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NCT00000430 · ClinicalTrials.gov registry record · Phase 3
Low-Dose Hormone Replacement Therapy and Alendronate for Osteoporosis
A Phase 3 study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Terminated
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
NCT00000430 is a Phase 3 study that was terminated before completion, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 240 participants.
The verdict
NCT00000430, a Phase 3 study, was terminated before completion, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 240 participants
- Enrollment target
Study Summary
Osteoporosis, a condition in which bones are fragile and break easily, is a major health problem for postmenopausal women. Research studies have shown that both estrogen/progestin replacement therapy (hormone replacement therapy, or HRT) and alendronate are effective in preventing and treating osteoporosis. However, because these drugs work in somewhat different ways, a combination of the two drugs might protect women from osteoporosis better than either drug alone. In this study we will test whether HRT and alendronate given together for 3.5 years to postmenopausal women with low bone mass will have a greater effect on bone than either HRT or alendronate given alone. We will also give every participant in this study calcium and vitamin D supplements.
Interventions
- DRUG Alendronate
- DRUG Estrogen/progestin therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 1999-10 |
| Est. Completion | 2004-09 |
| Phase | Phase 3 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000430
The ClinicalTrials.gov registry entry for NCT00000430 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Alendronate is the first listed.
NCT00000430 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000430 about?
NCT00000430 is a clinical study titled "Low-Dose Hormone Replacement Therapy and Alendronate for Osteoporosis". Osteoporosis, a condition in which bones are fragile and break easily, is a major health problem for postmenopausal women. Research studies have shown that both estrogen/progestin replacement therapy (hormone replacement therapy, or HRT) and alendronate are effective in preventing and treating osteo...
What is the current status of trial NCT00000430?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 1999-10. Estimated completion is 2004-09.
What interventions are being tested in trial NCT00000430?
The interventions under investigation include: Alendronate (DRUG), Estrogen/progestin therapy (DRUG).
Who is sponsoring clinical trial NCT00000430?
This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.
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