The Prevention Of Postmenopausal Osteoporosis With Lasofoxifene And Cytokine Evaluation

Phase 2

Completed

• Conditions: Bone Loss
• Interventions: Other: Placebo; Drug: Lasofoxifene

• Registration Number: NCT00674453
• Lead Sponsor: Ligand Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study Completion: 2007-09
• Study First Submitted: 2008-04-30
• Study First Submitted QC: 2008-05-01
• Study First Posted: 2008-05-07
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-08
• Last Update Posted: 2011-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Lasofoxifene 0.25 mg/d	Lasofoxifene	-

Primary Outcome Measures

Name	Time	Method
Change in bone mineral density of the lumbar spine.	2 years

Secondary Outcome Measures

Name	Time	Method
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.	2 years

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Sheffield, United Kingdom