A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00306189

Purpose

The primary objective of this study is to assess the effect of AMG 162 (denosumab) treatment on the lumbar spine BMD at month 12 and safety profile across the dose range tested (14, 60 and 100 mg SC once every 6 months) in Japanese postmenopausal osteoporotic subjects compared with those treated with placebo over 12 months.

Condition	Intervention	Phase
Osteoporosis	Drug: 100 mg AMG 162 Drug: 60 mg AMG 162 Drug: 14 mg AMG 162 Drug: Placebo	Phase II

Study Type:

Interventional

Study Design:

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Official Title:

Dose Response Study of AMG 162 (Denosumab) in Subjects With Osteoporosis - A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects

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Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Denosumab

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

the percent change of lumbar spine BMD between baseline and month 12 and the subject incidence of the treatment-emergent adverse events for the placebo and AMG 162 (denosumab) treatment arms over 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Percent change of lumbar spine BMD at month 1, month 3, and month 6 [ Time Frame: month 1, month 3 and month 6 ] [ Designated as safety issue: No ]

Enrollment:	212
Study Start Date:	January 2006
Study Completion Date:	November 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
100 mg AMG 162: Active Comparator	Drug: 100 mg AMG 162 100 mg AMG 162 (denosumab) SC every 6 months
60 mg AMG 162: Active Comparator	Drug: 60 mg AMG 162 60 mg AMG 162 (denosumab) SC every 6 months
Placebo: Placebo Comparator	Drug: Placebo Placebo SC every 6 months
14 mg AMG 162: Active Comparator	Drug: 14 mg AMG 162 14 mg AMG 162 (denosumab) SC every 6 months

Eligibility

Ages Eligible for Study:	up to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: - Ambulatory postmenopausal women. - BMD values (g/cm2, Hologic) must be lower than 0.714 at lumbar spine, 0.515 at femoral neck, 0.588 at total hip. - BMD values must not be lower than 0.535 at the lumbar spine, 0.406 at the femoral neck and 0.478 at the total hip. Exclusion Criteria: - Oral bisphosphonate treatments, PTH or PTH derivatives use within the last 12 months and administration of any of anti-osteoporotic treatments within the last 3 months before initial administration of the investigational product. - History of hypocalcemia. - More than two moderate vertebral fractures or any severe vertebral fracture.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306189

Locations

Japan
Research Site
Shinagawa, Tokyo, Japan
Research Site
Asahikawa, Hokkaido, Japan
Research Site
Fukuoka, Fkuoka, Japan
Research Site
Saga, Saga, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Nagoya, Aichi, Japan
Research Site
Onga-gun, Fukuoka, Japan
Research Site
KitaKyushu, Fukuoka, Japan
Research Site
Yukuhashi,Hukuoka, Japan
Research Site
Iruma, Saitama, Japan
Research Site
Fukui, Fukui, Japan
Research Site
Fukui, Fuki, Japan
Research Site
Meguro-ku, Tokyo, Japan
Research Site
Tamana, Kumamoto, Japan
Research Site
Chitose, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Hachioji, Tokyo, Japan
Research Site
Kagoshima, Kagoshima, Japan
Research Site
Miyazaki, Miyazaki, Japan

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20050172, NOT APPRICABLE
Study First Received:	March 21, 2006
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00306189 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Amgen:

RANKL
RANK
denosumab
AMG 162

osteoporosis
bone turnover
bone mineral density
Japanese

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on September 11, 2009