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

This study has been completed.
Sponsor:
Information provided by:
British Thoracic Society
ClinicalTrials.gov Identifier:
NCT00376662
First received: September 13, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted

September 13, 2006
September 13, 2006
August 1992
Not Provided
New symptomatic fractures, new or worsening morphometric fractures of the throaco-lumbar spine, and changes in bone mineral density.
Same as current
No Changes Posted
Unwanted effects
Same as current
Not Provided
Not Provided
 
HRT Versus Etidronate for Osteoporosis and Fractures in Asthmatics Receiving Glucocorticoids.
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoporosis
Drug: Hormone Replacement Therapy and Etidronate
Not Provided
Campbell IA, Douglas JG, Francis RM, Prescott RJ, Reid DM; Research Committee of the British Thoracic Society. Hormone replacement therapy (HRT) or etidronate for osteoporosis in postmenopausal asthmatics on glucocorticoids: a randomised factorial trial. Scott Med J. 2009 Feb;54(1):21-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
750
October 2000
Not Provided

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.
Female
up to 59 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00376662
BTS HRT and Etidronate Study
Not Provided
Not Provided
British Thoracic Society
Not Provided
Study Director: Roger M Francis, MD School of Clinical Medical Studies University of Newcastle, UK.
British Thoracic Society
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP