Glucocorticoids Promote Osteoclast Survival

• Status: Terminated
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Arkansas
• Treatments: Alendronate; Glucocorticoids; Prednisone

Criteria

Inclusion Criteria:

1. 18 years old or greater

2. agree to at least one bone biopsy

3. agree to BMD, blood and urine tests

4. receiving at least 10 mg/day of prednisone for at least three months

5. either be a candidate for alendronate or be taking alendronate (70 mg/week for at least three months)

Exclusion Criteria:

1. any metabolic bone disorder such as Paget's disease, renal osteodystrophy, parathyroid disease or osteomalacia

2. obesity enough to make a biopsy difficult

3. concurrent use of any tetracycline

4. hypercalcemia

5. kidney stones in the last two years

6. home O2

7. gastric surgery, stapling or bypass

8. inflammatory bowel disease

9. untreated thyroid disease

10. organ transplants

11. malabsorption

12. anticoagulation

13. current infection

14. serious illness

15. allergy to Demerol, Valium, iodine, tetracycline, tape

16. use of anticonvulsant drugs, heparin, Forteo, calcitonin or high-dose fluoride within the past six months