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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00236002
• Other study ID #: ACA-CANA-04-012
• Status: Terminated
• Phase: Phase 3
• First received: October 11, 2005
• Last updated: August 11, 2009
• Start date: July 2005
• Est. completion date: August 2009

Study information

• Verified date: August 2009
• Source: Canadian Urology Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 182
• Est. completion date: August 2009
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Alendronate
Alendronate 70mgm once a week for one year

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Canadian Urology Research Consortium	Abbott, Merck Frosst Canada Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density		ONE YEAR	No
Secondary	Blood and urine to check liver,kidney,thyroid functions. PSA and bone markers will also be checked		every 4 months	Yes