CClinicalTrials.gg
CompletedNCT00674453LACEUpdated Aug 10, 2011

The Prevention Of Postmenopausal Osteoporosis With Lasofoxifene And Cytokine Evaluation

A Phase 2 interventional study of Lasofoxifene and Placebo in Bone Loss, sponsored by Ligand Pharmaceuticals. Completed at 1 site in United Kingdom. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2011-08-10.

Sponsored by Ligand Pharmaceuticals · Phase 2, Interventional, and Basic science

Phase
Phase 2
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
50 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Bone Loss

Keywords

  • Osteoporosis
  • lasofoxifene
  • bone density
  • bone markers
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 51 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Ligand Pharmaceuticals is the lead sponsor of 21 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Postmenopausal women over 50 years who have low bone mineral density.

Exclusion criteria

Exclusion Criteria:

  • Women who are under 50 years of age, are premenopausal, or who currently have osteoporosis are excluded.
05

Study design

Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    Lasofoxifene 0.25 mg/d

    Drug: Lasofoxifene

  • Placebo comparator
    Placebo

    Other: Placebo

Interventions

  • DrugLasofoxifene

    Oral tablet, 0.25 mg, daily, 2 years

  • OtherPlacebo

    Matching placebo tablet given once daily for 2 years

06

What researchers measure

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

07

Study locations

1 site
  • Pfizer Investigational Site
    Sheffield, S5 7AU, United Kingdom
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00674453
Lead sponsor
Ligand Pharmaceuticals
First posted
May 7, 2008
Start date
Sep 2004
Completion
Sep 2007
Last update
Aug 10, 2011

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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