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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: Clinical Trial Phase 3 study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 240 participants
Start Date 1999-10
Est. Completion 2004-09
Phase Phase 3

Why NCT00000430 stopped before completion

NCT00000430 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).

The record links to 0 conditions, and to 2 interventions - of which Alendronate is the first listed.

NCT00000430 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00000430's enrollment target sits among peer trials

240 1273rd of 2000 higher than 710 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00000430, the US trial registry maintained by the National Library of Medicine. NCT00000430 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.