NCT00088010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,369

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2004

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2004

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

June 2, 2010

Status Verified

May 1, 2010

Enrollment Period

5 years

First QC Date

July 19, 2004

Last Update Submit

May 27, 2010

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (3)

  • Effects of arzoxifene on bone fractures and bone mass

    5 years

  • Effects of arzoxifene on getting breast cancer

    5 years

  • The safety of arzoxifene and any side effects

    5 years

Secondary Outcomes (5)

  • Effects of arzoxifene on certain types of cardiovascular events

    5 years

  • Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health

    5 years

  • Effects of arzoxifene on the uterus

    5 years

  • Effects of arzoxifene on cognition

    5 years

  • Effects of arzoxifene on back pain

    5 years

Study Arms (2)

1

EXPERIMENTAL
Drug: Arzoxifene

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ArzoxifeneDRUG

20mg, oral, tablet, once a day for 36 months

Also known as: LY353381
1
PlaceboDRUG

oral, tablet, once a day for 36 months

2

Eligibility Criteria

Age60 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Female
  • At least two years since last menstrual cycle

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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.

Elk Grove, Illinois, 60007, United States

Location

Related Publications (4)

  • 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.

    PMID: 23758943DERIVED

  • 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.

    PMID: 22484799DERIVED

  • 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.

    PMID: 21993078DERIVED

  • 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.

    PMID: 20658564DERIVED

Related Links

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

LY 353381

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 19, 2004

First Posted

July 20, 2004

Study Start

June 1, 2004

Primary Completion

June 1, 2009

Study Completion

November 1, 2009

Last Updated

June 2, 2010

Record last verified: 2010-05

Locations

US(1)