Clinical trial NCT00236002: Cancer and Osteoporosis Research With Alendronate and Lupron (C.O.R.A.L )
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Osteoporosis
Lead sponsor: Canadian Urology Research Consortium
Sponsor class: OTHER
Collaborators: name: Abbott
name: Merck Frosst Canada Ltd.
First posted: 2005-10-12
Enrollment: 182
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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.

Primary outcomes:
measure: Bone mineral density
timeFrame: ONE YEAR
Secondary outcomes:
measure: Blood and urine to check liver,kidney,thyroid functions. PSA and bone markers will also be checked
timeFrame: every 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Lesley Carr, M.D.
role: PRINCIPAL_INVESTIGATOR
References: