Bone Accrual and Hormones in Response to Lactation
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Bone Accrual and Hormones in Response to Lactation|
- The association of change in bone density and change in IGF-1 axis hormones during lactation and weaning [ Time Frame: ~Two Years ] [ Designated as safety issue: No ]
- The association of changes in bone density and change in bone turnover markers during lactation and weaning. [ Time Frame: ~Two years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||January 2003|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
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.
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Sue Brown, MD||UVA|