Bone Metabolism and Parathyroid Hormone-Related Protein (PTHrP) Lactation Study - Full Text View

Sponsor:	University of Pittsburgh
Collaborator:	National Institutes of Health (NIH)
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00430417

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:

MedlinePlus related topics: Bone Diseases Breast Feeding Endocrine Diseases Postpartum Care Vitamin D

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

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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 Institutes of Health (NIH)

Investigators

Principal Investigator:

Mara J Horwitz, MD

University of Pittsburgh

More Information

Publications:

Dobnig H, Kainer F, Stepan V, Winter R, Lipp R, Schaffer M, Kahr A, Nocnik S, Patterer G, Leb G. Elevated parathyroid hormone-related peptide levels after human gestation: relationship to changes in bone and mineral metabolism. J Clin Endocrinol Metab. 1995 Dec;80(12):3699-707.

Gundberg CM, Looker AC, Nieman SD, Calvo MS. Patterns of osteocalcin and bone specific alkaline phosphatase by age, gender, and race or ethnicity. Bone. 2002 Dec;31(6):703-8.

Horwitz MJ, Tedesco MB, Sereika SM, Hollis BW, Garcia-Ocana A, Stewart AF. Direct comparison of sustained infusion of human parathyroid hormone-related protein-(1-36) [hPTHrP-(1-36)] versus hPTH-(1-34) on serum calcium, plasma 1,25-dihydroxyvitamin D concentrations, and fractional calcium excretion in healthy human volunteers. J Clin Endocrinol Metab. 2003 Apr;88(4):1603-9.

Horwitz MJ, Tedesco MB, Sereika SM, Syed MA, Garcia-Ocana A, Bisello A, Hollis BW, Rosen CJ, Wysolmerski JJ, Dann P, Gundberg C, Stewart AF. Continuous PTH and PTHrP Infusion Causes Suppression of Bone Formation and Discordant Effects on 1,25(OH)(2)Vitamin D. J Bone Miner Res. 2005 Oct;20(10):1792-803. Epub 2005 Jun 6.

Kalkwarf HJ, Specker BL, Ho M. Effects of calcium supplementation on calcium homeostasis and bone turnover in lactating women. J Clin Endocrinol Metab. 1999 Feb;84(2):464-70.

Kovacs CS. Calcium and bone metabolism during pregnancy and lactation. J Mammary Gland Biol Neoplasia. 2005 Apr;10(2):105-18. Review.

Kovacs CS, Kronenberg HM. Maternal-fetal calcium and bone metabolism during pregnancy, puerperium, and lactation. Endocr Rev. 1997 Dec;18(6):832-72. Review. No abstract available.

Sowers M. Pregnancy and lactation as risk factors for subsequent bone loss and osteoporosis. J Bone Miner Res. 1996 Aug;11(8):1052-60. Review. No abstract available.

Sowers M, Eyre D, Hollis BW, Randolph JF, Shapiro B, Jannausch ML, Crutchfield M. Biochemical markers of bone turnover in lactating and nonlactating postpartum women. J Clin Endocrinol Metab. 1995 Jul;80(7):2210-6.

Sowers MF, Hollis BW, Shapiro B, Randolph J, Janney CA, Zhang D, Schork A, Crutchfield M, Stanczyk F, Russell-Aulet M. Elevated parathyroid hormone-related peptide associated with lactation and bone density loss. JAMA. 1996 Aug 21;276(7):549-54.

VanHouten JN, Dann P, Stewart AF, Watson CJ, Pollak M, Karaplis AC, Wysolmerski JJ. Mammary-specific deletion of parathyroid hormone-related protein preserves bone mass during lactation. J Clin Invest. 2003 Nov;112(9):1429-36.

Responsible Party:	Mara Horwitz, MD, University of Pittsburgh School of Medicine
ClinicalTrials.gov Identifier:	NCT00430417 History of Changes
Other Study ID Numbers:	0610073, NIH RO-DK 073039
Study First Received:	January 31, 2007
Last Updated:	January 23, 2009
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 February 12, 2012