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A Phase III Randomized Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer

Phase 3
18 Years
Open (Enrolling)
Osteoporosis, Prostate Cancer

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Trial Information

A Phase III Randomized Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer



- Compare the potential benefit of bisphosphonate therapy comprising zoledronate plus
vitamin D and calcium supplement vs standard therapy with vitamin D and calcium
supplement in the prevention of osteoporosis and associated bone fractures in patients
with locally advanced nonmetastatic adenocarcinoma of the prostate undergoing
radiotherapy and luteinizing hormone-releasing hormone (LHRH) agonist therapy.


- Evaluate the potential benefit of these regimens on quality of life in these patients.

- Evaluate the potential benefit in bone mineral density over a period of 3 years for
patients treated with these regimens.

OUTLINE: This is randomized multicenter study. Patients are stratified according to T score
of the hip by dual x-ray absorptiometry (DXA) scan (< -1.0 but > -2.5 vs ≥ - 1.0) and
planned duration of luteinizing hormone-releasing hormone (LHRH) agonist therapy (1-2½ years
vs > 2½ years). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Parents receive zoledronate IV over 15 minutes once every 6 months. Patients
also receive oral calcium and oral cholecaliciferol (vitamin D) once daily. Treatment
continues for 3 years in the absence of bone fractures, disease progression, or
unacceptable toxicity.

- Arm II: Patients receive oral calcium and oral vitamin D once daily. Treatment
continues for 3 years in the absence of bone fractures, disease progression, or
unacceptable toxicity.

All patients also undergo concurrent radiotherapy (external beam, brachytherapy, or both)
and LHRH agonist (e.g., leuoprolide acetate, goserelin, buserelin, or triptorelin) therapy.

Quality of life is assessed at baseline and every 6 months during treatment.

PROJECTED ACCRUAL: A total of 1,272 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed adenocarcinoma of the prostate

- Diagnosed within the past 12 months

- Any 1 of the following clinical stages:

- Clinical stage T3, any N, M0 with any Gleason score and any prostate-specific
antigen (PSA)

- Any T, any N, M0 with one of the following:

- Gleason score ≥ 8 and any PSA

- Gleason score 7 and PSA ≥ 15 ng/mL

- Gleason score < 7 and PSA ≥ 20 ng/mL

- Baseline T score > -2.5 in both the L spine and the total hip by dual x-ray
absorptiometry (DXA) scan

- Planning to receive luteinizing hormone-releasing hormone (LHRH) agonist therapy

- If patient is receiving LHRH therapy before study entry, therapy must have begun
≤ 6 months prior to study entry

- Scheduled to receive a LHRH agonist for ≥ 1 year

- Planning to undergo radiotherapy (i.e., external-beam, brachytherapy, or both)

- No distant metastases

- Must have negative bone scan for metastatic disease


- Zubrod performance status 0-1

- Creatinine clearance > 30 mL/min

- Calcium 8.4-10.6 mg/dL

- Fertile patients must use effective contraception during and for ≥ 3 months after
completion of study treatment

- No history of Paget's disease

- No uncontrolled thyroid or parathyroid dysfunction

- No known hypersensitivity to zoledronate or other bisphosphonates

- No infection of the teeth or jawbone

- No dental or fixture trauma

- No current or prior diagnosis of osteonecrosis of the jaw

- No exposed bone in the mouth

- No slow healing after dental procedures

- No other active dental problems

- No other diseases that influence bone metabolism

- No other malignancy within the past 3 years except nonmelanomatous skin cancer or
carcinoma in situ of the breast or oral cavity


- See Disease Characterisitics

- More than 6 weeks since prior dental or jaw surgery (e.g., extraction, implants)

- No prior bisphosphonate therapy

- No prior pelvic radiation

- No prior systemic radiotherapeutic agents, such as strontium chloride Sr 89 or
samarium Sm 153 lexidronam pentasodium

- No concurrent systemic chemotherapy

- No concurrent steroids

- No concurrent growth hormones

- No concurrent calcitonin

- No concurrent dental or jaw surgery

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Freedom from any bone fracture

Safety Issue:


Principal Investigator

Colleen A. Lawton, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical College of Wisconsin


United States: Federal Government

Study ID:




Start Date:

March 2006

Completion Date:

Related Keywords:

  • Osteoporosis
  • Prostate Cancer
  • osteoporosis
  • adenocarcinoma of the prostate
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Osteoporosis
  • Prostatic Neoplasms



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