Study of Low Bone Mass in Premenopausal or Perimenopausal Women

June 23, 2005 updated by: National Center for Research Resources (NCRR)

OBJECTIVES:

I. Determine the possible causes of bone loss in premenopausal or perimenopausal women.

Study Overview

Status

Completed

Conditions

Detailed Description

PROTOCOL OUTLINE: Patients undergo physical examination and complete history with emphasis on risk factors for osteoporosis and screening for occult secondary causes of osteoporosis through blood serum and 24 hour urine collection.

Patients with more than 6 months since prior bone mineral density measurements or who did not receive measurements at participating center, undergo dual energy x-ray absorptiometry over 30 minutes for bone mineral density measurements.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University College of Physicians and Surgeons

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 54 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Low bone mass (T score less than -2.0) with no secondary cause on routine exam
  • Premenopausal

OR

  • Perimenopausal

--Prior/Concurrent Therapy--

  • Chemotherapy: No prior or concurrent chemotherapeutic agents
  • Endocrine therapy: No prior or concurrent glucocorticoids or suppressive doses of thyroid hormone
  • Other: No prior or concurrent anticonvulsants

--Patient Characteristics--

  • Hematopoietic: No multiple myeloma
  • Other: No hyperparathyroidism No thyrotoxicosis No anorexia nervosa No Paget's disease of bone No rheumatoid arthritis No Cushing's syndrome No malabsorption syndrome No type I diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Columbia University

Investigators

  • Study Chair: Elizabeth Shane, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1998

Study Registration Dates

First Submitted

April 6, 2000

First Submitted That Met QC Criteria

April 6, 2000

First Posted (Estimate)

April 7, 2000

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

December 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCRR-M01RR00645-2738
  • CPMC-IRB-8414
  • CPMC-GCRC-2738

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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