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NCT01630629 · ClinicalTrials.gov registry record
Longitudinal Lactation Bone Density Study
A clinical trial, sponsored by University of Pittsburgh.
- Completed
- Registry status
- 77
- Enrollment target
NCT01630629: Completed study, sponsored by University of Pittsburgh.
NCT01630629 is a clinical trial that has completed, run by University of Pittsburgh. The registered enrollment target is 77 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01630629 has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- 77 participants
- Enrollment target
Study Summary
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 fragility 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 Dual X-Ray Absorbiometry (DXA)Scans during lactation (at 2,12 and 24 weeks postpartum or at weaning if prior to 24 weeks postpartum, and six months after
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-09 |
What the finished NCT01630629 record still lists
NCT01630629 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 77 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01630629 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01630629 about?
NCT01630629 is a clinical study titled "Longitudinal Lactation Bone Density Study". 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 ...
What is the current status of trial NCT01630629?
This trial is currently completed. The enrollment target is 77 participants. The study started on 2012-08. Estimated completion is 2015-09.
Who is sponsoring clinical trial NCT01630629?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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