Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00035997 |
|
Recruitment Status :
Completed
First Posted : May 8, 2002
Last Update Posted : November 23, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
The purpose of this trial with Zometa is to investigate the effect ZOMETA 4 mg (zoledronic acid for injection in 100mg solution ) has in preventing associated bone loss in prostate cancer patients with bone metastasis when administered in conjunction with hormonal cancer therapy. This trial will seek to determine the effect of ZOMETA in stabilizing and increasing bone mineral density in these patients.
This prospective, open-label, single arm, multicenter study will enroll approximately 200 prostate cancer patients with a history of at least one documented bone lesion documented by bone scan or radiograph. Patients must already be receiving hormone therapy and meet the following additional criteria:
- 18 years of age or older
- Histologically confirmed diagnoses of prostate cancer
- Confirmed objective evidence of metastatic bone disease as evidenced by bone scan or radiograph
- Received or will receive hormonal treatment also know as androgen deprivation therapy with an LHRH agonist or other hormonal treatments
Throughout the course of this 12-month trial, patients will be identified based on the duration of established hormonal treatment at the time of enrollment. Each patients duration of participation will be up to 56 weeks including a 4 week screening, 48 week treatment and a 4 week follow up.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer | Drug: Zometa | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 261 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Mineral Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis |
| Study Start Date : | April 2002 |
| Actual Primary Completion Date : | January 2004 |
| Actual Study Completion Date : | January 2004 |
- Changes in bone mineral density of the lumbar spine (L2-L4) at 12 months
- Changes in biochemical markers of bone turnover over 12 months
- Changes in bone mineral density of the total hip at 12 months
- Time to first skeletal-related event
- Overall safety measured by adverse events (AEs)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Signed informed consent
- Age > 18 years
- Histologically confirmed diagnosis of carcinoma of the prostate
- Objective evidence of metastatic disease to the bone as evidenced by bone scan or radiograph at any point since their diagnosis of prostate cancer
- Currently receiving, or will begin receiving, hormonal therapy with an LHRH agonist or other hormonal treatments for either < 6 months or > 6 months
- ECOG performance status of 0, 1, or 2
Exclusion criteria:
- Patients who are hormone sensitive without metastatic disease to the bone
- Patients who are hormone refractory typically defined as two or three consecutive increases in PSA measured at least one month apart while on hormone therapy
- Patients who are not treated with LHRH agonist or other hormonal treatments
- Patients who are currently receiving diethylstilbestrol (DES) or PC-SPES
- Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.
- Patients with abnormal renal function as evidenced by either a serum creatinine greater than 2 mg/dL or by a calculated creatinine clearance of 60 ml/minute or less
- Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035997
Show 56 study locations
| Study Director: | Scott L. Pescatore, PharmD. | Novartis |
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00035997 |
| Other Study ID Numbers: |
CZOL446EUS24 US24 |
| First Posted: | May 8, 2002 Key Record Dates |
| Last Update Posted: | November 23, 2009 |
| Last Verified: | November 2009 |
|
Hormone-sensitive Prostate Cancer Prostate Cancer Bone Metastasis |
|
Prostatic Neoplasms Neoplasm Metastasis Hypersensitivity Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Prostatic Diseases Neoplastic Processes Pathologic Processes Immune System Diseases Zoledronic Acid Bone Density Conservation Agents Physiological Effects of Drugs |