Cancer and Osteoporosis Research With Alendronate and Lupron (C.O.R.A.L ) - Full Text View

Sponsors and Collaborators:	Canadian Urology Research Consortium Abbott Merck Frosst Canada Ltd.
Information provided by:	Canadian Urology Research Consortium
ClinicalTrials.gov Identifier:	NCT00236002

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 III

MedlinePlus related topics: Cancer Osteoporosis Prostate Cancer

Drug Information available for: Alendronate Alendronate sodium Leuprolide acetate Leuprolide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Canadian Urology Research Consortium:

Primary Outcome Measures:

Bone marrow Density and xrays [ Time Frame: ONE YEAR ]
Bone marrow density [ Time Frame: ONE YEAR ]

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 ]

Estimated Enrollment:	250
Study Start Date:	July 2005
Study Completion Date:	November 2007

Arms	Assigned Interventions
placebo: Placebo Comparator	Drug: Alendronate Alendronate 70mgm once a week for one year

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

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:

Laurence Klotz

Canadian Urology Research Consortium

More Information

Study ID Numbers:	ACA-CANA-04-012
Study First Received:	October 11, 2005
Last Updated:	November 30, 2007
ClinicalTrials.gov Identifier:	NCT00236002
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Musculoskeletal Diseases
Alendronate
Leuprolide
Osteoporosis

Bone Diseases, Metabolic
Bone Diseases
Prostatic Neoplasms

Additional relevant MeSH terms:

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009