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

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ClinicalTrials.gov Identifier: NCT00306189
Recruitment Status : Completed
First Posted : March 23, 2006
Results First Posted : January 27, 2010
Last Update Posted : June 20, 2013
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoporosis Drug: 100 mg AMG 162 Drug: 60 mg AMG 162 Drug: 14 mg AMG 162 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 -
Study Start Date : January 2006
Primary Completion Date : June 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
Drug Information available for: Denosumab
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 100 mg AMG 162 Drug: 100 mg AMG 162
100 mg AMG 162 (denosumab) SC every 6 months
Active Comparator: 60 mg AMG 162 Drug: 60 mg AMG 162
60 mg AMG 162 (denosumab) SC every 6 months
Placebo Comparator: Placebo Drug: Placebo
Placebo SC every 6 months
Active Comparator: 14 mg AMG 162 Drug: 14 mg AMG 162
14 mg AMG 162 (denosumab) SC every 6 months



Primary Outcome Measures :
  1. Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 [ Time Frame: 12 months ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes 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.

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): NCT00306189


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00306189     History of Changes
Other Study ID Numbers: 20050172
NOT APPRICABLE
First Posted: March 23, 2006    Key Record Dates
Results First Posted: January 27, 2010
Last Update Posted: June 20, 2013
Last Verified: June 2013

Keywords provided by Amgen:
RANKL
RANK
denosumab
AMG 162
osteoporosis
bone turnover
bone mineral density
Japanese

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs