Skip to main content
OpenTrials
Completed

NCT Number: NCT00632905

Bone Health Observational Study

Prostate Cancer patients treated with LHRH agonists (e.g., goserelin) lose Bone Mineral Density (BMD). Using a prospective, observational study design, we propose that monitoring how physicians manage Cancer Treatment Induced Bone Loss(CTIBL) in their patients. The gold standard for evaluating BMD is dual energy x-ray absorptiometry (DEXA). The proposed study will provide some of the first prospective data on the rates of Skeletal Related Events (SREs) in prostate cancer patients undergoing ADT and help develop official guidelines on the use of DEXA screening for prostate cancer patients.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Dr. John A. Warner, Burnaby, British Columbia, Canada

Loading trial locations.

About this study

A consequence of ADT is the gradual bone loss, so-called cancer treatment induced bone loss (CTIBL). The current standard of care is the addition of Vitamin D and Calcium upon the initiation of ADT. Moreover, bisphosphonates are now being considered to treat and prevent CTIBL. However, bisphosphonates are costly, thus there is a desire to identify or target a specific subset of patients who would most benefit from the treatment.

By obtaining baseline BMD and monitoring for Skeletal Related Events (SREs), we hope to identify that specific sub-set of patients who would most benefit from the treatment. Using a prospective, observational study design, we propose monitoring how physicians manage CTIBL in their patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients willing to provide written Informed Consent.
  • Patients for whom Androgen Deprivation Therapy (ADT) with Zoladex® is indicated for at least 1 year.
  • Patients started on Zoladex® within the last 4 months.

Exclusion criteria

  • Patient had surgery or significant traumatic injury occurring within 1 month prior to consent.
  • Known hypersensitivity to Goserelin Acetate or any of the components found in Zoladex®.
  • Any concurrent condition that would make it undesirable, in the physician's opinion, for the subject to participate in the study or would jeopardize compliance with the protocol.

Treatment and study plan

Primary outcomes

  1. Bone Mineral Density of the lumbar spine

    Time frame: 12 months

Secondary outcomes

  1. Overall Safety

    Time frame: 12 Months

Sponsors and collaborators

Lead sponsor

CMX Research

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

A Prospective Study to Evaluate the Incidence of Skeletal Related Events In Prostate Cancer Patients Undergoing Androgen Deprivation Therapy (ADT).

Acronym: BHOS

Important dates

Study start
2007
Primary completion
2016
Study completion
2016
First posted
Mar 11, 2008
Registry last updated
Sep 28, 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.

Published trials that share one or more normalized conditions with this study.