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Study to Assess Efficacy and Safety of Zoledronic Acid and the Value of Markers of Bone Resorption in the Prediction of Bone Metastases and Cancer Treatment-induced Bone Loss (CTIBL) in Patients With Prostate Cancer on Hormone Therapy

Study to Assess Efficacy and Safety of Zoledronic Acid and the Value of Markers of Bone Resorption in the Prediction of Bone Metastases and Cancer Treatment-induced Bone Loss (CTIBL) in Patients With Prostate Cancer on Hormone Therapy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00172055
Enrollment
218
Registered
2005-09-15
Start date
2004-12-31
Completion date
2009-07-31
Last updated
2017-03-06

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

Conditions

Cancer Prostate

Keywords

Zoledronic acid, Zometa, prostate cancer, osteoporosis

Brief summary

The objective of the study is to investigate whether blood markers can be used to predict the development of bone metastases and to assess the efficacy and safety of zoledronic acid in cancer treatment induced bone loss.

Interventions

DRUGZoledronic acid

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All stages of prostate cancer without bone metastases * No evidence of severe osteoporosis * ECOG performance status 0, 1 or 2

Exclusion criteria

* Surgery / fracture at the lumbosacral spine, bilateral hip implants * Evidence of metabolic bone diseases, * Treatment with bisphosphonates or calcitonin within the previous year or chronic systemic corticosteroid treatment * Abnormal kidney or liver function * Other cancers within the last 5 years Other protocol-defined

Design outcomes

Primary

MeasureTime frame
If and to what extent rising levels of the bone resorption marker CTX can be used as an indicator for the development of bone metastases, diagnosed via bone scintigraphy.at 6 months

Secondary

MeasureTime frame
If and to what extent rising levels of PSA can be used as an indicator for the development of bone metastasesat 6 months

Countries

Belgium

Outcome results

None listed

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