Effect of Androgen Suppression on Bone Loss in Patients With or Without Bone Metastases Secondary to Prostate Cancer

An Evaluation of the Effect of Androgen Ablation on Bone Resorption in Prostate Cancer Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00003903

Enrollment

150

Registered

2003-01-27

Start date

1999-07-31

Completion date

2007-08-31

Last updated

2013-10-16

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

Conditions

Osteoporosis, Prostate Cancer

Keywords

stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, osteoporosis

Brief summary

RATIONALE: Assessing the effect of androgen suppression on bone loss in prostate cancer patients may improve the ability to plan treatment, may decrease the risk of fractures and bony pain, and may help patients live more comfortably. PURPOSE: Clinical trial to determine the effect of androgen suppression on bone loss in patients who have prostate cancer.

Detailed description

OBJECTIVES: * Evaluate the effect of androgen ablation on bone resorption in patients with or without bone metastases secondary to prostate cancer. OUTLINE: Patients are stratified according to prior androgen ablation therapy (yes vs no) and metastatic disease (yes vs no). Patients undergo blood work and 24 hour urine collection on day 1 and at week 6-8. Patients who have received androgen ablation therapy and are found to have increased bone resorption undergo a dual energy x-ray absorptiometry (DEXA) scan. A comparison is made between androgen ablation therapy and bone resorption and if metastases are associated with the two. PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 9 months.

Interventions

PROCEDUREmanagement of therapy complications

Study design

Primary purpose

SUPPORTIVE_CARE

Eligibility

Sex/Gender

MALE

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed prostate cancer * Stratum 1 (androgen ablation therapy): * Bone metastases * Prior orchiectomy allowed * Prior or concurrent leuprolide and/or goserelin therapy allowed * Stratum 2 (androgen ablation therapy): * No bone metastases * Prior orchiectomy allowed * Prior or concurrent leuprolide and/or goserelin therapy allowed * Stratum 3 (no androgen ablation therapy): * No metastatic disease * Prior flutamide or bicalutamide therapy allowed PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Calcium normal Hepatic: * Not specified Renal: * Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics Endocrine therapy: * See Disease Characteristics * No concurrent high dose steroids Radiotherapy: * Prior radiotherapy allowed Surgery: * See Disease Characteristics * Prior radical prostatectomy allowed Other: * No concurrent bisphosphonates

Countries

United States

Outcome results

None listed

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