline in Serum Type-1 Aminoterminal Propeptide (P1NP)
Time Frame
Baseline and days 4, 15, 29, 43, 57, 71, and 85
Title
Percent Change From Baseline in Serum C-telopeptide (sCTX)
Time Frame
Baseline and days 4, 15, 29, 43, 57, 71, and 85
Title
Number of Participants With Adverse Events
Description
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.
Time Frame
From first dose of study drug up to day 85
Title
Number of Participants Who Developed Anti-romosozumab Antibodies
Description
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.
Time Frame
Baseline and days 29, 57, and 85
Title
Mean Serum Concentration of Romosozumab
Time Frame
Days 4, 15, 29, 43, 57, 71 and 85

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Research Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Research Site
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Research Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Research Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Research Site
City
West Haverstraw
State/Province
New York
ZIP/Postal Code
10993
Country
United States
Facility Name
Research Site
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98144
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Transition From Alendronate to Romosozumab (AMG 785)

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