A Study of Arzoxifene to Treat Korean Women With Osteoporosis

NCT00767299 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2015-04-30

No results posted yet for this study

Summary

The study is for Korean women who are postmenopausal and also suffer from osteoporosis.

The study will test if women who are given 20 mg of arzoxifene once a day for six months have a less severe level of osteoporosis than those women who do not take arzoxifene.

All patients will receive 500 mg of elemental calcium and 400 to 600 IU Vitamin D daily starting 4 weeks prior to study drug administration continuing through the 6 months of therapy.

Conditions

Interventions

DRUG

arzoxifene

20 mg, QD, PO,24 weeks

DRUG

Placebo

QD, PO, 24 weeks

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00767299 on ClinicalTrials.gov