The Prevention Of Postmenopausal Osteoporosis With Lasofoxifene And Cytokine Evaluation

Phase 2CompletedNCT00674453

Ligand Pharmaceuticals51 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Bone Loss

Interventions

LasofoxifeneDRUG

Oral tablet, 0.25 mg, daily, 2 years

PlaceboOTHER

Matching placebo tablet given once daily for 2 years

Eligibility

Sex: FEMALEMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Sheffield, United Kingdom

Outcomes

Primary Outcomes

Change in bone mineral density of the lumbar spine.

Time frame: 2 years

Secondary Outcomes

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

Data from ClinicalTrials.gov

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