Study Stopped
Terminated due to recruitment problems
Glucocorticoids Promote Osteoclast Survival
2 other identifiers
observational
3
1 country
1
Brief Summary
The purpose of this study is to determine the difference in response to bisphosphonate therapy in patients receiving excess glucocorticoids compared to patients with postmenopausal or male osteoporosis. Bisphosphonates are approved by the FDA for the treatment of postmenopausal women and osteoporotic men who are at high risk of fracture and in men and women with excess glucocorticoid administration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2004
Longer than P75 for all trials
1 active site
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
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 11, 2007
CompletedFirst Posted
Study publicly available on registry
December 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedAugust 30, 2011
August 1, 2011
6.3 years
December 11, 2007
August 29, 2011
Conditions
Keywords
Study Arms (2)
glucocorticoids
patients receiving glucocorticoid treatment
glucocorticoids and bisphosphonates
patients receiving both glucocorticoids and bisphosphonates
Interventions
70 mg of alendronate orally per week for at least three months in patients receiving at least 10 mg/day or oral prednisone for at least three months
Eligibility Criteria
adults receiving aminobisphosphonate therapy to prevent osteoporosis from glucocorticoids, postmenopausal bone loss or osteoporosis in males
You may qualify if:
- years old or greater
- agree to at least one bone biopsy
- agree to BMD, blood and urine tests
- receiving at least 10 mg/day of prednisone for at least three months
- either be a candidate for alendronate or be taking alendronate (70 mg/week for at least three months)
You may not qualify if:
- any metabolic bone disorder such as Paget's disease, renal osteodystrophy, parathyroid disease or osteomalacia
- obesity enough to make a biopsy difficult
- concurrent use of any tetracycline
- hypercalcemia
- kidney stones in the last two years
- home O2
- gastric surgery, stapling or bypass
- inflammatory bowel disease
- untreated thyroid disease
- organ transplants
- malabsorption
- anticoagulation
- current infection
- serious illness
- allergy to Demerol, Valium, iodine, tetracycline, tape
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arkansas hospitals and clinics and the Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205, United States
Biospecimen
bone biopsy specimens
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jimmie L Valentine
IRB at UAMS
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2007
First Posted
December 13, 2007
Study Start
January 1, 2004
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
August 30, 2011
Record last verified: 2011-08