A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
A Multicenter, Double-blind, Randomized Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
2 other identifiers
interventional
394
4 countries
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2014
Shorter than P25 for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 4, 2014
CompletedFirst Posted
Study publicly available on registry
June 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
August 16, 2017
CompletedAugust 16, 2017
July 1, 2017
1.2 years
June 4, 2014
July 18, 2017
July 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Lumbar Spine BMD
Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Baseline and Month 12
Secondary Outcomes (2)
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
Study Arms (2)
Denosumab CP2
ACTIVE COMPARATORParticipants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
Denosumab CP4
EXPERIMENTALParticipants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
Interventions
Denosumab produced by a process referred to as CP2, administered subcutaneously from a prefilled syringe.
Denosumab produced by a process referred to as CP4, administered subcutaneously from a prefilled syringe.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (23)
Research Site
Santa Maria, California, 93454, United States
Research Site
South Lake Tahoe, California, 96150, United States
Research Site
Lakewood, Colorado, 80227, United States
Research Site
Gainesville, Georgia, 30501, United States
Research Site
Bethesda, Maryland, 20817, United States
Research Site
Detroit, Michigan, 48236, United States
Research Site
Albuquerque, New Mexico, 87106, United States
Research Site
Akron, Ohio, 44311, United States
Research Site
Bend, Oregon, 97701, United States
Research Site
Duncansville, Pennsylvania, 16635, United States
Research Site
Vancouver, British Columbia, V5Z 4E1, Canada
Research Site
Québec, Quebec, G1V 3M7, Canada
Research Site
Westmout, Quebec, H3Z 1E5, Canada
Research Site
Aalborg, 9000, Denmark
Research Site
Ballerup Municipality, 2750, Denmark
Research Site
Vejle, 7100, Denmark
Research Site
Bialystok, 15-351, Poland
Research Site
Gliwice, 44-100, Poland
Research Site
Krakow, 31-501, Poland
Research Site
Lodz, 90-368, Poland
Research Site
Lodz, 90-558, Poland
Research Site
Świdnik, 21-040, Poland
Research Site
Warsaw, 04-730, Poland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2014
First Posted
June 6, 2014
Study Start
May 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
August 16, 2017
Results First Posted
August 16, 2017
Record last verified: 2017-07