An Open label Randomised, multicentre study to evaluate the efficacy of two Zometa (Zoledronic acid) schedules on bone mineral density in prostrate cancer patients undergoing Androgen deprivation Therapy (ADT)

Phase 1

• Conditions: Decreased bone mineral density in prostate cancer patients being treated with ADT

• Registration Number: EUCTR2005-004765-42-GB
• Lead Sponsor: ovartis Pharmaceuticals UK Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-03-17
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 300

Inclusion Criteria

• Signed informed consent
•Age > 18 years
•Histologically confirmed diagnosis of carcinoma of the prostate
•No distant metastases (stage Tany Nany MO)
•Patients must be candidates for the initiation of androgen deprivation therapy (ADT)
•Patient with a baseline BMD T-score at or below -1 standard deviations in the lumbar spine (L2-L4) are eligible
•Life expectancy of at least 12 months
•ECOG performance status of 0, 1, or 2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patients with normal BMD at trial entry
•Patients who received any prior bisphosphonate therapy in the past 12 months
•Patients who have received previous treatment with LHRH agonists or have undergone an orchidectomy more than 1 month before visit 1.
•Treatment with anti-androgen mono- or combination therapy. (However, patients can receive a maximum of 6 weeks total anti-androgen therapy to control flare).
•Patients who are currently receiving diethylstilbesterol (DES) or who have previously received PC-SPES
•Patients who have received prior treatment with systemic corticosteroids within the past 12 months (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting or for acute illness like asthma exacerbation, is acceptable)
•Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months
•Patients with any prior treatment for osteoporosis
•Patients with previous or concomitant malignancy within the past 5 years except adequately treated basal or squamous cell carcinoma of the skin, and colonic polyps with non-invasive malignancy which have been removed
•Patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol, including:
-uncontrolled infections
-uncontrolled type 2 diabetes mellitus
-diseases with influence on bone metabolism, such as Paget’s disease or uncontrolled thyroid or parathyroid dysfunction
-cardiovascular, renal, hepatic, pulmonary and neurologic/psychiatric diseases which would prevent prolonged follow-up
•History of surgery at the lumbosacral spine, with or without implantable devices, bilateral hip replacement or bilateral hip surgery with implantation of an appliance.
.Any condition that prevents the patients from having a DEXA scan (eg deformities of the spine).
•Patients treated with systemic investigational drugs(s) and /or device(s) within the past 30 days
•Abnormal renal function as evidenced by a calculated creatinine clearance <30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula
•Current active dental problems including infection of the teeth or jawbone (maxilla or mandible); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
•Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)
•Known hypersensitivity to Zometa® (zoledronic acid) or other bisphosphonates
•Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study
•Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
•History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified