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

Completed

Conditions studied: Bone Diseases, Endocrine

In brief

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.

Key facts

Study ID

NCT00430417

Run by

University of Pittsburgh

People needed

49

Starts

2007-01-01

Expected to finish

2008-06-01

Last updated by the study team

2013-10-31

Who can join

Age: 21 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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