A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss

Back to results

Primary Purpose

Status

Terminated

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Zoledronic Acid

Placebo

About this trial

This is an interventional treatment trial for Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women focused on measuring Breast Cancer, premenopausal, Bone Mineral density, Cancer therapy induced bone loss, zoledronic acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Female patients with histologically confirmed incident invasive breast cancer (T1-4) with no evidence of regional lymph node metastasis (N0) or distant metastasis (M0) and after complete primary tumor resection and axillary lymph node dissection less than 90 days before start of study drug treatment. Hormone receptor status is negative Patient is premenopausal (spontaneous and regular menses with premenopausal estradiol levels (>10ng/dL) Patient receives adjuvant standard chemotherapy with approved cytotoxic chemotherapeutic drugs (e.g. AC 4-6 cycles) (prior neoadjuvant CT is allowed) Bone density at study entry > -2.5 T-Score Exclusion Criteria: Prior treatment with bisphosphonates and estrogens or treatments for osteoporosis in addition to calcium and vitamin D Severe physical or psychological concomitant diseases and other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future (e.g., myocardial infarction in previous six months, angina pectoris despite treatment, uncontrolled severe arterial hypertension, progressive cardiac or respiratory failure) Known hypersensitivity to bisphosphonates Abnormal renal function Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); 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 and recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)

Sites / Locations

Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zoledronic Acid

Placebo

Arm Description

Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.

Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.

Outcomes

Primary Outcome Measures

Change in Bone Mineral Density (BMD) Measured by DXA at Lumbar Spine (L2-L4) Between Baseline and 24 Months.

Secondary Outcome Measures

Bone Mineral Density (BMD) Measured by QUS at os Calcis and Phalanges After 24 Months

Course of Biochemical Markers of Bone Turn Over (FSH, Estradiol (E2), Osteocalcin, PINP, Procollagene-I-peptid, Deoxypyridinoline in Serum)

Pathologic Fractures During 24 Month

Development of Metastases as Assessed by X-ray, CT, or MRI During 24 Months and During 60 Months

Full Information

NCT ID

NCT00333229

First Posted

May 31, 2006

Last Updated

November 17, 2014

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00333229

Brief Title

A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss

Official Title

Influence of Zoledronic Acid on Bone Mineral Density and Bone Ultrasonometry in Premenopausal Women With Hormone Receptor Negative Breast Cancer and Adjuvant Chemotherapeutic Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Terminated

Why Stopped

Due to rare patient population, planned number of patients could not be recruited in a reasonable timeframe. Recruitment was stopped prematurely.

Study Start Date

March 2006 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

Breast cancer and osteoporosis are two of the most frequent diseases in women. Estrogen may be associated with bone loss and the risk of breast cancer because of its potent effects on the mitotic activity of breast epithelium and on bone turnover. This study is will assess the safety and efficacy of Zoledronic acid 4 mg, given every 3 months over 24 months, in improving bone mineral density in premenopausal women with hormone receptor negative breast cancer and adjuvant chemotherapeutic treatment compared to placebo. This study is not recruiting patients in the United States.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women

Keywords

Breast Cancer, premenopausal, Bone Mineral density, Cancer therapy induced bone loss, zoledronic acid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Non-Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zoledronic Acid

Arm Type

Experimental

Arm Description

Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.

Intervention Type

Drug

Intervention Name(s)

Zoledronic Acid

Intervention Description

4 mg zoledronic acid in 5 mL concentrate solution. Plastic vials.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching Placebo

Primary Outcome Measure Information:

Title

Change in Bone Mineral Density (BMD) Measured by DXA at Lumbar Spine (L2-L4) Between Baseline and 24 Months.

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Bone Mineral Density (BMD) Measured by QUS at os Calcis and Phalanges After 24 Months

Time Frame

2 years

Title

Course of Biochemical Markers of Bone Turn Over (FSH, Estradiol (E2), Osteocalcin, PINP, Procollagene-I-peptid, Deoxypyridinoline in Serum)

Time Frame

2 years

Title

Pathologic Fractures During 24 Month

Time Frame

2 years

Title

Development of Metastases as Assessed by X-ray, CT, or MRI During 24 Months and During 60 Months

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Female patients with histologically confirmed incident invasive breast cancer (T1-4) with no evidence of regional lymph node metastasis (N0) or distant metastasis (M0) and after complete primary tumor resection and axillary lymph node dissection less than 90 days before start of study drug treatment. Hormone receptor status is negative Patient is premenopausal (spontaneous and regular menses with premenopausal estradiol levels (>10ng/dL) Patient receives adjuvant standard chemotherapy with approved cytotoxic chemotherapeutic drugs (e.g. AC 4-6 cycles) (prior neoadjuvant CT is allowed) Bone density at study entry > -2.5 T-Score Exclusion Criteria: Prior treatment with bisphosphonates and estrogens or treatments for osteoporosis in addition to calcium and vitamin D Severe physical or psychological concomitant diseases and other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future (e.g., myocardial infarction in previous six months, angina pectoris despite treatment, uncontrolled severe arterial hypertension, progressive cardiac or respiratory failure) Known hypersensitivity to bisphosphonates Abnormal renal function Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); 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 and recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmeceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35043

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://www.novartisclinicaltrials.com/etrials/searchTrial.do?trialID=717

Description

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial