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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00181584

Enrollment

Registered

2005-09-16

Start date

2003-09-30

Completion date

Unknown

Last updated

2013-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Loss, Prostate Cancer

Keywords

Androgen deprivation therapy, bone loss, prostate cancer, Zoledronic Acid, Zometa

Brief 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.

Detailed 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.

Interventions

DRUGZoledronic acid

Given intravenously once.

OTHERPlacebo

Given intravenously once.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
To compare changes in biochemical markers of bone turnover between men treated with zoledronic acid and men treated with placebo	3 years
to assess the safety and tolerability of zoledronic acid.	3 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026