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

NCT00236002 | Terminated Phase 3

• 1 other identifier: ACA-CANA-04-012
• Study Type: interventional
• Target: 182
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Bone mineral density

  ONE YEAR

Secondary Outcomes (1)

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

  every 4 months

Study Arms (1)

placebo

PLACEBO COMPARATOR

Drug: Alendronate

Interventions

Alendronate DRUG

Alendronate 70mgm once a week for one year

Also known as: fosamax

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canadian Urology Research Consortium: lead
• Abbott: collaborator
• Merck Frosst Canada Ltd.: collaborator

MeSH Terms

Conditions

Osteoporosis

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Lesley Carr, M.D.

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 11, 2005
• First Posted: October 12, 2005
• Study Start: July 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: August 1, 2009
• Last Updated: August 12, 2009

Record last verified: 2009-08