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Low-Dose Hormone Replacement Therapy and Alendronate for Osteoporosis

NCT00000430 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2007-01-04

No results posted yet for this 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.

Conditions

Interventions

DRUG

Alendronate

DRUG

Estrogen/progestin therapy

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    lead NIH

Principal Investigators

  • Robert R. Recker, MD · Creighton University Osteoporosis Research Center

  • Joan M. Lappe, PhD, RN · Creighton University Osteoporosis Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1999-10-31
Completion
2004-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000430 on ClinicalTrials.gov