Back to resultsHRT Versus Etidronate for Osteoporosis and Fractures in Asthmatics Receiving Glucocorticoids.
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Hormone Replacement Therapy and Etidronate
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring HRT, Etidronate, Fractures, Osteoporosis, Asthma, Glucocorticoids
Eligibility 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.
Sites / Locations
- Department of Chest Medicine, Llandough Hospital
- Department of Chest Medicine, Llandough Hospital,
Outcomes
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
Full Information
NCT ID
NCT00376662
First Posted
September 13, 2006
Last Updated
September 13, 2006
Sponsor
British Thoracic Society
1. Study Identification
Unique Protocol Identification Number
NCT00376662
Brief Title
HRT Versus Etidronate for Osteoporosis and Fractures in Asthmatics Receiving Glucocorticoids.
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
August 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
British Thoracic Society
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
HRT, Etidronate, Fractures, Osteoporosis, Asthma, Glucocorticoids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
750 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Hormone Replacement Therapy and Etidronate
Primary Outcome Measure Information:
Title
New symptomatic fractures, new or worsening morphometric fractures of the throaco-lumbar spine, and changes in bone mineral density.
Secondary Outcome Measure Information:
Title
Unwanted effects
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger M Francis, MD
Organizational Affiliation
School of Clinical Medical Studies University of Newcastle, UK.
Official's Role
Study Director
Facility Information:
Facility Name
Department of Chest Medicine, Llandough Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF62 2XX
Country
United Kingdom
Facility Name
Department of Chest Medicine, Llandough Hospital,
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF64 2XX
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19291931
Citation
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.
Results Reference
derived
Learn more about this trial
HRT Versus Etidronate for Osteoporosis and Fractures in Asthmatics Receiving Glucocorticoids.
We'll reach out to this number within 24 hrs