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| Sponsors and Collaborators: |
University of Pittsburgh National Institutes of Health (NIH) |
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00430417 |
Purpose
The primary aim of the study is to measure bone formation in both lactating and non-lactating post-partum women and compare these to those in healthy non-pregnant controls. The secondary aim is to obtain measurements of Parathyroid Hormone-related Protein (PTHrP), markers of bone resorption, and calcium and vitamin D metabolism in these subjects. The investigators believe that lactating women will have an increase in bone resorption but no increase in bone formation when compared to non-lactating post-partum women and normal controls.
| Condition |
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Pregnancy Lactation Bone Diseases, Endocrine |
| MedlinePlus related topics: | Bone Diseases Breast Feeding Endocrine Diseases |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | A Prospective Cohort Pilot Study of Bone Metabolism in Lactating and Non-Lactating Postpartum Women and Healthy Non-Pregnant Women |
archival blood serum and plasma
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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3 groups
Group 1: post-partum breastfeeding women
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Group 2
Group 2: post-partum bottlefeeding women
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Group 3
Group 3: normal non-pregant controls who are age and race-matched to Group 1
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 21 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
New mothers who are either almost exclusively breast feeding or bottle feeding; normal controls to match those new mothers.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Mary Beth Tedesco, CRNP, MNEd | 412.383.8704 | tedesco@dom.pitt.edu |
| Contact: Linda Prebehalla, RN | 412.647.6470 | lprebeh@pitt.edu |
| United States, Pennsylvania | |||||
| University of Pittsburgh | Recruiting | ||||
| Pittsburgh, Pennsylvania, United States, 15213 | |||||
| Principal Investigator: Mara J Horwitz, MD | |||||
| Sub-Investigator: Andrew F. Stewart, MD | |||||
| Sub-Investigator: Susan M Sereika, PhD | |||||
| Sub-Investigator: Renata D Hoca, MD | |||||
| Sub-Investigator: Maryanne Hugo, MD | |||||
| Sub-Investigator: Linda Prebehalla, RN | |||||
| Sub-Investigator: Mary Beth Tedesco, CRNP, MNEd | |||||
| University of Pittsburgh |
| National Institutes of Health (NIH) |
| Principal Investigator: | Mara J Horwitz, MD | University of Pittsburgh |
More Information
University of Pittsburgh Clinical Research Study Web Site 
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| Responsible Party: | University of Pittsburgh School of Medicine ( Mara Horwitz, MD ) |
| Study ID Numbers: | 0610073, NIH RO-DK 073039 |
| First Received: | January 31, 2007 |
| Last Updated: | June 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00430417 |
| Health Authority: | United States: Federal Government |
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