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Bone Loss in Premenopausal Women With Depression

NCT00006180 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2017-07-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Alendronate

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-08-10
Completion
2007-01-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00006180 on ClinicalTrials.gov