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NCT Number: NCT00138983

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

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.

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Key information

Conditions

Rheumatoid Arthritis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Arteritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Connective Tissue Diseases Giant Cell Arteritis Granulomatosis with Polyangiitis Immune System Diseases Joint Diseases Lung Diseases Lung Diseases, Interstitial Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases Polymyalgia Rheumatica Polymyositis Respiratory Tract Diseases Rheumatic Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Vasculitis Vascular Diseases Vasculitis Vasculitis, Central Nervous System Wegener's Granulomatosis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UMC Utrecht

Utrecht, 3584 CX, Netherlands

About this study

Treatment with glucocorticoids (GCs) is associated with bone loss initiated already early in therapy, causing increased (vertebral) fracture risk. Bone loss is caused by inhibition of bone formation by GCs. Active vitamin D analogues like alfacalcidol directly stimulate osteoblasts leading to an increase in bone formation. Bisphosphonates like alendronate induce apoptosis of osteoclasts leading to inhibition of bone resorption.

We performed a randomized, double-placebo, double-blind clinical trial of 18 months duration in patients with a rheumatic disease, starting GCs in a dosage of 7.5 mg prednisone equivalent daily or higher. Two hundred one patients were allocated to receive either alendronate 10 mg and alfacalcidol-placebo daily or alfacalcidol 1 microgram and alendronate-placebo daily. Primary outcome was change in bone mineral density of the lumbar spine in 18 months, secondary outcome incidence of (symptomatic) morphometric vertebral deformities.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alendronate versus alfacalcidol (1-alpha OH vitamin D)

Drug

Primary outcomes

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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Dutch Health Care Insurance Board

Registry information

Official study title

Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol.

Important dates

Study start
2000
Study completion
2003
First posted
Aug 30, 2005
Registry last updated
Nov 29, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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