Back to Search Results
Study Complete
Sponsor ID
20050179

A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment with Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women with Low Bone Mineral Density

Sponsor ID
20050179
Clinicaltrials.gov ID
NCT00293813
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

Study Details

This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.

Additional Study Details

Phase
Phase 2
Product
denosumab
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
247
Additional Study Details

Protocol Summary

Primary Outcome Measures

Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12

Timeframe: 12 months

Secondary Outcome Measures

Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12

Timeframe: 12 months

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
50 - 70 Years
Condition
  • Osteoporosis
    • Sex
    Assigned Female at Birth
    Trial Dates
    May 2006 - Mar 2008
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    -Postmenopausal, ambulatory women between 50 and 70 years old who are generally in good health. -Must have low bone mineral density and meet specific eligibility criteria.
    Exclusion Criteria:
    -Subjects must not currently be receiving any medication that affects bone metabolism or have an underlying condition that affects their ability to take alendronate or receive denosumab.