Zoledronate in Treating Osteopenia or Osteoporosis in Postmenopausal Women Receiving Letrozole for Stage I, Stage II, or Stage IIIA Primary Breast Cancer

NCT00436917 | Completed Results DMC

• 3 other identifiers: MC05C8P30CA0150832330-05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Zoledronate may reduce bone loss in patients receiving letrozole for breast cancer. PURPOSE: This clinical trial is studying how well zoledronate works in treating osteopenia or osteoporosis in postmenopausal women receiving letrozole for stage I, stage II, or stage IIIA primary breast cancer.

Conditions

Breast Cancer; Osteoporosis

Keywords

stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; osteoporosis

Outcome Measures

Primary Outcomes (1)

• Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD)

  Change: BMD values at twelve months post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.

  Baseline and 1 year

Secondary Outcomes (11)

• Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 2 Post Study Entry

  Baseline and 2 year

• Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 3 Post Study Entry

  Baseline and 3 year

• Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 4 Post Study Entry

  Baseline and 4 year

• Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 5 Post Study Entry

  Baseline and 5 year

• Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 1 Post Study Entry

  Baseline and 1 year

Study Arms (1)

zoledronic acid

EXPERIMENTAL

4 mg 15 minutes IV infusion. If creatinine clearance is ≤ 60, dosage should be adjusted as follows:CrCl 50-60: 3.5 mg; CrCl 40-49: 3.3 mg; CrCl 30-39: 3.0 mg.

Drug: zoledronic acid; Procedure: Letrozole as adjuvant therapy

Interventions

zoledronic acid DRUG

zoledronic acid

Also known as: Zometa®

zoledronic acid

Letrozole as adjuvant therapy PROCEDURE

standard care

Also known as: Femara®

zoledronic acid

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of localized breast cancer * Stage I-IIIA disease * Adequately treated breast cancer * No clinical or radiological evidence of recurrent or metastatic disease * Baseline total lumbar spine or femoral neck bone mineral density T-score \< -2.0 standard deviation (e.g., a patient with a T score of -2.1 is eligible) * Hormone-receptor status: * Estrogen receptor and/or progesterone receptor-positive breast cancer PATIENT CHARACTERISTICS: * Female * Postmenopausal, defined by 1 of the following criteria: * Age \> 55 years with cessation of menses * Age ≤ 55 years with spontaneous cessation of menses for \> 1 year * Age ≤ 55 years with spontaneous cessation of menses for ≤ 1 year, but amenorrheic (e.g., spontaneous or secondary to hysterectomy), AND has postmenopausal estradiol levels * Bilateral oophorectomy * ECOG performance status 0-2 * Life expectancy ≥ 5 years * WBC ≥ 3,000/mm³ OR granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Alkaline phosphatase ≤ 3 times upper limit of normal (ULN) * AST ≤ 3 times ULN * Creatinine \< 2.0 mg/dL * Creatinine clearance ≥ 45 mL/min * No hypercalcemia (i.e., calcium level \> 1 mg/dL above ULN) OR hypocalcemia (i.e., calcium level \> 0.5 mg/dL below lower limit of normal) within the past 6 months * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No other nonmalignant systemic diseases, including any of the following: * Uncontrolled infection * Uncontrolled diabetes mellitus * Uncontrolled thyroid dysfunction * Disease affecting bone metabolism (hyperparathyroidism, hypercortisolism, Paget's disease, osteogenesis imperfecta) * Malabsorption syndrome * No uncontrolled seizure disorders associated with falls * No known hypersensitivity to zoledronate or other bisphosphonates, letrozole, calcium, or vitamin D * No concurrent active dental problems, including any of the following: * Infection of the teeth or jawbone (maxillary or mandibular) * Dental or fixture trauma * Prior or current diagnosis of osteonecrosis of the jaw * Exposed bone in the mouth * Slow healing after dental procedures * No contraindication to spine dual energy x-ray absorptiometry (DXA) as defined by any of the following: * History of surgery at the lumbosacral spine, with or without implantable devices * Scoliosis with a Cobb angle \> 15 degrees at the lumbar spine * Immobility, hyperostosis, or sclerotic changes at the lumbar spine, or evidence of sclerotic abdominal aorta sufficient to interfere with DXA scan * Disease of the spine that would preclude the proper acquisition of a lumbar spine DXA * No condition that would preclude study follow-up or compliance * No psychiatric illness that would preclude giving informed consent PRIOR CONCURRENT THERAPY: * More than 3 weeks since prior and no other concurrent oral bisphosphonates * No prior intravenous bisphosphonates * No prior aromatase inhibitor therapy * More than 6 months since prior anabolic steroids or growth hormone * More than 2 weeks since prior and no concurrent inhibitor of osteoclastic bone resorption (e.g., calcitonin, mithramycin, or gallium nitrate) * More than 30 days since prior systemic investigational drug and/or device * More than 7 days since prior topical investigational drug * More than 6 weeks since prior and no concurrent dental or jaw surgery (e.g., extraction, implants) * Concurrent short-term corticosteroid therapy allowed * No concurrent sodium fluoride, parathyroid hormone, or tibolone * No other concurrent investigational drug or device

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Hines SL, Sloan JA, Atherton PJ, Perez EA, Dakhil SR, Johnson DB, Reddy PS, Dalton RJ, Mattar BI, Loprinzi CL. Zoledronic acid for treatment of osteopenia and osteoporosis in women with primary breast cancer undergoing adjuvant aromatase inhibitor therapy. Breast. 2010 Apr;19(2):92-6. doi: 10.1016/j.breast.2009.12.001. Epub 2010 Jan 15.

  PMID: 20079640 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Osteoporosis

Interventions

Zoledronic Acid; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitriles; Triazoles

Results Point of Contact

• Title: Stephanie L. Hines, M.D.
• Organization: Mayo Clinic Jacksonville

hines.stephanie@mayo.edu

507-266-0800

Study Officials

• Stephanie Hines, MD

  Mayo Clinic

  STUDY CHAIR

• Charles L. Loprinzi, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2007
• First Posted: February 19, 2007
• Study Start: April 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: May 9, 2016
• Last Updated: September 11, 2019
• Results First Posted: August 12, 2011

Record last verified: 2016-04

Locations

US (2)