Study of Low Bone Mass in Premenopausal or Perimenopausal Women

Osteoporosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005101
• Other study ID #: NCRR-M01RR00645-2738
• Secondary ID: CPMC-IRB-8414CPM
• Status: Completed
• Phase: N/A
• First received: April 6, 2000
• Last updated: June 23, 2005
• Start date: February 1998

Study information

• Verified date: December 2003
• Source: National Center for Research Resources (NCRR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

OBJECTIVES:

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 54 Years

Eligibility

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 Design

Primary Purpose: Screening

Related Conditions & MeSH terms

• Osteoporosis

Locations

Country	Name	City	State
United States	Columbia University College of Physicians and Surgeons	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	Columbia University

Country where clinical trial is conducted

United States,