African-American Bone Metabolism and Lactation Study
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|ClinicalTrials.gov Identifier: NCT00785824|
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : October 31, 2013
The primary aim of this study is to obtain measures of amino-terminal telopeptides of procollagen 1 (P1NP), a marker of bone formation, in lactating and non-lactating post-partum African-American women both at 6-8 and at 12-14 weeks post-partum, and to compare these values to those of normal controls. The secondary aim is to obtain at the same time points, measurements of Parathyroid Hormone-related Protein (PTHrP), additional markers of bone turnover [e.g. N-telopeptide of collagen cross-links (NTx), C-telopeptide of collagen cross-links (Ctx),bone specific alkaline phosphatase (BSAP) and osteocalcin (OC)], calcium and vitamin D metabolism in these subjects. These results will be compared with a non-African-American cohort of post-partum women and normal controls.
The investigators hypothesize that African-American lactating women will have increased bone turnover when compared to non-lactating postpartum women and normal controls. The investigators further hypothesize that bone turnover is increased in lactating women independent of race.
|Condition or disease|
|Lactation Bone Diseases, Endocrine|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||58 participants|
|Official Title:||A Prospective Cohort Pilot Study of Bone Metabolism in Lactating and Non-lactating Postpartum African-American Women and Healthy Non-pregnant African-American Women|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
1 A-A Breastfeeding Mothers
Group 1: Postpartum African-American breastfeeding women at 6-8 weeks post childbirth, and again at 12-14 weeks post childbirth
2 - AA Bottlefeeding Mothers
Group 2: Postpartum African-American bottlefeeding women at 6-8 weeks post childbirth and again at 12-14 weeks post childbirth.
3 - AA Normal Controls
Group 3: Normal African-American non-pregnant controls who are age-matched to Group 1
- Measurements of amino-terminal telopeptides of procollagen 1 (P1NP), a marker of bone formation, in lactating and non-lactating post-partum African-American women both at 6-8 and at 12-14 weeks post-partum and normal controls [ Time Frame: 4 months ]
- Measurements of Parathyroid Hormone-related Protein (PTHrP), additional markers of bone turnover (i.e. NTX - N-telopepetide of collagen cross-links, CTX - C-telopepetide of collagen cross-links, BSAP - bone specific alkaline phosphatase and osteocalcin), [ Time Frame: 4 months ]
Biospecimen Retention: Samples Without DNA
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): NCT00785824
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Mara J Horwitz, M.D.||University of Pittsburgh|