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African-American Bone Metabolism and Lactation Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00785824
First Posted: November 5, 2008
Last Update Posted: October 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Mara Horwitz, University of Pittsburgh
  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.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
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

Resource links provided by NLM:


Further study details as provided by Mara Horwitz, University of Pittsburgh:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
New African-American mothers who are either almost exclusively breast-feeding or bottle-feeding; normal controls to match the lactating mothers
Criteria

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, musculoskeletal, 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
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): NCT00785824


Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Mara J Horwitz, M.D. University of Pittsburgh
  More Information

Additional Information:
Publications:

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 ( U.S. NIH Grant/Contract )
First Submitted: November 4, 2008
First Posted: November 5, 2008
Last Update Posted: October 31, 2013
Last Verified: October 2013

Keywords provided by Mara Horwitz, University of Pittsburgh:
Lactation
Endocrine System Diseases
Musculoskeletal System Disease
Hormone
Physiological Properties

Additional relevant MeSH terms:
Bone Diseases
Endocrine System Diseases
Bone Diseases, Endocrine
Musculoskeletal Diseases