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Bone Metabolism and Parathyroid Hormone-related Protein (PTHrP) Lactation Study

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Mara Horwitz, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00430417
First received: January 31, 2007
Last updated: July 6, 2012
Last verified: July 2012
History of Changes
  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
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 Women and Healthy Non-pregnant Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by 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 postpartum women both at 6-8 and at 12-14 weeks post-partum, and to compare these values to those of normal controls [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurements of Parathyroid Hormone-related Protein (PTHrP), markers of bone turnover, calcium and vitamin D metabolism [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

archival blood serum and plasma


Enrollment: 49
Study Start Date: January 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
3 groups
Group 1: post-partum breastfeeding women
Group 2
Group 2: post-partum bottlefeeding women
Group 3
Group 3: normal non-pregnant controls who are age and race-matched to Group 1

  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 who are either almost exclusively breast feeding or bottle feeding; normal controls to match those new mothers.

Criteria

Inclusion Criteria:

  • Healthy Caucasian, Hispanic, or Asian women between the ages of 21-45.
  • Group 1: Postpartum (singleton pregnancy) women who are exclusively breastfeeding, defined as 1 or fewer bottles of supplemental formula/day.
  • Group 2: Postpartum (singleton pregnancy) women who 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 women who are race and age-matched to the breastfeeding 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.
  • In order to narrow the statistical variations in the study population, African-Americans are excluded because of demonstrated differences in renal excretion of calcium and vitamin D absorption.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430417

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, MD University of Pittsburgh
  More Information

Publications:

Responsible Party: Mara Horwitz, Associate Professor of Medicne, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00430417     History of Changes
Other Study ID Numbers: 0610073, R01DK073039
Study First Received: January 31, 2007
Last Updated: July 6, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Pregnancy
Lactation
Endocrine System Diseases
 MusculoSkeletal System Disease
Hormone
Physiologic Properties

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

ClinicalTrials.gov processed this record on May 16, 2013