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Bone Accrual and Hormones in Response to Lactation

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ClinicalTrials.gov Identifier: NCT01563094
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : October 25, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Lactation

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.

Study Design

Study Type : Observational
Actual Enrollment : 141 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bone Accrual and Hormones in Response to Lactation
Study Start Date : January 2003
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. The association of change in bone density and change in IGF-1 axis hormones during lactation and weaning [ Time Frame: ~Two Years ]

Secondary Outcome Measures :
  1. The association of changes in bone density and change in bone turnover markers during lactation and weaning. [ Time Frame: ~Two years ]

Biospecimen Retention:   Samples Without DNA
Blood samples.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sue Brown, Assistant Professor of Medicine, University of Virginia
ClinicalTrials.gov Identifier: NCT01563094     History of Changes
Other Study ID Numbers: 12441
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified IPD may be available by direct request of Principal Investigator.

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

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