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The 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
Ligand Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bone Loss focused on measuring Osteoporosis, lasofoxifene, bone density, bone markers

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
April 30, 2008
Last Updated
August 8, 2011
Sponsor
Ligand Pharmaceuticals
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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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The Prevention Of Postmenopausal Osteoporosis With Lasofoxifene And Cytokine Evaluation

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