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OpenTrials
Completed

NCT Number: NCT00674453

The Prevention Of Postmenopausal Osteoporosis With Lasofoxifene And Cytokine Evaluation

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

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Key information

Conditions

Bone Loss Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site

Sheffield, S5 7AU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lasofoxifene

Drug

Oral tablet, 0.25 mg, daily, 2 years

Placebo

Other

Matching placebo tablet given once daily for 2 years

Primary outcomes

  1. Change in bone mineral density of the lumbar spine.

    Time frame: 2 years

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ligand Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: LACE

Important dates

Study start
2004
Study completion
2007
First posted
May 7, 2008
Registry last updated
Aug 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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