Bone Accrual and Hormones in Response to Lactation

Lactation Clinical Trial

Official title:

Bone Accrual and Hormones in Response to Lactation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563094
• Other study ID #: 12441
• Status: Completed
• Start date: January 2003
• Est. completion date: August 2010

Study information

• Verified date: November 2023
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lactation

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	University of North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The association of change in bone density and change in IGF-1 axis hormones during lactation and weaning		~Two Years
Secondary	The association of changes in bone density and change in bone turnover markers during lactation and weaning.		~Two years