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Study Complete
Sponsor ID
20101217

Efficacy and Safety of Denosumab Compared with Risedronate in Individuals Taking GlucocorticoidsGIOP

Sponsor ID
20101217
Clinicaltrials.gov ID
NCT01575873
EUCTIS ID
N/A
EudraCT ID
2010-024393-19
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Study Details

This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with glucocorticoid-induced osteoporosis.

Additional Study Details

Phase
Phase 3
Product
denosumab
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
795
Additional Study Details

Protocol Summary

Primary Outcome Measures

Bone Mineral Density

Timeframe: 12 months

Secondary Outcome Measures

Bone Mineral Density

Timeframe: 12 and 24 months

Bone histology

Timeframe: 12 and 24 Months

Bone histomorphometry

Timeframe: 12 & 24 Months

Study Documents

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

Locations

Location
Status
Contact Us
Location
Research Site
Vancouver, BC, Canada, V5Z 4E1
Status
Recruiting
Location
Research Site
Bethesda, MD, United States, 20817
Status
Recruiting
Location
Research Site
Quebec, QC, Canada, G1V 3M7
Status
Recruiting
Location
Research Site
Trois-Rivieres, QC, Canada, G8Z 1Y2
Status
Recruiting
Location
Research Site
Lakewood, CO, United States, 80227
Status
Recruiting
Location
Research Site
Hamilton, ON, Canada, L8N 1Y2
Status
Recruiting
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Study Info
Age
18+ years
Condition
  • Osteoporosis
    • Sex
    All
    Trial Dates
    Mar 2012 - Jun 2016
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Men and women 18 years of age or older who have been taking glucocorticoid treatment. Men and women who are less than 50 years of age must have had a fracture as an adult to be eligible. Men and women who are 50 years of age or older who have been taking glucocorticoids must meet protocol-specific BMD criteria.
    Exclusion Criteria:
    Use of agents affecting bone metabolism, use of more than one biologic agent for inflammatory disease, history of bone disease (except osteoporosis), low vitamin D level (one can enter the trial after vitamin D levels are corrected), abnormalities of blood calcium, an underactive or overactive thyroid condition that is not treated and stable, Addison's disease, any abnormality of the parathyroid glands (the glands that control blood calcium), currently pregnant or planning a pregnancy, currently breast feeding, and other criteria may apply.