Bone Accrual and Hormones in Response to Lactation

NCT01563094 | Completed

• 1 other identifier: 12441
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lactation

Keywords

Bone Density; Lactation; Bone Turnover Markers

Outcome Measures

Primary Outcomes (1)

• The association of change in bone density and change in IGF-1 axis hormones during lactation and weaning

  ~Two Years

Secondary Outcomes (1)

• The association of changes in bone density and change in bone turnover markers during lactation and weaning.

  ~Two years

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postpartum women from outpatient obstetrical/gynecology clinics.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• University of North Carolina: collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Sue Brown, MD

  UVA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 26, 2012
• Study Start: January 1, 2003
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)