Trial record 2 of 119 for:    Open Studies | "Bone Density"

Longitudinal Lactation Bone Density Study

This study is not yet open for participant recruitment.
Verified June 2012 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Mara Horwitz, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01630629
First received: June 20, 2012
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

Changes in maternal calcium metabolism are necessary during lactation to provide adequate calcium in breast milk for development of the newborn skeleton. The calcium in milk is derived from the maternal skeleton, resulting in significant bone loss, a process thought to be mediated by the actions of parathyroid hormone-related protein (PTHrP) in combination with a decreased estrogen levels. After weaning, bone lost during lactation is rapidly regained.

Differences between African-American and Caucasian bone metabolism are well documented and include higher bone mineral density (BMD), lower risk of fragily fracture, lower 25-hydroxyvitamin D (25(OH) D), and higher PTH in African-Americans compared to Caucasians. Most studies of bone metabolism in lactating women have been done in Caucasians. Because of differences in bone metabolism between African-Americans and Caucasians, we do not know whether African-Americans will have similar findings.

The primary aim of this study is to compare the changes in bone mineral density (BMD) during lactation in African-Americans with those in Caucasians. It is not known whether the loss in BMD during lactation will be the same for both races. African-Americans display skeletal resistance to PTH with short-term infusions and have lower bone resorption, higher BMD and lower fracture risk than Caucasians. A recent study by our group indicated that lactating African-American mothers had slightly lower bone resorption but quantitatively similar bone formation compared to Caucasians. However, there was a significant increase of 2-3 fold in markers of bone formation and resorption in both groups. Therefore, it is currently not known whether the loss in BMD during lactation will be the same for both races. Primary outcome measures in this study will include spine, hip and radius BMD by DXA during lactation (at 2,12 and 24 weeks postpartum or at weaning if prior to 24 weeks postpartum, and six months after weaning (+1 week). This longitudinal protocol will distinguish between two hypotheses. Either: a) as measured by BMD, bone loss in African-Americans during lactation will be equal to that in Caucasians, and skeletal recovery will be the same or possibly accelerated compared to Caucasians; or, b) African-Americans will be resistant to bone loss during lactation compared to Caucasians because of resistance to Parathyroid Hormone-related Protein (PTHrP).


Condition
Lactation
Other Disorders of Bone Density and Structure
Endocrine; Complications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: "Bone Density and Calcitropic Hormones During Lactation in African-American and Caucasian Women"

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Change from baseline in bone density measurements (BMD) [ Time Frame: Change from baseline in BMD at 2,12, 24 weeks postpartum, and six months after weaning. ] [ Designated as safety issue: No ]
    Primary outcome measures will include spine, hip and radius BMD by DXA at 2, 12, and 24 weeks post-partum and 6 months post-weaning.


Secondary Outcome Measures:
  • Change from baseline in bone metabolism parameters [ Time Frame: Change from baseline at 2, 12,and 24 weeks postpartum, and six months after weaning. ] [ Designated as safety issue: No ]
    measurement of markers of bone turnover, other calcium metabolic parameters such as calcium, phosphorus, fractional excretion of calcium, PTH(1-84), PTHrP, vitamin D metabolites, estradiol, SHBG, prolactin, and breast milk calcium levels.


Biospecimen Retention:   Samples Without DNA

Blood and breast milk


Estimated Enrollment: 80
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
African-American Lactating Women
Healthy African-American women who are exclusively breast-feeding.
Caucasian Lactating Women
Healthy Caucasian women who are exclusively breast-feeding.

  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
Study Population

New mothers will be recruited from UPMC hospital population, primarily Magee Womens Hospital. As this is a study which aims to describe racial differences in bone metabolism during lactation in African-Americans and Caucasians, subjects must identify themselves as belonging to one of these groups.

Criteria

Inclusion Criteria:

  • 21-45 years old
  • Post-partum after a singleton pregnancy
  • Exclusively breast-feeding (not more than one supplemental bottle of formula per day)
  • African-American or Caucasian by self-identification

Exclusion Criteria:

  • Subjects with cardiac, hypertensive, vascular, renal (serum creatinine of >1.5), pulmonary, endocrine, musculoskeletal, hepatic, hematologic, malignant or rheumatologic disease
  • Fractures or bone surgery within the past 12 months
  • Smokers and subjects with history of significant alcohol or drug use
  • Pregnant women
  • Women who achieved pregnancies with IVF or other hormonal manipulation
  • Women who had significant complications with the most recent pregnancy or who are unable to exclusively breastfeed beginning at birth
  • Subjects on chronic medications other than
  • stable doses of thyroid hormone
  • oral contraceptives
  • vitamin supplements
  • Women on Depo-Provera will be excluded
  • Receiving an investigational drug within 90 days
  • Weight greater than 130 kg
  • Z-score -3.0 or less (hip or spine) on initial DXA
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630629

Contacts
Contact: Mary Beth Tedesco, MNED, CRNP 412-864-3265 tedesco@pitt.edu
Contact: Angela Laslavic, MS 412-578-9259 and70@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Sub-Investigator: Marilyn Augustine, MD         
Principal Investigator: Mara J Horwitz, MD         
Sub-Investigator: Andrew F Stewart, MD         
Sub-Investigator: Mary Beth Tedesco, MNEd, CRNP         
Sub-Investigator: Angela Laslavic, MS         
Sub-Investigator: Susan M Sereika, PhD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Mara Horwitz University of Pittsburgh
  More Information

Publications:

Responsible Party: Mara Horwitz, Associate Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01630629     History of Changes
Other Study ID Numbers: PRO12050600
Study First Received: June 20, 2012
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Lactation
Weaning
Bone Density
Endocrine
Physiological Properties
Bone Metabolism

Additional relevant MeSH terms:
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 15, 2014