NCT01588509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2012

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

March 4, 2019

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

8 months

First QC Date

April 17, 2012

Results QC Date

September 24, 2018

Last Update Submit

March 12, 2019

Conditions

Osteoporosis

Keywords

AMG 785, bone mineral density, alendronate

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and day 85

Secondary Outcomes (7)

  • Percent Change From Baseline in Bone Mineral Density (BMD) at the Femoral Neck

    Baseline and day 85

  • Percent Change From Baseline in Bone Mineral Density (BMD) at the Total Hip

    Baseline and day 85

  • Percent Change From Baseline in Serum Type-1 Aminoterminal Propeptide (P1NP)

    Baseline and days 4, 15, 29, 43, 57, 71, and 85

  • Percent Change From Baseline in Serum C-telopeptide (sCTX)

    Baseline and days 4, 15, 29, 43, 57, 71, and 85

  • Number of Participants With Adverse Events

    From first dose of study drug up to day 85

  • +2 more secondary outcomes

Study Arms (2)

Romosozumab 140 mg

EXPERIMENTAL

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

Drug: Romosozumab

Romosozumab 210 mg

EXPERIMENTAL

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

Drug: Romosozumab

Interventions

RomosozumabDRUG

Administered by subcutaneous injection

Also known as: AMG 785, EVENITY™
Romosozumab 140 mgRomosozumab 210 mg

Eligibility Criteria

Age55 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Research Site

Tucson, Arizona, 85711, United States

Location

Research Site

Walnut Creek, California, 94598, United States

Location

Research Site

Gainesville, Georgia, 30501, United States

Location

Research Site

Honolulu, Hawaii, 96813, United States

Location

Research Site

Bethesda, Maryland, 20817, United States

Location

Research Site

Albuquerque, New Mexico, 87106, United States

Location

Research Site

West Haverstraw, New York, 10993, United States

Location

Research Site

Wyomissing, Pennsylvania, 19610, United States

Location

Research Site

Seattle, Washington, 98144, United States

Location

Related Links

MeSH Terms

Conditions

Osteoporosis

Interventions

romosozumab

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
medinfo@amgen.com
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2012

First Posted

May 1, 2012

Study Start

March 30, 2012

Primary Completion

November 21, 2012

Study Completion

November 21, 2012

Last Updated

March 26, 2019

Results First Posted

March 4, 2019

Record last verified: 2019-03

Locations

US(9)