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Bone Accrual and Hormones in Response to Lactation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of North Carolina
Information provided by (Responsible Party):
Sue Brown, University of Virginia
ClinicalTrials.gov Identifier:
NCT01563094
First received: March 22, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  Purpose

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.


Condition
Lactation

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:

U.S. FDA Resources

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.

  Eligibility

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.

Criteria

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 ClinicalTrials.gov identifier: NCT01563094

Locations
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
Investigators
Principal Investigator: Sue Brown, MD UVA
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013