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NCT00674453 Clinical Trial

The Prevention Of Postmenopausal Osteoporosis With Lasofoxifene And Cytokine Evaluation

Bone Loss Clinical Trial

— LACE  

Official title:
The Effect Of Lasofoxifene On Local Mediators Of Bone Resorption In The Prevention Of Postmenopausal Osteoporosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00674453
Other study ID # A2181042
Secondary ID
Status Completed
Phase Phase 2
First received April 30, 2008
Last updated August 8, 2011
Start date September 2004
Est. completion date September 2007

Study information
Verified date August 2011
Source Ligand Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 50 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Lasofoxifene
Oral tablet, 0.25 mg, daily, 2 years
Other:
• Placebo
Matching placebo tablet given once daily for 2 years

Locations
Country Name City State
United Kingdom Pfizer Investigational Site Sheffield

Sponsors (1)
Lead Sponsor Collaborator
Ligand Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in bone mineral density of the lumbar spine. 2 years No
Secondary 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 No
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