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

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

MedlinePlus related topics:

Osteoporosis

Drug Information available for:

Lasofoxifene

U.S. FDA Resources

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

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 ]

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

Criteria

Inclusion Criteria:

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

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A2181042
First Received:	April 30, 2008
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00674453
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

ClinicalTrials.gov processed this record on October 23, 2008

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