Bone Accrual and Hormones in Response to Lactation
This trial is active, not recruiting.
|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.
The association of change in bone density and change in IGF-1 axis hormones during lactation and weaning
time frame: ~Two Years
The association of changes in bone density and change in bone turnover markers during lactation and weaning.
time frame: ~Two years
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
|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.|
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