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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00138983
• Date of registration: 29/08/2005
• Prospective Registration: No
• Primary sponsor: UMC Utrecht
• Public title: Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol.
• Scientific title: Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol.
• Date of first enrolment: May 2000
• Target sample size: 200
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00138983
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

Netherlands

Contacts

• Name: J.W.J. Bijslma, Prof.
• Affiliation: UMC Utrecht

• Name: R.N.J.T.L. de Nijs, MD
• Affiliation: UMC Utrecht

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Giant Cell Arteritis

Rheumatoid Arthritis

Polymyositis

Polymyalgia Rheumatica

Wegener’s Granulomatosis

Intervention(s)

Drug: Alendronate versus alfacalcidol (1-alpha OH vitamin D)

Primary Outcome(s)

Percent change in bone mineral density of the lumbar spine (lumbar vertebrae 2 to 4) at 18 months.

Secondary Outcome(s)

Percent change in bone mineral density of the femoral neck and total hip at 18 months and incidence of morphometrical vertebral deformities, symptomatic vertebral fractures and non-vertebral fractures.

Secondary ID(s)

OG67-STOP-study

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Dutch Health Care Insurance Board