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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00399321

Enrollment

Registered

2006-11-14

Start date

2006-04-30

Completion date

2010-09-30

Last updated

2017-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Postmenopausal Bone Loss

Keywords

Post menopause women receiving adjuvant care

Brief summary

The main purpose of this study is to see what levels of Bone Mineral Density post-menopausal women with breast cancer have, and to see if the level of Bone Mineral Density changes during a women's treatment after her surgery. This trial studies changes in Bone Mineral Density and markers of of bone activity in post-menopausal women receiving treatment for early stage breast cancer.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Documented diagnosis of breast cancer * Last menstrual period occurring more than 5 years ago * Non-metastatic breast cancer tumor with the diagnosis of Tis, Tl-T4, N0-3, M0 * DCIS is allowed, but LCIS (only) is not

Exclusion criteria

* Any metabolic bone disease other than postmenopausal osteoporosis or osteopenia * Use of systemic gonadal hormonal medications or supplements within the past 24 months * Prior use of tamoxifen or raloxifene is permitted if the medication was discontinued more than 24 months prior to the diagnosis of breast cancer. * No adjuvant antiestrogen, antineoplastic, therapies are permitted on study. * Chronic use of systemic steroids for disease process other than breast cancer chemotherapy premedication or antiemetics * History of rheumatoid arthritis, ankylosing spondylitis, hyperparathyroidism, renal osteodystrophy, moderate to severe inflammatory or autoimmune disease or newly diagnosed thyroid condition requiring titration of medications. * Lobular carcinoma in situ 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. * 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 * Patients with concurrent medical or psychiatric conditions that would keep them from understanding and complying with this clinical trial.

Design outcomes

Primary

Measure	Time frame
Changes in bone mineral density in post-menopausal women receiving treatment for early stage breast cancer.	24 months

Countries

United States

Outcome results