Trial Information

Screening of Bone Mineral Density in Women Who Have Received Chemotherapy

It is generally accepted that women who develop breast cancer have an increased bone mineral
density (BMD) probably due to endogenous estrogen production. After menopause, BMD
decreases rather rapidly particularly during the first years after natural menopause. Bone
loss typically is more rapid and severe in a premature induced menopause (surgical,
chemotherapeutically, or hormonal). The bone loss appears to be more rapid and at an
earlier age which advances bone age to a greater degree than actual age.
Chemotherapeutically-induced menopause accelerates this process by an average of 10 years.
GnRH agonist in premenopausal women causes amenorrhea in >95% with associated loss of both
cortical and trabecular bone. In women undergoing ovarian ablation therapy, losses in bone
mass as high as 13% have been reported in the first year of treatment. Premenopausal women
who by treatment become amenorrheic remain amenorrheic posttreatment in the vast majority of
cases. Adjuvant therapy for cancer can exaggerate bone mineral density loss. Chemotherapy
may have an effect on estrogen levels but may also have an effect on bone loss via direct
cytotoxic effect on bone cells.

Although there is data concerning BMD in patients who have received chemotherapy as children
and in men with prostate cancer, there is very little data concerning BMD in gynecologic
oncology patients who have received chemotherapy. Several different chemotherapeutic agents
have been incriminated in their effects on the bone mineral density. The alkylating drugs,
particularly Cytoxan, have been shown to decrease bone mineral density. Methotrexate and
more recently the taxanes appear to have the same effect. Since most chemotherapy today is
given as a combination, one or more of the cytoxic agents on the bone are included and
therefore this study will evaluate any postmenopausal women who has received chemotherapy.

Data collection:

Women participating in this study will undergo two scans: a Heel Scan which measures the
bone mineral density in the heel area and a DXA scan which measures bone mineral density in
the lumbar region of the spine and the hip. Both scans provide a T-score and a Z-score for
the subject.