Bone Mineral Density Effects of Zoledronate in Postmenopausal Women With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Bone Mineral Density Effects of Zoledronate in Postmenopausal Women With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213980
• Other study ID #: CO99103
• Secondary ID: A534260SMPH/MEDI
• Status: Completed
• Phase: Phase 2
• Start date: January 2000
• Est. completion date: April 2008

Study information

• Verified date: December 2017
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a two arm, double-blind randomized study looking at the effect of zoledronate, a bisphosphonate, on the bone mineral density (BMD) of postmenopausal women with breast cancer.

Description:

This is a two arm, double-blind randomized study looking at the effect of zoledronate, a bisphosphonate, on the bone mineral density (BMD) of postmenopausal women with breast cancer. An approved bisphosphonate, alendronate, is of benefit in patients with osteoporosis, however, this agent has a roughly 30% incidence of gastrointestinal symptoms and up to 50% of patients may take the drug improperly, compromising absorption and potentially efficacy. Zoledronate is a heterocyclic imidazole third generation bisphosphonate, which is administered intravenously (IV) and has little toxicity. Zoledronate is more potent than alendronate, and because of its route of administration it does not have the problems of poor oral bioavailability and non-compliance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Postmenopausal women, Stage III or axillary node positive

• Currently disease free of breast cancer and other invasive malignancies at the time of registration

• No concurrent use of bisphosphonates

Exclusion Criteria:

• Metastatic disease

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Zoledronate
4 mg IV over 15 minutes administered once every 12 weeks times 4

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Bone Mineral Density (BMD) From Baseline to 1 Year	To determine whether zoledronate 4 mg IV every 12 weeks x 4 doses is associated with increases in bone mineral density at the lumbar spine and femoral head, calculated from baseline and 1 year data. Participants who missed one or more DXA were not evaluated.	Up to 1 year
Secondary	Rates of Metastases	Determine whether zoledronate is associated in rates of bone, visceral, and all distant metastases.	Up to 1 year
Secondary	Overall Survival	Number of participants who survived from the start of treatment through off treatment, up to 10 years.	Up to 10 years
Secondary	Clinical Toxicity of ZA	Tolerability and side effects of ZA, measured by the number of participants experiencing adverse events.	Up to 1 year

External Links

•   University of Wisconsin Carbone Cancer Center