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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01992159
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis (PMO) Drug: Romosozumab Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
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
Actual Study Start Date : October 12, 2012
Primary Completion Date : October 9, 2014
Study Completion Date : June 17, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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™


Outcome Measures

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

Secondary Outcome Measures :
  1. • Change in Bone Mineral Density at the lumbar spine from Baseline to Month 6 [ Time Frame: 6 months ]
  2. • Change in Bone Mineral Density at the total hip and femoral neck from Baseline to Month 6 [ Time Frame: 6 months ]
  3. • Change in Bone Mineral Density at the total hip and femoral neck from Baseline to Month 12 [ Time Frame: 12 months ]
  4. • 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 ]
  5. • Analysis of the P1NP bone marker through Month 12 [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01992159     History of Changes
Other Study ID Numbers: 20101291
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 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
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs