Bone Accrual and Hormones in Response to Lactation

Completed

• Conditions: Lactation

• Registration Number: NCT01563094
• Lead Sponsor: University of Virginia

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-26
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 141

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The association of change in bone density and change in IGF-1 axis hormones during lactation and weaning	~Two Years

Secondary Outcome Measures

Name	Time	Method
The association of changes in bone density and change in bone turnover markers during lactation and weaning.	~Two years

Trial Locations

Locations (1)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States