Back to resultsThe Prevention Of Postmenopausal Osteoporosis With Lasofoxifene And Cytokine Evaluation (LACE)
Primary Purpose
Bone Loss
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Lasofoxifene
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Bone Loss focused on measuring Osteoporosis, lasofoxifene, bone density, bone markers
Eligibility Criteria
Inclusion Criteria:
- Postmenopausal women over 50 years who have low bone mineral density.
Exclusion Criteria:
- Women who are under 50 years of age, are premenopausal, or who currently have osteoporosis are excluded.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lasofoxifene 0.25 mg/d
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in bone mineral density of the lumbar spine.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00674453
Brief Title
The Prevention Of Postmenopausal Osteoporosis With Lasofoxifene And Cytokine Evaluation
Acronym
LACE
Official Title
The Effect Of Lasofoxifene On Local Mediators Of Bone Resorption In The Prevention Of Postmenopausal Osteoporosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ligand Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the study is to demonstrate the effects that lasofoxifene has on serum markers of bone metabolism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss
Keywords
Osteoporosis, lasofoxifene, bone density, bone markers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lasofoxifene 0.25 mg/d
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lasofoxifene
Intervention Description
Oral tablet, 0.25 mg, daily, 2 years
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablet given once daily for 2 years
Primary Outcome Measure Information:
Title
Change in bone mineral density of the lumbar spine.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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.
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Postmenopausal women over 50 years who have low bone mineral density.
Exclusion Criteria:
Women who are under 50 years of age, are premenopausal, or who currently have osteoporosis are excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2181042&StudyName=The%20Prevention%20Of%20Postmenopausal%20Osteoporosis%20with%20Lasofoxifene%20And%20Cytokine%20Evaluation
Description
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Learn more about this trial
The Prevention Of Postmenopausal Osteoporosis With Lasofoxifene And Cytokine Evaluation
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