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Study of Low Bone Mass in Premenopausal or Perimenopausal Women

NCT ID: NCT00005101

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

1998-02-28

Brief Summary

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OBJECTIVES:

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

Detailed Description

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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.

Conditions

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Osteoporosis

Keywords

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disease-related problem/condition osteoporosis rare disease

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

16 Years

Maximum Eligible Age

54 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role lead

Principal Investigators

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Elizabeth Shane

Role: STUDY_CHAIR

Columbia University

Locations

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Columbia University College of Physicians and Surgeons

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CPMC-IRB-8414

Identifier Type: -

Identifier Source: secondary_id

CPMC-GCRC-2738

Identifier Type: -

Identifier Source: secondary_id

NCRR-M01RR00645-2738

Identifier Type: -

Identifier Source: org_study_id