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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00306189
First received: March 21, 2006
Last updated: June 13, 2013
Last verified: June 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 -

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.


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
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

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

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00306189     History of Changes
Other Study ID Numbers: 20050172, NOT APPRICABLE
Study First Received: March 21, 2006
Results First Received: December 22, 2009
Last Updated: June 13, 2013
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

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 31, 2014