Bone Health Observational Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00632905

Acronym

BHOS

Enrollment

599

Registered

2008-03-11

Start date

2007-09-30

Completion date

2016-03-31

Last updated

2017-09-28

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

Conditions

Prostate Cancer

Keywords

Prostate Cancer, Prostatic adenoma, Prostatic neoplasm

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Bone Mineral Density of the lumbar spine	12 months

Secondary

Measure	Time frame
Overall Safety	12 Months

Countries

Canada

Outcome results