HRT Versus Etidronate for Osteoporosis and Fractures in Asthmatics Receiving Glucocorticoids.

September 13, 2006 updated by: British Thoracic Society

HRT and/or Etidronate in the Prevention and Treatment of Osteoporosis and Fractures in Post-Menopausal Patients With Asthma Receiving Long-Term Oral and/or Inhaled Glucocorticoids:a Randomised Factorial Trial

To determine and compare the effects of Hormone replacement therapy (HRT), etidronate, HRT plus etidronate and no treatment over 5 years in the prevention and treatment of glucocorticoid-induced osteoporosis and fractures in post-menopausal women with asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Multicentre trial involving 13 hospitals in United Kingdom, with patients entered by 17 Consultant Chest Physicians. Consenting patients were randomised in a central office to either HRT, etidronate, HRT plus etidronate or no treatment. Information on the progress of the patients was requested by the co-ordinating office annually for 5 years after entry to the trial. Outcomes were measured as new symptomatic fractures,new or worsening morphometric fractures of the thoraco-lumbar spine and changes in bone mineral density.

Study Type

Interventional

Enrollment

750

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Wales
      • Cardiff, Wales, United Kingdom, CF62 2XX
        • Department of Chest Medicine, Llandough Hospital
      • Cardiff, Wales, United Kingdom, CF64 2XX
        • Department of Chest Medicine, Llandough Hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 59 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal, asthmatic outpatients under 60 years of age on long-term oral or inhaled glucocorticoid treatment for at least one year.

Exclusion Criteria:

  • Hysterectomy, history of breast or endometrial cancer, undiagnosed pelvic or breast mass, untreated hypertension.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
New symptomatic fractures, new or worsening morphometric fractures of the throaco-lumbar spine, and changes in bone mineral density.

Secondary Outcome Measures

Outcome Measure
Unwanted effects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Thoracic Society

Investigators

  • Study Director: Roger M Francis, MD, School of Clinical Medical Studies University of Newcastle, UK.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1992

Study Completion

October 1, 2000

Study Registration Dates

First Submitted

September 13, 2006

First Submitted That Met QC Criteria

September 13, 2006

First Posted (Estimate)

September 15, 2006

Study Record Updates

Last Update Posted (Estimate)

September 15, 2006

Last Update Submitted That Met QC Criteria

September 13, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTS HRT and Etidronate Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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