Glucocorticoids Promote Osteoclast Survival
Information source: University of Arkansas
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: alendronate (Drug)
Phase: N/A
Status: Terminated
Sponsored by: University of Arkansas Official(s) and/or principal investigator(s):
Jimmie L Valentine, Study Chair, Affiliation: IRB at UAMS
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.
Clinical Details
Official title: Glucocorticoids Promote Osteoclast Survival
Study design: Observational Model: Case Control, Time Perspective: Prospective
Detailed description:
Aminobisphosphonates are extensively used to prevent fractures in patients with osteoporosis
(1-6). Treatment with these drugs leads to decreases in bone resorption and biochemical
markers of bone turnover and progressive increases in bone mineral density (BMD). The
increase in BMD in response to bisphosphonate therapy in glucocorticoid-treated patients is,
however, less than half that measured in women and men with osteoporosis unrelated to
glucocorticoid drugs even though the patients with osteoporosis are usually older. The goal
of this objective is to determine the contribution of increased osteoclast survival to the
diminished response to bisphosphonate therapy in patients receiving excess glucocorticoids
compared to patients with osteoporosis.
1. Liberman U, Weiss SR, Broll J, et al. Effect of oral alendronate on bone mineral
density and the incidence of fractures in postmenopausal osteoporosis. N Engl J Med
1995;333: 1437-1443.
2. Bone HG, Downs RW, Tucci JR, et al. Dose-response relationships for alendronate
treatment in osteoporotic elderly women. J Clin Endocrinol Metab 1997;82: 265-274.
3. McClung M, Clemmesen B, Daifotis A, et al. Alendronate prevents postmenopausal bone
loss in women without osteoporosis. Ann Intern Med 1998;128: 253-261.
4. Recker RR, Weinstein RS, Chestnut CH III, et al. Histomorphometric evaluation of daily
and intermittent oral ibandronate in women with postmenopausal osteoporosis: results
from the BONE study. Osteoporosis Int 2004;15: 231-237.
5. Saag KG, Emkey R, Schnitzer TJ, et al. Alendronate for the prevention and treatment of
glucocorticoid-induced osteoporosis. Glucocorticoid-Induced Osteoporosis Intervention
Study Group. N Engl J Med 1998;339: 292-299.
6. Orwoll E, Ettinger M, Weiss S, et al. Alendronate for the treatment of osteoporosis in
men. N Engl J Med 2000;343: 604-610.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
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
Locations and Contacts
University of Arkansas hospitals and clinics and the Central Arkansas Veterans Healthcare System, Little Rock, Arkansas 72205, United States
Additional Information
Starting date: January 2004
Last updated: August 29, 2011
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