Bone Accrual and Hormones in Response to Lactation

This study is ongoing, but not recruiting participants.
University of North Carolina
Information provided by (Responsible Party):
Sue Brown, University of Virginia Identifier:
First received: March 22, 2012
Last updated: August 14, 2013
Last verified: August 2013

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 Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bone Accrual and Hormones in Response to Lactation

Resource links provided by NLM:

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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

Blood samples.

Enrollment: 141
Study Start Date: January 2003
Estimated Study Completion Date: December 2014
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Postpartum women from outpatient obstetrical/gynecology clinics.


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
  Contacts and Locations
Please refer to this study by its identifier: NCT01563094

United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of Virginia
University of North Carolina
Principal Investigator: Sue Brown, MD UVA
  More Information

No publications provided

Responsible Party: Sue Brown, Assistant Professor of Medicine, University of Virginia Identifier: NCT01563094     History of Changes
Other Study ID Numbers: SAB001
Study First Received: March 22, 2012
Last Updated: August 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Bone Density
Bone Turnover Markers

Additional relevant MeSH terms:
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 23, 2014