Status:
COMPLETED
Bone Metabolism and Parathyroid Hormone-related Protein (PTHrP) Lactation Study
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Bone Diseases, Endocrine
Eligibility:
FEMALE
21-45 years
Brief Summary
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 obt...
Detailed Description
Pregnancy and lactation are both states of altered maternal calcium and bone metabolism which may have a significant impact on the development of peak bone mass. While these two states are characteriz...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00430417
Start Date
January 1 2007
End Date
June 1 2008
Last Update
October 31 2013
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213