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

Canadian Urology Research Consortium

Status and phase

Terminated

Phase 3

Conditions

Osteoporosis

Treatments

Drug: Alendronate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00236002

ACA-CANA-04-012

Details and patient eligibility

About

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.

Full 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.

Enrollment

182 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.