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Study of Bone Mineral Density in Postmenopausal Women After Treatment for Breast Cancer | Clinical Trials | Clareo Health

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Study of Bone Mineral Density in Postmenopausal Women After Treatment for Breast Cancer

A Pilot Study of Bone Mineral Density in Postmenopausal Women After Treatment for Breast Cancer

NCT00587925•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

Bone Mineral Density (BMD) as measured by X-ray shows the amount of calcium in the bone. Low BMD may reflect osteoporosis, a condition where there is an increased risk of fracture. Women who have gone through menopause have a higher risk of getting osteoporosis because they lose calcium from their bones much faster than younger women. Women with breast cancer may have an additional risk for getting osteoporosis because of the effects of their treatment with chemotherapy. The purpose of this study is to see what levels of BMD post-menopausal women with breast cancer have, and to see if the level of BMD changes during a women's treatment after her surgery. This trial studies changes in BMD and markers of bone activity in women receiving treatment for early stage breast cancer.

Detailed Description

Breast cancer patients may be at increased risk for osteoporosis secondary to cancer treatment. The hypothesis of this study is that adjuvant chemotherapy increases the risk of osteoporosis in postmenopausal women. The objective of this pilot study is to describe the effects of chemotherapy on bone mineral density and serum markers of bone metabolism. There is limited data on the change in bone mineral density due to chemotherapy in postmenopausal women. This prospective study will gather data on the effects of systemic breast cancer therapy on bone mineral density in postmenopausal women receiving adjuvant care for early stage (0, I, II or III) breast cancer. Postmenopausal women are the focus of this study because: (1) they are the largest subgroup of women with breast cancer (2) they are expected to have a rate of BMD loss unless disturbed by disease or medications, unlike the pre and perimenopausal women whose BMD is dramatically affected by changes in hormonal status (3) this group of patients is at greatest risk for acute osteoporotic fractures.

Eligibility

Age

All ages

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Documented histologically or cytologically proven diagnosis of breast cancer
•Non-metastatic breast cancer tumor with the diagnosis of Tis, T1-T4, N0-3, M0 (Stage 0, I, II or III breast cancer) by the American Joint Committee on Cancer revised tumor-nodal-metastases staging system (Singletary, JCO 2002). DCIS is allowed, but LCIS (only) is not. Adjuvant care is administered as clinically indicated. Adjuvant treatment decisions are not stipulated in this trial.
•Postmenopausal as defined by last menstrual cycle occurring more than 5 years previously. Women who have had a hysterectomy without bilateral oophorectomy will be considered postmenopausal if greater than 55 years of age. Women who have had a bilateral oophorectomy more than 5 years previously will be considered postmenopausal.
•Chemotherapy Arm: Patients about to begin adjuvant, or neoadjuvant, treatment with Doxorubicin (60mg/m2), Cyclophosphamide (600mg/m2) followed by Paclitaxel (175mg/m2) (AC-T) or Doxorubicin (60mg/m2) for 4 cycles followed by Paclitaxel (175mg/m2) for 4 cycles followed by Cyclophosphamide (600mg/m2) for 4 cycles (A-T-C) administered in the dose dense regimen every 2 weeks with growth
•factor support. The patient may enter this trial within 3 months of initiating adjuvant chemotherapy.
•Observation Arm: Patients begin adjuvant follow up with expectant monitoring (no systemic therapy). The patient may enter this trial within 2 months of initiating adjuvant care.
•Signed informed consent
•Assessment of the complete blood count and complete biochemical profile must indicate absolute neutrophil count \>1000/ul, hemoglobin \> 9 g/dl and platelets \>100,000/ul and the bilirubin, liver transaminases (AST/ALT) and serum creatinine must be within 2.5 times the institutional upper level of normal at the time of enrollment into the study.

Exclusion Criteria

•Any metabolic bone disease (including Paget's disease of the bone) other than postmenopausal osteoporosis or osteopenia.
•Use of systemic gonadal hormonal medications or supplements within the past 24 months. Topical vaginal estrogens such as "Estring" or other vaginal estrogenic compounds not associated with systemic absorption are allowed.
•Prior use of tamoxifen or raloxifene is permitted if the medication was discontinued more then 24 months prior to the diagnosis of breast cancer. No adjuvant antiestrogen, antineoplastic, therapies are permitted on study.
•Chronic use of systemic steroids (equivalent of prednisone 5mg daily for more then 3 months) for disease process other than breast cancer chemotherapy premedications or antiemetics. Inhaled steroids are allowed, as is the occasional use of low to moderate dose short pulse steroids.
•History of rheumatoid arthritis, ankylosing spondylitis, hyperparathyroidism, renal osteodystrophy, moderate to severe inflammatory or autoimmune diseases or newly diagnosed thyroid condition requiring titration of medications (stable dose and minor dose modifications of thyroid medications are acceptable). Other exclusionary comorbid conditions include thalassemia, moderate to severe malabsorptive syndromes and HIV. Patients diagnosed with the above conditions or similar comorbid and/or inflammatory diseases associated with changes in BMD either from the disease process or the therapy of such condition(s) during the course of the study will be removed from the study at the point of diagnosis.
•Lobular carcinoma in situ (LCIS) or Stage IV breast cancer and patients with a concurrently active second malignancy other then adequately treated non-melanoma skin cancers or in situ cervical cancer. Patients with non-mammary malignancies, or prior breast cancer, must have been disease free for at least 5 years.
•Participation in other clinical trials that are measuring BMD as a study parameter
•Patients with conditions that are expected to distort BMD reading and make DEXA results unreliable such as bilateral prosthetic hips, extensive degenerative joint disease, or severe calcification of the aorta.
•Patients with concurrent medical or psychiatric conditions, which at the judgment of the consenting investigator, would prevent them from understanding and complying with this clinical trial.

Locations (3)

Memoral Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Memorial Sloan-Kettering Cancer Center

Commack, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

March 1, 2005

Primary Completion Date

February 1, 2009

Completion Date

February 1, 2009

Last Updated

February 26, 2009

Enrollment

ACTUAL participants

Conditions

Breast CancerOsteoporosis

Interventions

Bone Mineral Density

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 26, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Bone Mineral Density in Postmenopausal Women After Treatment for Breast Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer