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

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.

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Key information

Conditions

Cancer Prostate Bone Diseases Bone Diseases, Metabolic Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Metabolic Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Osteoporosis Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Anderlecht, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria may apply.

Treatment and study plan

Zoledronic acid

Drug

Primary outcomes

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.

Time frame: at 6 months

Secondary outcomes

If and to what extent rising levels of PSA can be used as an indicator for the development of bone metastases

Time frame: at 6 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start: 2004
Primary completion: 2009
Study completion: 2009
First posted: Sep 15, 2005
Registry last updated: Mar 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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