NCT00001413

Brief Summary

The purpose of this study is to examine calcium absorption and bone mineral density in women with depression. Research indicates that pre-menopausal women with depression have significantly lower bone mineral density (BMD) than pre-menopausal women without depression. Although the mechanisms of BMD loss are unclear, researchers believe that individuals with depression have impaired calcium absorption. However, it is unknown whether the abnormal absorption is a result of depression or a side effect of the drugs used to treat it. This study will compare calcium absorption in women with depression and in healthy women without depression. Participants in this study will be given two non-radioactive calcium isotopes. One can be taken by mouth and the other must be injected. Participants will have the level of isotopes in their urine measured to estimate true fractional calcium absorption (TFCA). Participants may also have a dual X-ray absorptiometry (DEXA) scan to measure total body adiposity and lean body mass.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
585

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 1994

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 1994

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
7.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2007

Completed
Last Updated

July 2, 2017

Status Verified

January 19, 2007

First QC Date

November 3, 1999

Last Update Submit

June 30, 2017

Conditions

Keywords

CorticosteroidsOsteoporosisDepressionDEXA ScanBody MassDual X-RayEnergy AbsorptiometryNormal Volunteer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Bipolar Disorder will be eligible if they meet the depressive episode criterion.

You may not qualify if:

  • DEPRESSED SUBJECTS:
  • Pregnant women will not be eligible to participate.
  • Known medical causes of osteoporosis, other than depression.
  • Current or past history of eating disorders, or schizophrenia, as per DSM-IV.
  • Chronic use of oral or parenteral steroids (daily use for 3 months or longer).
  • HEALTHY SUBJECTS:
  • Pregnant women will not be eligible to participate.
  • Known medical causes of osteoporosis.
  • Any history of DSM-IV diagnosis, including depression, eating disorders, and alcohol or drug abuse.
  • History or current evidence of any significant clinical or laboratory abnormalities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Mazess RB, Barden H, Ettinger M, Schultz E. Bone density of the radius, spine, and proximal femur in osteoporosis. J Bone Miner Res. 1988 Feb;3(1):13-8. doi: 10.1002/jbmr.5650030104.

    PMID: 3213603BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, MajorOsteoporosisDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesBehavioral SymptomsBehavior

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

April 6, 1994

Study Completion

January 19, 2007

Last Updated

July 2, 2017

Record last verified: 2007-01-19

Locations