Skip to main content
OpenTrials
Completed

NCT Number: NCT00376662

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoporosis Asthma Bone Diseases Bone Diseases, Metabolic Bronchial Diseases Fractures, Bone Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Wounds and Injuries

Age range

0 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Chest Medicine, Llandough Hospital, Cardiff, Wales, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hormone Replacement Therapy and Etidronate

Drug

Primary outcomes

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

Secondary outcomes

  1. Unwanted effects

Sponsors and collaborators

Lead sponsor

British Thoracic Society

Other

Registry information

Official study title

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

Important dates

Study start
1992
Study completion
2000
First posted
Sep 15, 2006
Registry last updated
Sep 15, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.