Cancer and Osteoporosis Research With Alendronate and Lupron (C.O.R.A.L )

Condition(s) targeted: Osteoporosis

Intervention: Alendronate (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Canadian Urology Research Consortium

Official(s) and/or principal investigator(s):
Lesley Carr, M.D., Principal Investigator, Affiliation: Sunnybrook Health Sciences Centre

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.

Official title: A Phase III, Double-blind, Randomized, Parallel Group, Placebo-controlled Study of Oral Fosamax, 70 mg Once a Week, for the Prevention of Androgen Deprivation Bone Loss in Non-metastatic Prostate Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Bone mineral density

Secondary outcome: Blood and urine to check liver,kidney,thyroid functions. PSA and bone markers will also be checked

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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.

Starting date: July 2005
Last updated: August 11, 2009