African-American Bone Metabolism and Lactation Study
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Purpose
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.i. NTX - N-telopepetide of collagen cross-links, CTX - C-telopepetide of collagen cross-links, and osteocalcin), BSAP - bone specific alkaline phosphatase and osteocalcin), 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 |
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Lactation Bone Diseases, Endocrine |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
archival blood serum and plasma
| Enrollment: | 58 |
| Study Start Date: | January 2009 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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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
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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.
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3 - AA Normal Controls
Group 3: Normal African-American non-pregnant controls who are age-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 African-American mothers who are either almost exclusively breast-feeding or bottle-feeding; normal controls to match the lactating mothers
Inclusion Criteria:
- Group 1: Post-partum (singleton pregnancy) African-American women who are exclusively breastfeeding, defined as 1 or fewer bottles of supplemental formula/day.
- Group 2: Post-partum (singleton pregnancy) African-American women are non-lactating, which is defined as bottle-feeding or having weaned their baby from breastfeeding for at least 4 weeks prior to study.
- Group 3: Controls- Healthy non-pregnant African-American women will be race and age-matched to the breast-feeding women in group one. They may not have been lactating or pregnant within the last year.
Exclusion Criteria:
- Subjects with cardiac, hypertensive, vascular, renal (serum creatinine of >1.5), pulmonary, endocrine, musculo-skeletal, hepatic, hematologic or malignant or rheumatologic disease will be excluded from the study.
- Smokers and those with a history of significant alcohol or drug abuse are excluded.
- Baseline hypertension (systolic BP > 160 mm/Hg) or hypotension (systolic BP < 90 mm/Hg).
- Subjects taking any chronic medications except stable doses of thyroid hormone, prenatal, vitamin supplements, or oral contraceptives.
- Those who have received any investigational drug in past 90 days will be excluded from the study.
- Women who are currently pregnant will be excluded from the study. Women who became pregnant by In Vitro Fertilization IVF or any hormonal manipulation (i.e. fertility drugs such as clomid ®) are also excluded, as they may have an altered pre-pregnant hormonal state. All women will have a urine pregnancy test performed at each of the two study visits and must not be pregnant in order to continue in the study. Subjects are not allowed to donate blood between study visits.
Contacts and Locations| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Mara J Horwitz, M.D. | University of Pittsburgh |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mara Horwitz, Associate Professor of Medicne, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00785824 History of Changes |
| Other Study ID Numbers: | PRO08080129, R01DK073039 |
| Study First Received: | November 4, 2008 |
| Last Updated: | July 6, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Pittsburgh:
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Lactation Endocrine System Diseases Musculoskeletal System Disease Hormone Physiological Properties |
Additional relevant MeSH terms:
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Bone Diseases Bone Diseases, Endocrine Endocrine System Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013