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

This study has been completed.
Sponsor:
Information provided by:
Ligand Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00674453
First received: April 30, 2008
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Bone Loss
Drug: Lasofoxifene
Other: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Ligand Pharmaceuticals:

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
Experimental: Lasofoxifene 0.25 mg/d Drug: Lasofoxifene
Oral tablet, 0.25 mg, daily, 2 years
Placebo Comparator: Placebo 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Ligand Pharmaceuticals
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Project Management, Ligand Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00674453     History of Changes
Other Study ID Numbers: A2181042
Study First Received: April 30, 2008
Last Updated: August 8, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Ligand Pharmaceuticals:
Osteoporosis
lasofoxifene
bone density
bone markers

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014