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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00376662

Enrollment

750

Registered

2006-09-15

Start date

1992-08-31

Completion date

2000-10-31

Last updated

2006-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

HRT, Etidronate, Fractures, Osteoporosis, Asthma, Glucocorticoids

Brief 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.

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.

Interventions

DRUGHormone Replacement Therapy and Etidronate

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

0 Years to 59 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
New symptomatic fractures, new or worsening morphometric fractures of the throaco-lumbar spine, and changes in bone mineral density.	—

Secondary

Measure	Time frame
Unwanted effects	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026