Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00181584
• Other study ID #: 03-194
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: July 9, 2013
• Start date: September 2003

Study information

• Verified date: July 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine whether zoledronic acid (Zometa) given once annually increases bone mineral density in men receiving hormone therapy for prostate cancer.

Description:

• Patients will be randomized into 2 groups. At the screening visit, a bone mineral density test will be performed to determine if the patient has osteoporosis or not. Patients with osteoporosis will be treated with Zometa. Patients without osteoporosis will be randomly assigned to receive either Zometa or a placebo.

• Zometa is administered intravenously over a 15 minute prior once in this one year study.

• All patients will asked to take an over-the-counter oral calcium (500mg daily) and a daily multi-vitamin (containing 400-500 I.U of vitamin D) during the study.

• All patients will have clinic visits every 3 months for blood tests and to report any side effects they may be experiencing. At month 12, a bone mineral density test will be repeated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adenocarcinoma of the prostate

• Current androgen deprivation therapy with expected duration of treatment greater than or equal to 12 months

• Corrected serum calcium > 8.4mg/dl and < 10.6mg/dl

• Serum creatinine < 2.0mg/dl

Exclusion Criteria:

• History of bone metastases by bone scan

• Treatment with bisphosphonate within one year

• History of metabolic disease

• Chronic use of glucocorticoids, anticonvulsants, or suppressive doses of thyroxine within one year

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bone Loss
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Zoledronic acid
Given intravenously once.

Other:
• Placebo
Given intravenously once.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare change in bone mineral density from baseline to one year between men treated with Zometa (zoledronic acid) and men treated with placebo.		3 years	No
Secondary	To compare changes in biochemical markers of bone turnover between men treated with zoledronic acid and men treated with placebo		3 years	No
Secondary	to assess the safety and tolerability of zoledronic acid.		3 years	Yes