Study of Low Bone Mass in Premenopausal or Perimenopausal Women

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Primary Purpose

Status

Completed

Phase

Locations

United States

Study Type

Observational

Intervention

About this trial

This is an observational trial for Osteoporosis focused on measuring disease-related problem/condition, osteoporosis, rare disease

Eligibility Criteria

16 Years - 54 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Columbia University College of Physicians and Surgeons

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00005101

First Posted

April 6, 2000

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT00005101

Brief Title

Study of Low Bone Mass in Premenopausal or Perimenopausal Women

Study Type

Observational

2. Study Status

Record Verification Date

December 2003

Overall Recruitment Status

Completed

Study Start Date

February 1998 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

Columbia University

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

Keywords

disease-related problem/condition, osteoporosis, rare disease

7. Study Design

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

54 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth Shane

Organizational Affiliation

Columbia University

Official's Role

Study Chair

Facility Information:

Facility Name

Columbia University College of Physicians and Surgeons

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Osteoporosis

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial