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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00674453
First Posted: May 7, 2008
Last Update Posted: August 10, 2011
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.
Information provided by:
Ligand Pharmaceuticals
  Purpose
The objective of the study is to demonstrate the effects that lasofoxifene has on serum markers of bone metabolism.

Condition Intervention Phase
Bone Loss Drug: Lasofoxifene Other: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ligand Pharmaceuticals:

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

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. [ Time Frame: 2 years ]

Enrollment: 51
Study Start Date: September 2004
Study Completion Date: September 2007
Arms Assigned Interventions
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

  Eligibility

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
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00674453


Locations
United Kingdom
Pfizer Investigational Site
Sheffield, United Kingdom, S5 7AU
Sponsors and Collaborators
Ligand Pharmaceuticals
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Project Management, Ligand Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00674453     History of Changes
Other Study ID Numbers: A2181042
First Submitted: April 30, 2008
First Posted: May 7, 2008
Last Update Posted: August 10, 2011
Last Verified: August 2011

Keywords provided by Ligand Pharmaceuticals:
Osteoporosis
lasofoxifene
bone density
bone markers

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