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NCT01611571 · ClinicalTrials.gov registry record · Phase 3
Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis
A Phase 3 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 3
- Development phase
- 31
- Enrollment target
NCT01611571 is a Phase 3 study that has completed, run by Columbia University. The registered enrollment target is 31 participants.
The verdict
NCT01611571, a Phase 3 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 31 participants
- Enrollment target
Study Summary
The purpose of this study is to develop new treatment options for osteoporosis in men. The Investigators will study two medications and three treatment regimens. First, risedronate (FDA approved) will be studied as monotherapy. Second, the investigators will study injectable parathyroid hormone (PTH 134, teriparatide; FDA approved), as a therapy for male osteoporosis. PTH, a naturally occurring hormone produced by the parathyroid glands, is one of the most important regulators of bone metabolism. The drug being studied in this protocol, teriparatide, is the first aminoterminal 34 amino acids of the native 84amino acid peptide. Teriparatide contains all of the classical biological activities of native PTH. In studies of postmenopausal women, in a small study of 23 men with osteoporosis and a larger study of 437 men treatment with teriparatide led to significant increases in bone density. Although teriparatide and actonel are now approved for osteoporosis in men additional studies of these medications are needed in order to establish how best to use these drugs. This study is focused on an entirely new treatment approach, namely the combination of two medications for the treatment of osteoporosis risedronate with teriparatide to evaluate whether combination therapy is superior to therapy with either medication alone. This study is also designed to assess the extent to which risedronate maintains increases in bone density after a course of mono or combination therapy.
Interventions
- DRUG Risedronate
- DRUG Teriparatide
- DRUG Placebo Teriparatide
- DRUG placebo Risedronate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2003-12 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01611571
The ClinicalTrials.gov registry entry for NCT01611571 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 31 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 4 interventions - of which Risedronate is the first listed.
NCT01611571 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01611571 about?
NCT01611571 is a clinical study titled "Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis". The purpose of this study is to develop new treatment options for osteoporosis in men. The Investigators will study two medications and three treatment regimens. First, risedronate (FDA approved) will be studied as monotherapy. Second, the investigators will study injectable parathyroid hormone (PTH...
What is the current status of trial NCT01611571?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 31 participants. The study started on 2003-12. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01611571?
The interventions under investigation include: Risedronate (DRUG), Teriparatide (DRUG), Placebo Teriparatide (DRUG), placebo Risedronate (DRUG).
Who is sponsoring clinical trial NCT01611571?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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