Clinical trial NCT00088010: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2004-07-20
Enrollment: 9369
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Effects of arzoxifene on bone fractures and bone mass
timeFrame: 5 years
measure: Effects of arzoxifene on getting breast cancer
timeFrame: 5 years
measure: The safety of arzoxifene and any side effects
timeFrame: 5 years
Secondary outcomes:
measure: Effects of arzoxifene on certain types of cardiovascular events
timeFrame: 5 years
measure: Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health
timeFrame: 5 years
measure: Effects of arzoxifene on the uterus
timeFrame: 5 years
measure: Effects of arzoxifene on cognition
timeFrame: 5 years
measure: Effects of arzoxifene on back pain
timeFrame: 5 years
Other outcomes:
Locations:
city: Elk Grove
country: United States
facility: 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.
state: Illinois
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.