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Glucocorticoids Promote Osteoclast Survival

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00572299
Recruitment Status : Terminated (Terminated due to recruitment problems)
First Posted : December 13, 2007
Last Update Posted : August 30, 2011
Information provided by (Responsible Party):
University of Arkansas

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.

Condition or disease Intervention/treatment
Osteoporosis Drug: alendronate

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.

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Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Glucocorticoids Promote Osteoclast Survival
Study Start Date : January 2004
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
patients receiving glucocorticoid treatment
glucocorticoids and bisphosphonates
patients receiving both glucocorticoids and bisphosphonates
Drug: alendronate
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
Other Names:
  • Fosamax
  • Prednisone

Biospecimen Retention:   Samples Without DNA
bone biopsy specimens

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
adults receiving aminobisphosphonate therapy to prevent osteoporosis from glucocorticoids, postmenopausal bone loss or osteoporosis in males

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00572299

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United States, Arkansas
University of Arkansas hospitals and clinics and the Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
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Study Chair: Jimmie L Valentine IRB at UAMS
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Responsible Party: University of Arkansas Identifier: NCT00572299    
Other Study ID Numbers: 28727
VA Merit Review Grant ( Other Grant/Funding Number: VA Merit Grant Review )
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011
Keywords provided by University of Arkansas:
glucocorticoids, prednisone, alendronate,osteoclasts
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Bone Density Conservation Agents