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Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer

Primary Purpose

Osteoporosis, Postmenopausal

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Arzoxifene
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis, Postmenopausal

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 60-85 years of age Female At least two years since last menstrual cycle Exclusion Criteria: Abnormal or unexplained vaginal bleeding. Bone disorders, other than osteoporosis or low bone mass History of breast cancer, cancer of the uterus, or any cancer in the last five years (except skin cancer). History of cerebral vascular accidents or venous thromboembolic events Medications outlined

Sites / Locations

  • 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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Effects of arzoxifene on bone fractures and bone mass
Effects of arzoxifene on getting breast cancer
The safety of arzoxifene and any side effects

Secondary Outcome Measures

Effects of arzoxifene on certain types of cardiovascular events
Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health
Effects of arzoxifene on the uterus
Effects of arzoxifene on cognition
Effects of arzoxifene on back pain

Full Information

First Posted
July 19, 2004
Last Updated
May 27, 2010
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00088010
Brief Title
Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer
Official Title
Effects of Arzoxifene on Vertebral Fracture Incidence and on Invasive Breast Cancer Incidence in Postmenopausal Women With Osteoporosis or With Low Bone Density.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this trial is to study: Effects of arzoxifene on bone fractures and bone mass. Effects of arzoxifene on getting breast cancer. Effects of arzoxifene on certain types of cardiovascular events, such as heart attack and stroke. Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health. Effects of arzoxifene on the uterus. The safety of arzoxifene and any side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9369 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Arzoxifene
Other Intervention Name(s)
LY353381
Intervention Description
20mg, oral, tablet, once a day for 36 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral, tablet, once a day for 36 months
Primary Outcome Measure Information:
Title
Effects of arzoxifene on bone fractures and bone mass
Time Frame
5 years
Title
Effects of arzoxifene on getting breast cancer
Time Frame
5 years
Title
The safety of arzoxifene and any side effects
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Effects of arzoxifene on certain types of cardiovascular events
Time Frame
5 years
Title
Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health
Time Frame
5 years
Title
Effects of arzoxifene on the uterus
Time Frame
5 years
Title
Effects of arzoxifene on cognition
Time Frame
5 years
Title
Effects of arzoxifene on back pain
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 60-85 years of age Female At least two years since last menstrual cycle Exclusion Criteria: Abnormal or unexplained vaginal bleeding. Bone disorders, other than osteoporosis or low bone mass History of breast cancer, cancer of the uterus, or any cancer in the last five years (except skin cancer). History of cerebral vascular accidents or venous thromboembolic events Medications outlined
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Elk Grove
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23758943
Citation
e Silva AV, Lacativa PG, Russo LA, de Gregorio LH, Pinheiro RA, Marinheiro LP. Association of back pain with hypovitaminosis D in postmenopausal women with low bone mass. BMC Musculoskelet Disord. 2013 Jun 12;14:184. doi: 10.1186/1471-2474-14-184.
Results Reference
derived
PubMed Identifier
22484799
Citation
Powles TJ, Diem SJ, Fabian CJ, Neven P, Wickerham DL, Cox DA, Muram D, Agnusdei D, Dowsett SA, Amewou-Atisso M, Cummings SR. Breast cancer incidence in postmenopausal women with osteoporosis or low bone mass using arzoxifene. Breast Cancer Res Treat. 2012 Jul;134(1):299-306. doi: 10.1007/s10549-012-2041-5. Epub 2012 Apr 8.
Results Reference
derived
PubMed Identifier
21993078
Citation
Goldstein SR, Bhattoa HP, Neven P, Cox DA, Dowsett SA, Alam J, Sipos A, Muram D. Gynecologic effects of arzoxifene in postmenopausal women with osteoporosis or low bone mass. Menopause. 2012 Jan;19(1):41-7. doi: 10.1097/gme.0b013e318223bbf4.
Results Reference
derived
PubMed Identifier
20658564
Citation
Cummings SR, McClung M, Reginster JY, Cox D, Mitlak B, Stock J, Amewou-Atisso M, Powles T, Miller P, Zanchetta J, Christiansen C. Arzoxifene for prevention of fractures and invasive breast cancer in postmenopausal women. J Bone Miner Res. 2011 Feb;26(2):397-404. doi: 10.1002/jbmr.191. Epub 2010 Jul 23.
Results Reference
derived

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Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer

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