This trial is active, not recruiting.

Condition lactation
Sponsor University of Virginia
Collaborator University of North Carolina
Start date January 2003
End date August 2010
Trial size 141 participants
Trial identifier NCT01563094, 12441


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

The association of change in bone density and change in IGF-1 axis hormones during lactation and weaning
time frame: ~Two Years

Secondary Outcomes

The association of changes in bone density and change in bone turnover markers during lactation and weaning.
time frame: ~Two years

Eligibility Criteria

Female participants at least 20 years old.

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

Additional Information

Official title Bone Accrual and Hormones in Response to Lactation
Principal investigator Sue Brown, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Virginia.