Osteoporosis has become one of the most widely recognized disorders of our times affecting an estimated 25 million women in this country. Recent evidence has suggested that premenstrual syndrome (PMS) is associated with a calcium deficiency state and bone loss. This may place premenopausal women at greater risk for osteoporosis. An entity such as PMS may be an important physiological marker of a calcium disturbance. The purpose of this investigation is to understand more completely the extent to which calcium balance is disturbed in severe PMS or Premenstrual Dysphoric Disorder (PMDD) by utilizing new tools to assess calcium and bone turnover. The long term objective is to elucidate the pathophysiology of PMDD or severe PMS as it relates to calcium hormones and bone markers. The experimental design involves the comparison between women witn severe PMS and asymptomatic controls.

Condition	Treatment or Intervention
Premenstrual Syndrome	Procedure: Measures of calcium and bone turnover

Further Study Details: 

Ages Eligible for Study:  18 Years   -   45 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Medical history of severe PMS for the PMS group
• No medical history of PMS for the control group
• Prospective 2 month documentation of moderate to severe symptoms for the PMS group
• Prospective 2 month documentation of absent symptoms for the control group
• General good health
• Regular menstrual cycles
• No history of metabolic bone disease

Exclusion Criteria:

• Amenorrhea
• Anorexia nervosa
• Malabsorption
• Inflammatory bowel disease
• Erosive gastrointestinal disease
• Gastrectomy
• Malignancy
• Multiple myeloma
• Primary hyperparathyroidism
• Use of suppressive doses of thyroxine
• Cushing's syndrome
• Use of glucocorticoids or anticonvulsants
• Use of diuretics
• Metabolic bone disease
• Pregnancy or perimenopause or menopause
• Mental retardation
• Menstrual irregularity
• Significant gynecologic abnormality
• Use of birth control pills

New York
      St. Luke's-Roosevelt Hospital, New York,  New York,  10019,  United States

Study chairs or principal investigators

Susan Thys-Jacobs, MD,  Principal Investigator,  St.Luke's-Roosevelt Hospital- Columbia Presbyterian Medical Center   

Study ID Numbers:  STHYS-JACOBS; DK57869-01
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  April 19, 2000
ClinicalTrials.gov Identifier:  NCT00005119
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08