Bone Health Observational Study (BHOS)

CMX Research

Status: Completed

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00632905

AZ-CMX-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 599 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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.

Trial design

599 participants in 3 patient groups

1

Description:

Normal - BMD with T-score at or above -1.0

2

Description:

Osteopenic - BMD with T-score between -1.1 and -2.4

3

Description:

Osteoporotic - BMD with T-score at or below -2.5