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NCT01656629 · ClinicalTrials.gov registry record · NA
Stem Cell Recruitment in Osteoporosis Therapy
A NA study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- NA
- Development phase
- 55
- Enrollment target
NCT01656629: Clinical Trial NA study, sponsored by Johns Hopkins University.
NCT01656629 is a NA study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 55 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01656629, a NA study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
Study Summary
Osteoporosis is an important health problem in the rapidly-aging demographic. Fragility fractures are devastating consequences of osteoporosis. The most common treatment approach in osteoporosis is inhibition of bone resorption with drugs like alendronate (ALN). Parathyroid hormone (PTH) stimulates bone formation and is the only anabolic drug available. Dual therapy with ALN and PTH is not as effective as single-drug therapy in preventing fracture. Bone progenitor cells (MSCs) are recruited to sites of bone remodeling when a growth factor called Transforming Growth Factor Beta (TGF-β1) is released from bone. Different osteoporosis medicines may have differing effects on this process. The effects of ALN versus PTH on bone progenitor recruitment in humans are unknown. This is a randomized, clinical trial of ALN, PTH, and calcium and vitamin D in post-menopausal women with low bone mass. Women will be treated for 3 months with ALN or PTH or calcium and vitamin D. Data collected will include bone biopsies for histomorphometry and micro computed tomography (µCT), bone marrow aspirates for molecular studies, peripheral blood to detect circulating bone progenitor cells and dual X-ray absorptiometry. The investigators hypothesize that in humans, PTH will 1) increase bone progenitor number, 2) enhance recruitment of bone progenitor cells to bone resorption sites, and 3) increase bone progenitor number in peripheral circulation. Furthermore, the investigators hypothesize that ALN treatment will have the opposite effect. Understanding the differences in bone progenitor cell activity and recruitment during osteoporosis therapy will provide a mechanistic rationale for effective use of PTH and anti-resorptive drugs in osteoporosis treatment.
Interventions
- DRUG Teriparatide
- DRUG Alendronate
- DIETARY_SUPPLEMENT calcium and vitamin D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2012-08 |
| Est. Completion | 2020-08-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01656629
The ClinicalTrials.gov registry entry for NCT01656629 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Teriparatide is the first listed.
NCT01656629 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01656629 about?
NCT01656629 is a clinical study titled "Stem Cell Recruitment in Osteoporosis Therapy". Osteoporosis is an important health problem in the rapidly-aging demographic. Fragility fractures are devastating consequences of osteoporosis. The most common treatment approach in osteoporosis is inhibition of bone resorption with drugs like alendronate (ALN). Parathyroid hormone (PTH) stimulates ...
What is the current status of trial NCT01656629?
This trial is currently terminated. It is a NA study. The enrollment target is 55 participants. The study started on 2012-08. Estimated completion is 2020-08-07.
What interventions are being tested in trial NCT01656629?
The interventions under investigation include: Teriparatide (DRUG), Alendronate (DRUG), calcium and vitamin D (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01656629?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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