NCT00376662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 1992

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1992

Completed
8.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2000

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2006

Completed
Last Updated

September 15, 2006

Status Verified

September 1, 2006

First QC Date

September 13, 2006

Last Update Submit

September 13, 2006

Conditions

Osteoporosis

Keywords

HRTEtidronateFracturesOsteoporosisAsthmaGlucocorticoids

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Unwanted effects

Interventions

Hormone Replacement Therapy and EtidronateDRUG

Eligibility Criteria

Age0 Years - 59 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Postmenopausal, asthmatic outpatients under 60 years of age on long-term oral or inhaled glucocorticoid treatment for at least one year.

You may not qualify if:

  • Hysterectomy, history of breast or endometrial cancer, undiagnosed pelvic or breast mass, untreated hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Chest Medicine, Llandough Hospital

Cardiff, Wales, CF62 2XX, United Kingdom

Location

Department of Chest Medicine, Llandough Hospital,

Cardiff, Wales, CF64 2XX, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 19291931DERIVED

MeSH Terms

Conditions

OsteoporosisFractures, BoneAsthma

Interventions

Hormone Replacement TherapyEtidronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesWounds and InjuriesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Roger M Francis, MD

    School of Clinical Medical Studies University of Newcastle, UK.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2006

First Posted

September 15, 2006

Study Start

August 1, 1992

Study Completion

October 1, 2000

Last Updated

September 15, 2006

Record last verified: 2006-09

Locations

GB(2)