The purpose of this study is to determine whether women with major depression lose bone mass
at a faster rate than women without depression. This study will also determine if the drug
alendronate can maintain or increase bone mass in premenopausal women with major depression
and osteoporosis.
Depression may be a major risk factor for osteoporosis; it is associated with abnormally
elevated stress hormone levels that may contribute to bone loss. This study will evaluate
bone mass in women with depression and healthy volunteers.
Participants will undergo psychiatric, medical, dietary, and stress hormone evaluations and
bone mineral density (BMD) measurements.
Participants with depression will be divided into two groups: those with normal BMD and those
with low BMD. Depressed participants with normal BMD will be compared to a control group of
healthy premenopausal women with normal BMD and followed for 36 months. Dual energy X-ray
absorptiometry (DEXA) determinations will be made at months 6, 12, 24 and 36; bone turnover
and endocrine parameters of depression will be
measured every 3 to 6 months.
Participants with depression and low BMD will be randomly assigned to receive either
alendronate or placebo (an inactive pill) once a week for 24 months. Participants will
receive calcium and vitamin D supplements daily. DEXA determinations will be performed at
screening, and at Months 6, 12, 18 and 24; bone turnover and endocrine parameters of
depression will be measured every 3 to 6 months.
For both groups, up to four of the visits may optimally be done as inpatient stays of two
nights. All remaining visits are as outpatients.