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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00236002
Recruitment Status : Terminated (Slow accrual than anticipated.)
First Posted : October 12, 2005
Last Update Posted : August 12, 2009
Merck Frosst Canada Ltd.
Information provided by:
Canadian Urology Research Consortium

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Alendronate Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : July 2005
Actual Primary Completion Date : November 2007
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: placebo Drug: Alendronate
Alendronate 70mgm once a week for one year
Other Name: fosamax

Primary Outcome Measures :
  1. Bone mineral density [ Time Frame: ONE YEAR ]

Secondary Outcome Measures :
  1. Blood and urine to check liver,kidney,thyroid functions. PSA and bone markers will also be checked [ Time Frame: every 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00236002

Sponsors and Collaborators
Canadian Urology Research Consortium
Merck Frosst Canada Ltd.
Principal Investigator: Lesley Carr, M.D. Sunnybrook Health Sciences Centre

Responsible Party: Dr. Laurence Klotz, Canadian Urology Research Consortium Identifier: NCT00236002     History of Changes
Other Study ID Numbers: ACA-CANA-04-012
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: August 12, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs