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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00376662
• Other study ID #: BTS HRT and Etidronate Study
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2006
• Last updated: September 13, 2006
• Start date: August 1992
• Est. completion date: October 2000

Study information

• Verified date: September 2006
• Source: British Thoracic Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: October 2000
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 59 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Hormone Replacement Therapy and Etidronate

Locations

Country	Name	City	State
United Kingdom	Department of Chest Medicine, Llandough Hospital	Cardiff	Wales
United Kingdom	Department of Chest Medicine, Llandough Hospital,	Cardiff	Wales

Sponsors (1)

Lead Sponsor	Collaborator
British Thoracic Society

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New symptomatic fractures, new or worsening morphometric fractures of the throaco-lumbar spine, and changes in bone mineral density.
Secondary	Unwanted effects