Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol.

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine wich treatment is the most effective in prevention of glucocorticoid-induced osteoporosis in patients with rheumatic diseases. The STOP-study: a randomized placebo controlled trial with alendronate versus alfacalcidol.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Collaborator: Dutch Health Care Insurance Board
• Treatments: Alendronate; Alfacalcidol; Glucocorticoids; Hydroxycholecalciferols; Vitamin D

Criteria

Inclusion Criteria:

• Patients with a rheumatic disease.

• Starting treatment with glucocorticoids in a dosage of 7.5 mg prednisone equivalent daily or higher.

• All ethnic groups and races.

Exclusion Criteria:

• Glucocorticoid treatment in the past 12 months (except for 12 weeks preceding the study)

• Primary hyperparathyroidism, hyperthyroidism or hypothyroidism in last year

• Metabolic bone disease

• Creatinine clearance of < 50 ml/min

• Documented hypercalcemia or hypercalciuria, nephrolithiasis in the last 5 years

• Pregnancy or lactation

• Treatment in the last 12 months with hormone-replacement therapy

• Anabolic steroids, calcitonin, active vitamin D3 analogues, fluoride or bisphosphonates.