The Prevention Of Postmenopausal Osteoporosis With Lasofoxifene And Cytokine Evaluation - Full Text View

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

This study has been completed.

First Received: April 30, 2008 Last Updated: May 1, 2008 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00674453

Purpose

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

Condition	Intervention	Phase
Osteoporosis	Drug: Lasofoxifene Other: Placebo	Phase II

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Pharmacodynamics Study
Official Title:	The Effect Of Lasofoxifene On Local Mediators Of Bone Resorption In The Prevention Of Postmenopausal Osteoporosis

Resource links provided by NLM:

MedlinePlus related topics: Minerals Osteoporosis

Drug Information available for: Lasofoxifene

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change in bone mineral density of the lumbar spine. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Enrollment:	51
Study Start Date:	September 2004
Study Completion Date:	September 2007

Arms	Assigned Interventions
Lasofoxifene 0.25 mg/d: Experimental	Drug: Lasofoxifene Oral tablet, 0.25 mg, daily, 2 years
Placebo: Placebo Comparator	Other: Placebo Matching placebo tablet given once daily for 2 years

Eligibility

Ages Eligible for Study:	50 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674453

Locations

United Kingdom
Pfizer Investigational Site
Sheffield, United Kingdom, S5 7AU

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A2181042
Study First Received:	April 30, 2008
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00674453 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Pfizer:

Osteoporosis lasofoxifene bone density bone markers

Study placed in the following topic categories:

Musculoskeletal Diseases
Bone Resorption
Osteoporosis, Postmenopausal

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoporosis, Postmenopausal
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on September 10, 2009