The Prevention Of Postmenopausal Osteoporosis With Lasofoxifene And Cytokine Evaluation
LACE
The Effect Of Lasofoxifene On Local Mediators Of Bone Resorption In The Prevention Of Postmenopausal Osteoporosis
1 other identifier
interventional
51
1 country
1
Brief Summary
The objective of the study is to demonstrate the effects that lasofoxifene has on serum markers of bone metabolism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2004
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 30, 2008
CompletedFirst Posted
Study publicly available on registry
May 7, 2008
CompletedAugust 10, 2011
August 1, 2011
April 30, 2008
August 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in bone mineral density of the lumbar spine.
2 years
Secondary Outcomes (1)
The secondary outcomes are the levels of cells and proteins in the blood that provide information about the health of bone, along with change in bone mineral density of the hip and forearm.
2 years
Study Arms (2)
Lasofoxifene 0.25 mg/d
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Postmenopausal women over 50 years who have low bone mineral density.
You may not qualify if:
- Women who are under 50 years of age, are premenopausal, or who currently have osteoporosis are excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pfizer Investigational Site
Sheffield, S5 7AU, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 30, 2008
First Posted
May 7, 2008
Study Start
September 1, 2004
Study Completion
September 1, 2007
Last Updated
August 10, 2011
Record last verified: 2011-08