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Bone Accrual and Hormones in Response to Lactation

NCT ID: NCT01563094

Last Updated: 2023-11-30

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

Total Enrollment

141 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2010-08-31

Brief Summary

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This is a prospective observational trial of healthy postpartum women to investigate changes in bone density and markers of bone turnover during lactation. The study hypothesis is that women who breast-feed 5 months or more will lose bone density and subsequently regain the bone density after weaning. This study seeks to define determinants of the regain in bone density.

Detailed Description

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This is a prospective observational trial enrolling healthy postpartum women, ages 20 years and older with the intent to breast-feed from the UNC outpatient obstetrical clinics and the UVA outpatient obstetrical clinics. These women were studied at 3-5 visits in the year following their delivery to assess bone density, nutritional intake, exercise, and breast-feeding choices. The number of study visits depended on the timing of return of menses and interest in participating in the follow-up study (timepoints are: immediate postpartum, 3 months postpartum, return of menses, 6 months after return of menses and follow-up visit 6 months after final visit). Blood was taken for analysis of bone-related hormones, bone turnover and calcium homeostasis markers. The study focuses on women with extended lactation (at least 5 months of lactation) whereas women who cease lactation prior to 3 months will be the primary comparison group.

Conditions

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Lactation

Keywords

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Bone Density Lactation Bone Turnover Markers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* age \>20 at the time of delivery
* singleton pregnancy and
* \<2 prior pregnancies that were \>20 weeks gestation.

Exclusion Criteria

* maternal rheumatologic disorders
* maternal anorexia nervosa
* maternal endocrinologic disorders,
* medications known to affect bone density such as corticosteroids, thyroid hormone use, anticonvulsant therapy, bisphosphonates, long-term GnRH agonists use and calcitonin.
* Subsequent pregnancy during the study
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina

OTHER

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Sue Brown

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sue Brown, MD

Role: PRINCIPAL_INVESTIGATOR

UVA

Locations

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University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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12441

Identifier Type: -

Identifier Source: org_study_id