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Study Complete
Sponsor ID
20120187

A double-blind study to assess the efficacy and safety of denosumab produced by two different processes in postmenopausal women with osteoporosis

Sponsor ID
20120187
Clinicaltrials.gov ID
NCT02157948
EUCTIS ID
N/A
EudraCT ID
2013-001279-19
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Study Details

This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.

Additional Study Details

Phase
Phase 3
Product
denosumab
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
394
Additional Study Details

Protocol Summary

Primary Outcome Measures

Bone Mineral Density (BMD) by Dual-Energy X-ray Absorptiometry (DXA) at the lumbar spine

Timeframe: 12 months

Secondary Outcome Measures

Serum concentration of biomarkers of Bone Turnover (CTX and P1NP)

Timeframe: 12 months

Locations

Location
Status
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Location
Research Site
Gainesville, GA, United States, 30501
Status
Recruiting
Location
Research Site
Akron, OH, United States, 44311
Status
Recruiting
Location
Research Site
Lakewood, CO, United States, 80227
Status
Recruiting
Location
Research Site
Bethesda, MD, United States, 20817
Status
Recruiting
Location
Research Site
Vancouver, BC, Canada, V5Z 4E1
Status
Recruiting
Location
Research Site
Westmout, QC, Canada, H3Z 1E5
Status
Recruiting
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Study Info
Age
55 - 100 Years
Condition
  • Osteoporosis
    • Sex
    Assigned Female at Birth
    Trial Dates
    May 2014 - Jul 2015
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Subject has provided informed consent prior to any study-specific activities/procedures - Ambulatory postmenopausal women. - Age 55 years or older - Screening BMD value equivalent to a T-score less than or equal to -2.5 at the lumbar spine, total hip, or femoral neck.
    Exclusion Criteria:
    - Administration of osteoporosis treatments or bone active treatments within specific timeframes - Vitamin D deficiency - Diseases and conditions that affect bone metabolism (e.g., hypo/hyper-parathyroidism; hypo/hyperthyroidism, unless stable and well-controlled) - Contraindications to denosumab therapy (e.g., hypocalcemia)