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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
Results First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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
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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
Actual Primary Completion Date : October 9, 2014
Actual Study Completion Date : June 17, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Romosozumab

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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 ]
  7. 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 ]
  8. Percent Change From Baseline in Osteocalcin [ Time Frame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12 ]
  9. Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) [ Time Frame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12 ]
  10. Area Under the Curve Through Month 12 of P1NP [ Time Frame: Baseline, week 1 and months 1, 2, 3, 6, 9, and 12. ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
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
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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
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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
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Study Director: MD Amgen
More Information
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Additional Information:

Publications:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01992159    
Other Study ID Numbers: 20101291
First Posted: November 25, 2013    Key Record Dates
Results First Posted: March 25, 2019
Last Update Posted: March 25, 2019
Last Verified: March 2019
Keywords provided by Amgen:
Osteoporosis, Osteoporosis-Postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
 Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases