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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

1992-08-31

Study Completion Date

2000-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteoporosis

Keywords

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HRT Etidronate Fractures Osteoporosis Asthma Glucocorticoids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Hormone Replacement Therapy and Etidronate

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

0 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Roger M Francis, MD

Role: STUDY_DIRECTOR

School of Clinical Medical Studies University of Newcastle, UK.

Locations

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Department of Chest Medicine, Llandough Hospital

Cardiff, Wales, United Kingdom

Site Status

Department of Chest Medicine, Llandough Hospital,

Cardiff, Wales, United Kingdom

Site Status

Countries

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United Kingdom

References

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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. doi: 10.1258/rsmsmj.54.1.21.

Reference Type DERIVED

PMID: 19291931 (View on PubMed)

Other Identifiers

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BTS HRT and Etidronate Study

Identifier Type: -

Identifier Source: org_study_id