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NCT00006180 · ClinicalTrials.gov registry record · Phase 4
Bone Loss in Premenopausal Women With Depression
A Phase 4 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 4
- Development phase
- 220
- Enrollment target
NCT00006180 is a Phase 4 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 220 participants.
The verdict
NCT00006180, a Phase 4 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 220 participants
- Enrollment target
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.
Interventions
- DRUG Alendronate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2000-08-10 |
| Est. Completion | 2007-01-19 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006180
The ClinicalTrials.gov registry entry for NCT00006180 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Alendronate is the first listed.
NCT00006180 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00006180 about?
NCT00006180 is a clinical study titled "Bone Loss in Premenopausal Women With Depression". 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. Depre...
What is the current status of trial NCT00006180?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 220 participants. The study started on 2000-08-10. Estimated completion is 2007-01-19.
What interventions are being tested in trial NCT00006180?
The interventions under investigation include: Alendronate (DRUG).
Who is sponsoring clinical trial NCT00006180?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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