Clinical trial · Interventional
Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer
Effects of Arzoxifene on Vertebral Fracture Incidence and on Invasive Breast Cancer Incidence in Postmenopausal Women With Osteoporosis or With Low Bone Density.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteoporosis, Postmenopausal | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arzoxifene | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Arzoxifene
- type
- PLACEBO_COMPARATOR
- label
- 2
- interventionNames
- Drug: Placebo
Primary outcomes (3)
- measure
- Effects of arzoxifene on bone fractures and bone mass
- timeFrame
- 5 years
- measure
- Effects of arzoxifene on getting breast cancer
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (4)
- DERIVEDe 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 23758943
- DERIVEDPowles 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 22484799
- DERIVEDGoldstein 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 21993078
- DERIVEDCummings 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 20658564