Skip to main content
OpenTrials
Completed

NCT Number: NCT01563094

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The association of change in bone density and change in IGF-1 axis hormones during lactation and weaning

    Time frame: ~Two Years

Secondary outcomes

  1. The association of changes in bone density and change in bone turnover markers during lactation and weaning.

    Time frame: ~Two years

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • University of North Carolina

Registry information

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Mar 26, 2012
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.