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NCT01558115 · ClinicalTrials.gov registry record · Phase 4
Denosumab in Primary Hyperparathyroidism
A Phase 4 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
NCT01558115 is a Phase 4 study that was terminated before completion, run by Columbia University. The registered enrollment target is 8 participants.
The verdict
NCT01558115, a Phase 4 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
Study Summary
Primary hyperparathyroidism (PHPT), a disease characterized by excess parathyroid hormone (PTH) and high blood calcium, is one of the most common endocrine disorders. PHPT is seen most often in postmenopausal women. Many patients with PHPT have low bone mineral density (BMD) when bone mass is measured by dual energy x-ray absorptiometry (DXA), primarily at the forearm. There is currently no effective medical therapy which increases bone density at the forearm in patients with PHPT. PTH both builds and breaks down bone, and the pathways by which PTH mediates these actions are beginning to be identified. Prior research suggests that RANKL, a molecule important in bone metabolism, responds to PTH, and that if the RANKL is inactivated, PTH is shifted towards building bone. The investigators will study the effect of Denosumab, a therapeutic agent that binds to and inactivates RANKL, in 28 postmenopausal women with PHPT. Our hypothesis is that Denosumab will increase bone mineral density in primary hyperparathyroidism. The study will last two years, and subjects will be randomly assigned to receive either placebo or Denosumab for the first year of the study. In the second year, all subjects will receive Denosumab. Denosumab (60 mg) or placebo will be given every 6 months by an injection just under the skin. Study procedures performed will include bone mineral density tests by DXA, high-resolution peripheral quantitative computed tomography (HR-pQCT) scans, and assessments of biochemical markers of calcium metabolism and bone turnover using both blood and urine samples of subjects with PHPT.
Interventions
- OTHER Placebo
- DRUG Denosumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01558115
The ClinicalTrials.gov registry entry for NCT01558115 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01558115 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01558115 about?
NCT01558115 is a clinical study titled "Denosumab in Primary Hyperparathyroidism". Primary hyperparathyroidism (PHPT), a disease characterized by excess parathyroid hormone (PTH) and high blood calcium, is one of the most common endocrine disorders. PHPT is seen most often in postmenopausal women. Many patients with PHPT have low bone mineral density (BMD) when bone mass is measur...
What is the current status of trial NCT01558115?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2012-01. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01558115?
The interventions under investigation include: Placebo (OTHER), Denosumab (DRUG).
Who is sponsoring clinical trial NCT01558115?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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