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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00376662
Recruitment Status : Completed
First Posted : September 15, 2006
Last Update Posted : September 15, 2006
Information provided by:
British Thoracic Society

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Hormone Replacement Therapy and Etidronate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : August 1992
Study Completion Date : October 2000

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. Unwanted effects

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 59 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00376662

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United Kingdom
Department of Chest Medicine, Llandough Hospital
Cardiff, Wales, United Kingdom, CF62 2XX
Department of Chest Medicine, Llandough Hospital,
Cardiff, Wales, United Kingdom, CF64 2XX
Sponsors and Collaborators
British Thoracic Society
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Study Director: Roger M Francis, MD School of Clinical Medical Studies University of Newcastle, UK.
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00376662    
Other Study ID Numbers: BTS HRT and Etidronate Study
First Posted: September 15, 2006    Key Record Dates
Last Update Posted: September 15, 2006
Last Verified: September 2006
Keywords provided by British Thoracic Society:
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Etidronic Acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents