Cancer and Osteoporosis Research With Alendronate and Lupron (C.O.R.A.L )
Cancer and Osteoporosis Research With Alendronate and Lupron (C.O.R.A.L )
Multi-center,double blind randomized phase III placebo controlled study in 250 men with
 histologically proven prostate cancer with out bone metastases who are beginning ADT therapy
 and who will receive concomitant treatment with either oral Fosamax 70mg once weekly or
 placebo for one year.These men will be treated and follow up for one year,during which time
 changes in BMD, markers of bone resorption and formation will be monitored.All patients will
 receive calcium and vitamin D through out the study.
This is a phase three multicentre, double blind, randomize parallel group, placebo-controlled
 study in 250 men with histologically proven cancer without bone metastases who are beginning
 ADT therapy and who will receive a concomitant treatment with either oral Fosamax 70 mg once
 a weak (n=125) or placebo (n=125) for one year. Changes in BMD, markers of bone absorption
 and formation are monitored.
Inclusion Criteria:

 -  Histologically/cytologically proven, non-metastatic (M0) adenocarcinoma of the
 prostate.

 -  Life expectancy of > 12 months.

 -  Initiation of treatment with the luteinizing hormone-releasing hormone agonist
 (LHRH-a) Lupron no more than 15 days prior or 30 days following, baseline visit.

 -  Requiring treatment with LHRH agonists for prostate cancer, for a duration of at least
 12 months from baseline.

 -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

 -  Prior to any study-specific procedures, subject (and/or their legally authorized
 representative) has voluntarily signed and dated an informed consent form.

 Exclusion Criteria:

 Bone Metastases Current or previous use with in past 12 months of bisphosphonate. Known
 hypersensitivity to LHRH. Hypocalcaemia. Severe renal impairment, Abnormal liver function,
 Hypothyroidism, Hyperthyroidism, Bilateral hip replacement.

 Use of LHRH or anti-androgen medication within last 12 months. Abnormalities of esophagus
 which delay esophageal emptying. Inability to stand or sit upright for at least 30 minutes.