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Osteoporosis Prevention in Prostate Cancer Patients Receiving Androgen Ablation Therapy: A Phase III Randomized, Placebo-Controlled, Double-Blind Study

Phase 3
18 Years
Not Enrolling
Osteoporosis, Prostate Cancer

Thank you

Trial Information

Osteoporosis Prevention in Prostate Cancer Patients Receiving Androgen Ablation Therapy: A Phase III Randomized, Placebo-Controlled, Double-Blind Study


- Compare the change in bone mineral density in patients with prostate cancer who are
receiving androgen-ablation therapy treated with calcium and cholecalciferol with or
without conjugated estrogens and with or without risedronate.

- Compare the toxicity of these regimens in these patients.

- Compare the changes in bone markers in patients treated with these regimens.

- Compare the quality of life of patients treated with these regimens.

- Compare hot flashes in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to duration of therapy with luteinizing hormone-releasing hormone
agonists (no more than 30 days vs 31 to 150 days vs 151 to 365 days vs more than 365 days).
Patients are randomized to 1 of 4 treatment arms.

- Arm I: Patients receive oral calcium, oral cholecalciferol, oral risedronate placebo,
and oral estrogen placebo daily.

- Arm II: Patients receive oral calcium, oral cholecalciferol, oral risedronate, and oral
estrogen placebo daily.

- Arm III: Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated
estrogens, and oral risedronate placebo daily.

- Arm IV: Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated
estrogens, and oral risedronate daily.

Treatment in all arms continues for 2 years.

Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.

Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.

PROJECTED ACCRUAL: A total of 282 patients (70 per treatment arm) will be accrued for this
study within 14 months.

Inclusion Criteria


- History of prostate cancer

- No evidence of metastatic bony disease* NOTE: *Elevated prostate-specific
antigen (PSA) allowed

- Meets one of the following criteria:

- Currently on treatment with androgen-ablation therapy in the adjuvant setting

- Rising PSA without other evidence of recurrent disease with planned treatment
for at least 6 months

- No known osteoporosis or prior osteoporotic fracture

- Osteoporosis defined as bone density at the hip or spine of more than 2.5
standard deviations below the mean for young men



- 18 and over

Performance status

- Not specified

Life expectancy

- Not specified


- Not specified


- SGOT or SGPT no greater than 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase normal OR no greater than 1.5 times ULN with a normal bone scan


- Creatinine no greater than 1.5 times ULN

- No prior symptomatic hypercalcemia or hypocalcemia


- No active heart disease

- No congestive heart failure under active treatment

- No myocardial infarction within the past 5 years

- No coronary artery disease (CAD) with recent myocardial infarction

- Patients with a remote history of CAD who are only on medical treatment (e.g.,
antilipid agents) are allowed

- No prior thrombosis (deep vein thrombosis, stroke, or pulmonary embolism) or other
known hypercoagulable state other than cancer


- Fertile patients must use effective contraception

- Triglycerides no greater than 250 mg/dL (treatment allowed)

- Able to complete questionnaire(s) by self or with assistance

- Able to swallow pills

- No prior hyperlipidemia (e.g., prior familial hyperlipidemia or fasting triglyceride
greater than 250 mg/dL within the past 6 months)

- No sarcoidosis

- No parathyroid dysfunction

- No intolerance to bisphosphonates


Biologic therapy

- Not specified


- No concurrent chemotherapy

Endocrine therapy

- See Disease Characteristics

- No concurrent systemic steroids


- No concurrent radiotherapy


- More than 3 months since prior and no concurrent dental extraction, root canal, or
dental implantation


- No prior bisphosphonates

- More than 5 years since prior percutaneous transluminal coronary angioplasty

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Bone mineral density by test at 1 and 2 years

Principal Investigator

Charles L. Loprinzi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

November 2002

Completion Date:

Related Keywords:

  • Osteoporosis
  • Prostate Cancer
  • osteoporosis
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • Osteoporosis
  • Prostatic Neoplasms



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