Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00058188
• Date of registration: 07/04/2003
• Primary sponsor: Northwestern University
• Public title: Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation
• Scientific title: A Phase III Randomized Study of Zolendronate Bisphosphonate Therapy for the Prevention of Bone Loss in Men With Prostate Cancer Receiving Long-Term Androgen Deprivation
• Date of first enrolment: March 2003
• Target sample size: 70
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00058188
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Countries of recruitment

United States

Contacts

• Name: Charles L. Bennett, MD, PhD
• Affiliation: Robert H. Lurie Cancer Center

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed prostate cancer

- Stage III or IV disease

- Received at least 3 months of prior androgen deprivation therapy (no maximum
amount/time) by either surgical or medical castration

- Medical castration may be by intermittent or continuous androgen suppression via
single- or combined-drug androgen blockade

- Continued concurrent androgen deprivation therapy required throughout study
participation

- No bone metastases by baseline bone scan

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 1 year

Hematopoietic

- Not specified

Hepatic

- Bilirubin less than 3 times upper limit of normal (ULN)

- AST and ALT less than 3 times ULN

- No chronic liver disease

Renal

- Creatinine no greater than 2.0 mg/dL

Other

- Fertile patients must use effective contraception

- No Paget's disease

- No Cushing's disease

- No hyperthyroidism

- No hyperprolactinemia

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Prior chemotherapy for prostate cancer allowed

Endocrine therapy

- See Disease Characteristics

- More than 12 months since prior suppressive doses of thyroxine or calcitonin

- More than 6 months since prior corticosteroids

- Concurrent corticosteroids allowed (after enrollment on study)

Radiotherapy

- Prior radiotherapy for prostate cancer allowed

Surgery

- See Disease Characteristics

Other

- More than 12 months since prior bisphosphonate therapy (oral or IV)



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Osteoporosis

Prostate Cancer

Intervention(s)

Dietary Supplement: cholecalciferol

Drug: calcium gluconate

Drug: zoledronic acid

Primary Outcome(s)

Bone density change as measured by dual-energy x-ray absorptiometry from baseline to 13 months [Time Frame: Bone scan taken at baseline and month 13]

Secondary Outcome(s)

Incidence of new or progressive bone metastatic disease [Time Frame: Serum osteocalcin and serum bone alkaline phosphatase taken at baseline, month 6 and month 13.]

Incidence of skeletal events (pathologic and non-pathologic bone fractures, spinal cord compression, surgery to bone, and radiotherapy to bone) [Time Frame: PSA taken at baseline, month 3, month 6, month 9, month 12 and month 13. CT scan of abdomen and pelvis taken at baseline and month 13. Serum testosterone, estradiol, parathyroid taken at baseline, month 6 and month 13.]

Markers of bone formation and resorption [Time Frame: Bone alkaline phosphatase taken at baseline, month 6 and month 13.]

Percentage change in lumbar spine and hip bone density as measured by plain film x-rays of lumbar spine and pelvis from baseline to 13 months [Time Frame: Lumbar spine and hip bone density taken at baseline and month 13.]

Secondary ID(s)

NU 02U1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis