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NCT01152580 · ClinicalTrials.gov registry record · Phase 1
Melatonin Osteoporosis Prevention Study
A Phase 1 study of Osteoporosis and Osteopenia, sponsored by Duquesne University.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT01152580 is a Phase 1 study of Osteoporosis and Osteopenia that has completed, run by Duquesne University. The registered enrollment target is 19 participants, below the 1,546-participant average among 84 other Osteoporosis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01152580, a Phase 1 study of Osteoporosis and Osteopenia, has completed, sponsored by Duquesne University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
Osteoporosis is one of the most common skeletal disorders. Today in the United States, 10 million individuals have osteoporosis and 34 million more have low bone mass or osteopenia, which places them at an increased risk of some day developing osteoporosis. Of the people affected by this problem, 68% are women.The current thinking on the development of osteoporosis is that the changes in bone turnover that occur with aging play a major factor. Many modalities of treatment are used to prevent the bone loss and increased fracture risk associated with osteoporosis and osteopenia. Melatonin supplementation may be another treatment modality that lowers risk of hip fracture in perimenopausal women. Melatonin can remodel bone in animal models and in culture. Melatonin works through melatonin receptors to form osteoblasts from human mesenchymal stem cells and has been shown to inhibit osteoclast activity in rodents. Melatonin levels have been correlated with modulating bone markers; low nocturnal levels of melatonin correlate with in an increase in bone marker metabolism and osteoporosis. It is been shown that women who have worked night-shifts for greater than 20 years have increased risk for wrist and hip fractures. Night-shift workers have lower nocturnal melatonin levels than people who do not work the night-shift. The addition of exogenous melatonin suppresses bone marker metabolism. In human stem cells taken from bone marrow, melatonin increases the activity of bone-forming cells called osteoblasts. It is hypothesized that melatonin will improve bone health, menopausal quality of life and sleep compared to placebo in perimenopausal women. In particular, the investigators expect perimenopausal women taking melatonin to show an improvement in overall bone health as revealed by a reduction in bone marker turnover since bone resorption increases more so than bone absorption in this population compared to those women taking placebo. We also expect that perimenopausal women
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT melatonin
- DIETARY_SUPPLEMENT sugar pill
Study Locations (1)
Pennsylvania
- Duquesne University School of Pharmacy Center for Pharmacy Care - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2008-09 |
| Est. Completion | 2010-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01152580
The ClinicalTrials.gov registry entry for NCT01152580 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,546-participant average among 84 other Osteoporosis trials with a reported enrollment target (99% lower). The listed sponsor is Duquesne University, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Osteoporosis appearing as the primary indexed condition, and to 2 interventions - of which melatonin is the first listed.
NCT01152580 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01152580 about?
NCT01152580 is a clinical study titled "Melatonin Osteoporosis Prevention Study". Osteoporosis is one of the most common skeletal disorders. Today in the United States, 10 million individuals have osteoporosis and 34 million more have low bone mass or osteopenia, which places them at an increased risk of some day developing osteoporosis. Of the people affected by this problem, 68...
What is the current status of trial NCT01152580?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2008-09. Estimated completion is 2010-07.
What conditions does trial NCT01152580 study?
This clinical trial studies the following conditions: Osteoporosis, Osteopenia.
What interventions are being tested in trial NCT01152580?
The interventions under investigation include: melatonin (DIETARY_SUPPLEMENT), sugar pill (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01152580?
This trial is sponsored by Duquesne University, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01152580 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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