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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01992159
First received: November 19, 2013
Last updated: May 31, 2017
Last verified: May 2017
  Purpose
The purpose of this study is to determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal osteoporosis.

Condition Intervention Phase
Postmenopausal Osteoporosis (PMO) Drug: Romosozumab Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • • Change in Bone Mineral Density at the lumbar spine from Baseline to 12 Months [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • • Change in Bone Mineral Density at the lumbar spine from Baseline to Month 6 [ Time Frame: 6 months ]
  • • Change in Bone Mineral Density at the total hip and femoral neck from Baseline to Month 6 [ Time Frame: 6 months ]
  • • Change in Bone Mineral Density at the total hip and femoral neck from Baseline to Month 12 [ Time Frame: 12 months ]
  • • Change in bone markers from baseline at Day 1 plus 1 week, Month 1, Month 2, Month 3, Month 6, Month 9 and Month 12 [ Time Frame: 12 months ]
  • • Analysis of the P1NP bone marker through Month 12 [ Time Frame: 12 months ]

Enrollment: 252
Actual Study Start Date: October 12, 2012
Study Completion Date: June 17, 2015
Primary Completion Date: October 9, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
Drug: Placebo
Administered by subcutaneous injection
Experimental: Romosozumab 70 mg
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Drug: Romosozumab
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.
Drug: Romosozumab
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.
Drug: Romosozumab
Administered by subcutaneous injection
Other Names:
  • AMG 785
  • EVENITY™

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01992159

Locations
Japan
Research Site
Anjyo-shi, Aichi, Japan, 446-0063
Research Site
Fukuoka-shi, Fukuoka, Japan, 814-0165
Research Site
Kitakyushu-shi, Fukuoka, Japan, 800-0057
Research Site
Yanagawa-shi, Fukuoka, Japan, 832-0059
Research Site
Mizunami-shi, Gifu, Japan, 509-6134
Research Site
Sapporo-shi, Hokkaido, Japan, 063-0814
Research Site
Sapporo-shi, Hokkaido, Japan, 065-0024
Research Site
Morioka-shi, Iwate, Japan, 020-0066
Research Site
Yokohama-shi, Kanagawa, Japan, 223-0062
Research Site
Yokohama-shi, Kanagawa, Japan, 231-0861
Research Site
Kyoto-shi, Kyoto, Japan, 602-8026
Research Site
Sendai-shi, Miyagi, Japan, 981-3132
Research Site
Sendai-shi, Miyagi, Japan, 983-0862
Research Site
Saito-shi, Miyazaki, Japan, 881-0113
Research Site
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-shi, Osaka, Japan, 559-0011
Research Site
Takatsuki-shi, Osaka, Japan, 569-1123
Research Site
Kita-adachi-gun, Saitama, Japan, 362-0806
Research Site
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
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01992159     History of Changes
Other Study ID Numbers: 20101291
Study First Received: November 19, 2013
Last Updated: May 31, 2017

Keywords provided by Amgen:
Osteoporosis, Osteoporosis-Postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017