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NCT00004993 · ClinicalTrials.gov registry record · Phase 2
Can Parathyroid Hormone Injections Reverse Glucocorticoid-induced Osteoporosis
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
NCT00004993 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
The verdict
NCT00004993, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
Study Summary
Glucocorticoids are potent anti-inflammatory and immunosuppressive agents. However, prolonged use of these potent agents results in severe bone loss and osteoporotic fractures. Parathyroid hormone (1-34), when given as a daily injection has been found to dramatically increase bone mass in osteoporotic animals and postmenopausal women. The purpose of this study is to determine whether 2 years of daily PTH (1-34) injections will increase bone mass and reduce the development of new fractures. In addition, we will follow the study subjects for 2 more years to determine which type of anti-resorptive agent is required to maintain the newly formed bone. We are enrolling postmenopausal women that are on chronic corticosteroid therapy (prednisone etc.) and have bone loss (osteopenia by DXA) to be a part of this four-year-long study. The patients will receive two-year therapy with either PTH (1-34) or placebo, and for the second part of the study subjects receive either estrogen and placebo or alendronate and placebo. We will measure bone gain by standard bone densitometry, special x-rays of the spine and hip, and serum and urine bone markers.
Interventions
- DRUG Parathyroid hormone (hPTH 1-34)
Trial Details
| Field | Value |
|---|---|
| Start Date | 1999-08 |
| Est. Completion | 2001-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00004993
The ClinicalTrials.gov registry entry for NCT00004993 describes a study currently listed as completed, categorized as Phase 2. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Parathyroid hormone (hPTH 1-34) is the first listed.
NCT00004993 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00004993 about?
NCT00004993 is a clinical study titled "Can Parathyroid Hormone Injections Reverse Glucocorticoid-induced Osteoporosis". Glucocorticoids are potent anti-inflammatory and immunosuppressive agents. However, prolonged use of these potent agents results in severe bone loss and osteoporotic fractures. Parathyroid hormone (1-34), when given as a daily injection has been found to dramatically increase bone mass in osteoporot...
What is the current status of trial NCT00004993?
This trial is currently completed. It is a Phase 2 study. The study started on 1999-08. Estimated completion is 2001-08.
What interventions are being tested in trial NCT00004993?
The interventions under investigation include: Parathyroid hormone (hPTH 1-34) (DRUG).
Who is sponsoring clinical trial NCT00004993?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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