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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
  Purpose

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 Intervention Phase
Osteoporosis
 Drug: Hormone Replacement Therapy and Etidronate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by British Thoracic Society:

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

Secondary Outcome Measures:
  • Unwanted effects

Estimated Enrollment: 750
Study Start Date: August 1992
Estimated Study Completion Date: October 2000
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

Ages Eligible for Study:   up to 59 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376662

Locations
United Kingdom
Department of Chest Medicine, Llandough Hospital,
Cardiff, Wales, United Kingdom, CF64 2XX
Department of Chest Medicine, Llandough Hospital
Cardiff, Wales, United Kingdom, CF62 2XX
Sponsors and Collaborators
British Thoracic Society
Investigators
Study Director: Roger M Francis, MD School of Clinical Medical Studies University of Newcastle, UK.
  More Information

No publications provided by British Thoracic Society

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00376662     History of Changes
Other Study ID Numbers: BTS HRT and Etidronate Study
Study First Received: September 13, 2006
Last Updated: September 13, 2006
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by British Thoracic Society:
HRT
Etidronate
Fractures
 Osteoporosis
Asthma
Glucocorticoids

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Etidronic Acid
Glucocorticoids
 Hormones
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on June 18, 2013