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CompletedNCT00088010Updated Jun 2, 2010

Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer

A Phase 3 interventional study of Arzoxifene and Placebo in Osteoporosis, Postmenopausal, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to female participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2010-06-02.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
9,369
Allocation
Randomized
Ages
60 Years to 85 Years
Sex
Female
01

Study 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.
02

Conditions studied

  • Osteoporosis, Postmenopausal
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 9,369 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

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

04

Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 60-85 years of age
  • Female
  • At least two years since last menstrual cycle

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
9,369 participants (actual)

Study arms

  • Experimental
    1

    Drug: Arzoxifene

  • Placebo comparator
    2

    Drug: Placebo

Interventions

  • DrugArzoxifene

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

    Also known as: LY353381

  • DrugPlacebo

    oral, tablet, once a day for 36 months

06

What researchers measure

Primary outcomes

  1. Effects of arzoxifene on bone fractures and bone mass

    Time frame: 5 years

  2. Effects of arzoxifene on getting breast cancer

    Time frame: 5 years

  3. The safety of arzoxifene and any side effects

    Time frame: 5 years

Secondary outcomes

  1. Effects of arzoxifene on certain types of cardiovascular events

    Time frame: 5 years

  2. 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

  3. Effects of arzoxifene on the uterus

    Time frame: 5 years

  4. Effects of arzoxifene on cognition

    Time frame: 5 years

  5. Effects of arzoxifene on back pain

    Time frame: 5 years

07

Study locations

1 site
  • 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
08

References and documents

Publications

  • 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. PubMed 23758943 ↗
  • 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. PubMed 22484799 ↗
  • 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. PubMed 21993078 ↗
  • 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. PubMed 20658564 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00088010
Lead sponsor
Eli Lilly and Company
First posted
Jul 20, 2004
Start date
Jun 2004
Primary completion
Jun 2009
Completion
Nov 2009
Last update
Jun 2, 2010

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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