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

Primary Purpose

Postmenopausal Osteoporosis (PMO)

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Romosozumab
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis (PMO) focused on measuring Osteoporosis, Osteoporosis-Postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases

Eligibility Criteria

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

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

Sites / Locations

  • Research Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Romosozumab 70 mg

Romosozumab 140 mg

Romosozumab 210 mg

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 19, 2013
Last Updated
March 21, 2019
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01992159
Brief Title
Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 12, 2012 (Actual)
Primary Completion Date
October 9, 2014 (Actual)
Study Completion Date
June 17, 2015 (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 determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal osteoporosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis (PMO)
Keywords
Osteoporosis, Osteoporosis-Postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
Arm Title
Romosozumab 70 mg
Arm Type
Experimental
Arm Description
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Arm Title
Romosozumab 140 mg
Arm Type
Experimental
Arm Description
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Arm Title
Romosozumab 210 mg
Arm Type
Experimental
Arm Description
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Intervention Type
Drug
Intervention Name(s)
Romosozumab
Other Intervention Name(s)
AMG 785, EVENITY™
Intervention Description
Administered by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine
Description
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Percent Change From Baseline at 6 Months in Bone Mineral Density at the Lumbar Spine
Description
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Time Frame
Baseline and 6 months
Title
Percent Change From Baseline at 6 Months in Bone Mineral Density at the Total Hip
Description
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Time Frame
Baseline and 6 months
Title
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Total Hip
Description
Bone density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Time Frame
Baseline and 12 months
Title
Percent Change From Baseline to 6 Months in Bone Mineral Density at the Femoral Neck
Description
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Time Frame
Baseline and 6 months
Title
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Femoral Neck
Description
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Time Frame
Baseline and 12 months
Title
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
Title
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
Title
Percent Change From Baseline in Osteocalcin
Time Frame
Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Title
Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)
Time Frame
Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Title
Area Under the Curve Through Month 12 of P1NP
Time Frame
Baseline, week 1 and months 1, 2, 3, 6, 9, and 12.

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
28687496
Citation
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.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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