NCT02157948CompletedPhase 3
A Multicenter, Double-blind, Randomized Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 394
- Locations
- 1
- Primary Endpoint
- Percent Change From Baseline in Lumbar Spine BMD
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 55 Years to 100 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Denosumab CP2
Active Comparator
Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
Intervention: Denosumab (CP2) (Drug)
Denosumab CP4
Experimental
Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
Intervention: Denosumab (CP4) (Drug)
Outcomes
Primary Outcomes
Percent Change From Baseline in Lumbar Spine BMD
Time Frame: Baseline and Month 12
Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Secondary Outcomes
- Percent Change From Baseline in Serum Type I Collagen C-telopeptide (sCTX)(Baseline, month 1, month 6 and month 12)
- Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)(Baseline, month 1, month 6 and month 12)
Investigators
Study Sites (1)
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