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

Information source: British Thoracic Society
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: Hormone Replacement Therapy and Etidronate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: British Thoracic Society

Official(s) and/or principal investigator(s):
Roger M Francis, MD, Study Director, Affiliation: School of Clinical Medical Studies University of Newcastle, UK.

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome: Unwanted effects

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.

Eligibility

Minimum age: N/A. Maximum age: 59 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

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

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

Additional Information

Starting date: August 1992
Last updated: September 13, 2006

Page last updated: August 20, 2015

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