Completed

Effects of Arzoxifene on Bone Mass and the Uterus

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What is being tested

Arzoxifene

+ Placebo
Drug
Who is being recruted

Postmenopausal Bone Loss

From 45 to 60 Years
+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: April 2004

See protocol details

Summary

Principal SponsorEli Lilly and Company
Last updated: March 9, 2007
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2004Actual date on which the first participant was enrolled.

The purposes of this study are to determine: * The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women. * The effects of arzoxifene on the uterus (womb) in postmenopausal women. * The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density. * The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease risk. * The safety of arzoxifene and any side effects that might be associated with its use.

Official TitleEffects of Arzoxifene on Bone Mineral Density and Endometrial Histology in Postmenopausal Women. 
Principal SponsorEli Lilly and Company
Last updated: March 9, 2007
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
300 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 45 to 60 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Postmenopausal Bone Loss
Criteria
4 inclusion criteria required to participate
Female
45 to 60 years of age, inclusive
At least 2 years since last menstrual cycle
Intact uterus (womb)
4 exclusion criteria prevent from participating
Existing fracture of the spine
Bone disorders, other than low bone mass
History of cancer in the last 5 years. Also, any history, at any time, of breast cancer or cancer of the lining of the uterus
Abnormal or unexplained vaginal bleeding

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.San Diego, United StatesSee the location
CompletedOne Study Center