NCT01992159

Brief Summary

The purpose of this study is to determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal osteoporosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
252

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

27 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

October 12, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2015

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

March 25, 2019

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

November 19, 2013

Results QC Date

November 20, 2018

Last Update Submit

March 21, 2019

Conditions

Postmenopausal Osteoporosis (PMO)

Keywords

Osteoporosis, Osteoporosis-Postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases

Outcome Measures

Primary Outcomes (1)

  • Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine

    Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.

    Baseline and 12 months

Secondary Outcomes (10)

  • Percent Change From Baseline at 6 Months in Bone Mineral Density at the Lumbar Spine

    Baseline and 6 months

  • Percent Change From Baseline at 6 Months in Bone Mineral Density at the Total Hip

    Baseline and 6 months

  • Percent Change From Baseline to 12 Months in Bone Mineral Density at the Total Hip

    Baseline and 12 months

  • Percent Change From Baseline to 6 Months in Bone Mineral Density at the Femoral Neck

    Baseline and 6 months

  • Percent Change From Baseline to 12 Months in Bone Mineral Density at the Femoral Neck

    Baseline and 12 months

  • +5 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.

Drug: Placebo

Romosozumab 70 mg

EXPERIMENTAL

Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.

Drug: Romosozumab

Romosozumab 140 mg

EXPERIMENTAL

Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.

Drug: Romosozumab

Romosozumab 210 mg

EXPERIMENTAL

Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.

Drug: Romosozumab

Interventions

RomosozumabDRUG

Administered by subcutaneous injection

Also known as: AMG 785, EVENITY™
Romosozumab 140 mgRomosozumab 210 mgRomosozumab 70 mg
PlaceboDRUG

Administered by subcutaneous injection

Placebo

Eligibility Criteria

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

You may qualify if:

  • Ambulatory, postmenopausal Japanese women with osteoporosis (defined as bone mineral density T-score of ≤ -4.00 at the lumbar spine or BMD T-score of ≤ -3.50 at the total hip, or femoral neck)

You may not qualify if:

  • Severe osteoporosis
  • Use of agents affecting bone metabolism
  • History of metabolic or bone disease (except osteoporosis)
  • Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
  • Current hyper- or hypocalcemia
  • Current, uncontrolled hyper- or hypothyroidism
  • Current, uncontrolled hyper- or hypoparathyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Research Site

Anjyo-shi, Aichi-ken, 446-0063, Japan

Location

Research Site

Fukuoka, Fukuoka, 814-0165, Japan

Location

Research Site

Kitakyushu-shi, Fukuoka, 800-0057, Japan

Location

Research Site

Yanagawa-shi, Fukuoka, 832-0059, Japan

Location

Research Site

Mizunami-shi, Gifu, 509-6134, Japan

Location

Research Site

Sapporo, Hokkaido, 063-0814, Japan

Location

Research Site

Sapporo, Hokkaido, 065-0024, Japan

Location

Research Site

Morioka, Iwate, 020-0066, Japan

Location

Research Site

Yokohama, Kanagawa, 223-0062, Japan

Location

Research Site

Yokohama, Kanagawa, 231-0861, Japan

Location

Research Site

Kyoto, Kyoto, 602-8026, Japan

Location

Research Site

Sendai, Miyagi, 981-3132, Japan

Location

Research Site

Sendai, Miyagi, 983-0862, Japan

Location

Research Site

Saito-shi, Miyazaki, 881-0113, Japan

Location

Research Site

Matsumoto-shi, Nagano, 390-1401, Japan

Location

Research Site

Ueda-shi, Nagano, 386-0151, Japan

Location

Research Site

Ueda-shi, Nagano, 386-0405, Japan

Location

Research Site

Osaka, Osaka, 559-0011, Japan

Location

Research Site

Takatsuki-shi, Osaka, 569-1123, Japan

Location

Research Site

Kita-adachi-gun, Saitama, 362-0806, Japan

Location

Research Site

Hachioji-shi, Tokyo, 192-0046, Japan

Location

Research Site

Kiyose-shi, Tokyo, 204-0021, Japan

Location

Research Site

Minato-ku, Tokyo, 108-0075, Japan

Location

Research Site

Ōta-ku, Tokyo, 146-0094, Japan

Location

Research Site

Shinagawa-ku, Tokyo, 140-0011, Japan

Location

Research Site

Suginami-ku, Tokyo, 166-0003, Japan

Location

Research Site

Toshima-ku, Tokyo, 171-0033, Japan

Location

Related Publications (1)

  • Ishibashi H, Crittenden DB, Miyauchi A, Libanati C, Maddox J, Fan M, Chen L, Grauer A. Romosozumab increases bone mineral density in postmenopausal Japanese women with osteoporosis: A phase 2 study. Bone. 2017 Oct;103:209-215. doi: 10.1016/j.bone.2017.07.005. Epub 2017 Jul 5.

    PMID: 28687496BACKGROUND

Related Links

MeSH Terms

Conditions

Osteoporosis, PostmenopausalOsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal Diseases

Interventions

romosozumab

Condition Hierarchy (Ancestors)

Metabolic 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 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2013

First Posted

November 25, 2013

Study Start

October 12, 2012

Primary Completion

October 9, 2014

Study Completion

June 17, 2015

Last Updated

March 25, 2019

Results First Posted

March 25, 2019

Record last verified: 2019-03

Locations

JP(27)