The Prevention Of Postmenopausal Osteoporosis With Lasofoxifene And Cytokine Evaluation (LACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00674453
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : August 10, 2011
Information provided by:
Ligand Pharmaceuticals

Brief Summary:
The objective of the study is to demonstrate the effects that lasofoxifene has on serum markers of bone metabolism.

Condition or disease Intervention/treatment Phase
Bone Loss Drug: Lasofoxifene Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect Of Lasofoxifene On Local Mediators Of Bone Resorption In The Prevention Of Postmenopausal Osteoporosis
Study Start Date : September 2004
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lasofoxifene 0.25 mg/d Drug: Lasofoxifene
Oral tablet, 0.25 mg, daily, 2 years
Placebo Comparator: Placebo Other: Placebo
Matching placebo tablet given once daily for 2 years

Primary Outcome Measures :
  1. Change in bone mineral density of the lumbar spine. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  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. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00674453

United Kingdom
Pfizer Investigational Site
Sheffield, United Kingdom, S5 7AU
Sponsors and Collaborators
Ligand Pharmaceuticals
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Project Management, Ligand Pharmaceuticals Identifier: NCT00674453     History of Changes
Other Study ID Numbers: A2181042
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: August 10, 2011
Last Verified: August 2011

Keywords provided by Ligand Pharmaceuticals:
bone density
bone markers

Additional relevant MeSH terms:
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases