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NCT00221299 · ClinicalTrials.gov registry record · Phase 4
Risedronate and Parathyroid Hormone to Reverse Osteoporosis Caused by Chronic Steroid Use
A Phase 4 study, sponsored by University of California, Davis.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT00221299: Completed Phase 4 study, sponsored by University of California, Davis.
NCT00221299 is a Phase 4 study that has completed, run by University of California, Davis. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00221299, a Phase 4 study, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
The purpose of the study is to learn if one year of treatment with parathyroid hormone (PTH), either alone or with risedronate, will increase the thickness of the bones in the hip and spine in subjects with osteoporosis from chronic low dose steroid use. During the second year, the study will also look at whether taking risedronate will preserve the bone thickness created by one year of rhPTH 1-34 treatment.
Primary Outcome
In this randomized clinical trial to determine if treatment with rhPTH (1-34) with and without risedronate will increase bone mass of the lumbar spine more than risedronate alone. This was a small pilot study and study subjects were recruited from two study sites. Our primary endpoint was change in lumbar spine BMD.
Interventions
- DRUG Risedronate
- DRUG Parathyroid Hormone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2005-09 |
| Est. Completion | 2009-05 |
| Phase | Phase 4 |
What the finished NCT00221299 record still lists
NCT00221299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Risedronate is the first listed.
NCT00221299 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00221299 about?
NCT00221299 is a clinical study titled "Risedronate and Parathyroid Hormone to Reverse Osteoporosis Caused by Chronic Steroid Use". The purpose of the study is to learn if one year of treatment with parathyroid hormone (PTH), either alone or with risedronate, will increase the thickness of the bones in the hip and spine in subjects with osteoporosis from chronic low dose steroid use. During the second year, the study will also l...
What is the current status of trial NCT00221299?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2005-09. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00221299?
The interventions under investigation include: Risedronate (DRUG), Parathyroid Hormone (DRUG).
Who is sponsoring clinical trial NCT00221299?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00221299's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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