NCT00005119

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started May 2000

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2000

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2000

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
Last Updated

March 2, 2010

Status Verified

March 1, 2010

First QC Date

April 19, 2000

Last Update Submit

March 1, 2010

Conditions

Premenstrual Syndrome

Keywords

Premenstrual Dysphoric DisorderSevere Premenstrual SyndromeCalcium metabolismVitamin DBone MarkersPremenopausalMenstrual Cycle

Interventions

Measures of calcium and bone turnoverPROCEDURE

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke's-Roosevelt Hospital

New York, New York, 10019, United States

Location

Related Publications (5)

  • Thys-Jacobs, Silverton M, Alvir JM et al. Reduced Bone Mass in women with Premenstrual Syndrome. J Women's Health 1995; 4:161.

    BACKGROUND

  • Thys-Jacobs S, Ceccarelli S, Bierman A, Weisman H, Cohen MA, Alvir J. Calcium supplementation in premenstrual syndrome: a randomized crossover trial. J Gen Intern Med. 1989 May-Jun;4(3):183-9. doi: 10.1007/BF02599520.

    PMID: 2656936BACKGROUND

  • Thys-Jacobs S, Starkey P, Bernstein D, Tian J. Calcium carbonate and the premenstrual syndrome: effects on premenstrual and menstrual symptoms. Premenstrual Syndrome Study Group. Am J Obstet Gynecol. 1998 Aug;179(2):444-52. doi: 10.1016/s0002-9378(98)70377-1.

    PMID: 9731851BACKGROUND

  • Thys-Jacobs S, Alvir MJ. Calcium-regulating hormones across the menstrual cycle: evidence of a secondary hyperparathyroidism in women with PMS. J Clin Endocrinol Metab. 1995 Jul;80(7):2227-32. doi: 10.1210/jcem.80.7.7608284.

    PMID: 7608284BACKGROUND

  • Lee SJ, Kanis JA. An association between osteoporosis and premenstrual symptoms and postmenopausal symptoms. Bone Miner. 1994 Feb;24(2):127-34. doi: 10.1016/s0169-6009(08)80150-x.

    PMID: 8199532BACKGROUND

MeSH Terms

Conditions

Premenstrual SyndromePremenstrual Dysphoric Disorder

Interventions

Bone Remodeling

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaRegenerationBiological Phenomena

Study Officials

  • Susan Thys-Jacobs, MD

    St.Luke's-Roosevelt Hospital- Columbia Presbyterian Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 19, 2000

First Posted

April 20, 2000

Study Start

May 1, 2000

Study Completion

October 1, 2003

Last Updated

March 2, 2010

Record last verified: 2010-03

Locations

US(1)