Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis

March 21, 2019 updated by: Amgen

A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis

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

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Aichi
      • Anjyo-shi, Aichi, Japan, 446-0063
        • Research Site
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 814-0165
        • Research Site
      • Kitakyushu-shi, Fukuoka, Japan, 800-0057
        • Research Site
      • Yanagawa-shi, Fukuoka, Japan, 832-0059
        • Research Site
    • Gifu
      • Mizunami-shi, Gifu, Japan, 509-6134
        • Research Site
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 063-0814
        • Research Site
      • Sapporo-shi, Hokkaido, Japan, 065-0024
        • Research Site
    • Iwate
      • Morioka-shi, Iwate, Japan, 020-0066
        • Research Site
    • Kanagawa
      • Yokohama-shi, Kanagawa, Japan, 223-0062
        • Research Site
      • Yokohama-shi, Kanagawa, Japan, 231-0861
        • Research Site
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 602-8026
        • Research Site
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 981-3132
        • Research Site
      • Sendai-shi, Miyagi, Japan, 983-0862
        • Research Site
    • Miyazaki
      • Saito-shi, Miyazaki, Japan, 881-0113
        • Research Site
    • Nagano
      • Matsumoto-shi, Nagano, Japan, 390-1401
        • Research Site
      • Ueda-shi, Nagano, Japan, 386-0151
        • Research Site
      • Ueda-shi, Nagano, Japan, 386-0405
        • Research Site
    • Osaka
      • Osaka-shi, Osaka, Japan, 559-0011
        • Research Site
      • Takatsuki-shi, Osaka, Japan, 569-1123
        • Research Site
    • Saitama
      • Kita-adachi-gun, Saitama, Japan, 362-0806
        • Research Site
    • Tokyo
      • Hachioji-shi, Tokyo, Japan, 192-0046
        • Research Site
      • Kiyose-shi, Tokyo, Japan, 204-0021
        • Research Site
      • Minato-ku, Tokyo, Japan, 108-0075
        • Research Site
      • Ota-ku, Tokyo, Japan, 146-0094
        • Research Site
      • Shinagawa-ku, Tokyo, Japan, 140-0011
        • Research Site
      • Suginami-ku, Tokyo, Japan, 166-0003
        • Research Site
      • Toshima-ku, Tokyo, Japan, 171-0033
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
Administered by subcutaneous injection
Experimental: Romosozumab 70 mg
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Administered by subcutaneous injection
Other Names:
  • AMG 785
  • EVENITY™
Experimental: Romosozumab 140 mg
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Administered by subcutaneous injection
Other Names:
  • AMG 785
  • EVENITY™
Experimental: Romosozumab 210 mg
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Administered by subcutaneous injection
Other Names:
  • AMG 785
  • EVENITY™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine
Time Frame: Baseline and 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline at 6 Months in Bone Mineral Density at the Lumbar Spine
Time Frame: Baseline and 6 months
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Baseline and 6 months
Percent Change From Baseline at 6 Months in Bone Mineral Density at the Total Hip
Time Frame: Baseline and 6 months
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Baseline and 6 months
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Total Hip
Time Frame: Baseline and 12 months
Bone density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Baseline and 12 months
Percent Change From Baseline to 6 Months in Bone Mineral Density at the Femoral Neck
Time Frame: Baseline and 6 months
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Baseline and 6 months
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Femoral Neck
Time Frame: Baseline and 12 months
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
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
Time Frame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
Time Frame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Percent Change From Baseline in Osteocalcin
Time Frame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)
Time Frame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Area Under the Curve Through Month 12 of P1NP
Time Frame: Baseline, week 1 and months 1, 2, 3, 6, 9, and 12.
Baseline, week 1 and months 1, 2, 3, 6, 9, and 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2012

Primary Completion (Actual)

October 9, 2014

Study Completion (Actual)

June 17, 2015

Study Registration Dates

First Submitted

November 19, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

March 25, 2019

Last Update Submitted That Met QC Criteria

March 21, 2019

Last Verified

March 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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