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Glucocorticoids Promote Osteoclast Survival
This study is currently recruiting participants.
Verified by University of Arkansas, December 2008
First Received: December 11, 2007   Last Updated: December 3, 2008   History of Changes
Sponsored by: University of Arkansas
Information provided by: University of Arkansas
ClinicalTrials.gov Identifier: NCT00572299
  Purpose

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
Postmenopausal Osteoporosis
Male Osteoporosis

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Glucocorticoids Promote Osteoclast Survival

Further study details as provided by University of Arkansas:

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

bone biopsy specimens


Estimated Enrollment: 60
Study Start Date: January 2004
Estimated Study Completion Date: March 2009
Groups/Cohorts
1
2

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572299

Contacts
Contact: Robert S Weinstein, M.D. 501-686-5130 weinsteinroberts@uams.edu

Locations
United States, Arkansas
University of Arkansas hospitals and clinics and the Central Arkansas Veterans Healthcare System Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Robert S Weinstein, M.D.     501-686-5130     weinsteinroberts@uams.edu    
Principal Investigator: Robert S Weinstein, M.D.            
Sponsors and Collaborators
University of Arkansas
Investigators
Study Chair: Jimmie L Valentine IRB at UAMS
  More Information

No publications provided

Responsible Party: University of Arkansas for Medical Sciences ( Robert S. Weinstein, M.D. )
Study ID Numbers: 28727, VA Merit Review Grant
Study First Received: December 11, 2007
Last Updated: December 3, 2008
ClinicalTrials.gov Identifier: NCT00572299     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
glucocorticoids, prednisone, alendronate,osteoclasts

Study placed in the following topic categories:
Prednisone
Musculoskeletal Diseases
Alendronate
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Osteoporosis, Postmenopausal
Osteoporosis
Bone Diseases, Metabolic
Hormones
Glucocorticoids
Bone Diseases

Additional relevant MeSH terms:
Musculoskeletal Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Osteoporosis, Postmenopausal
Osteoporosis
Bone Diseases, Metabolic
Hormones
Glucocorticoids
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009