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Study Complete
Sponsor ID
20050172

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

Sponsor ID
20050172
Clinicaltrials.gov ID
NCT00306189
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 2
Product
denosumab
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
212
Additional Study Details

Protocol Summary

Primary Outcome Measures

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12

Timeframe: 12 months

Secondary Outcome Measures
Not Available

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
N/A - 80 Years
Condition
  • Osteoporosis
    • Sex
    Assigned Female at Birth
    Trial Dates
    Jan 2006 - Jun 2007
    Inclusion and Exclusion 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.