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

This study has been terminated.
(Slow accrual than anticipated.)
Sponsor:
Collaborators:
Abbott
Merck Frosst Canada Ltd.
Information provided by:
Canadian Urology Research Consortium
ClinicalTrials.gov Identifier:
NCT00236002
First received: October 11, 2005
Last updated: August 11, 2009
Last verified: August 2009
  Purpose

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 Intervention Phase
Osteoporosis
Drug: Alendronate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Canadian Urology Research Consortium:

Primary Outcome Measures:
  • Bone mineral density [ Time Frame: ONE YEAR ] [ Designated as safety issue: No ]

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

Enrollment: 182
Study Start Date: July 2005
Study Completion Date: August 2009
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: Alendronate
Alendronate 70mgm once a week for one year
Other Name: fosamax

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236002

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

No publications provided

Responsible Party: Dr. Laurence Klotz, Canadian Urology Research Consortium
ClinicalTrials.gov Identifier: NCT00236002     History of Changes
Other Study ID Numbers: ACA-CANA-04-012
Study First Received: October 11, 2005
Last Updated: August 11, 2009
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on July 24, 2014