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

UMC Utrecht

Status and phase

Completed

Phase 3

Conditions

Polymyalgia Rheumatica

Giant Cell Arteritis

Polymyositis

Wegener's Granulomatosis

Rheumatoid Arthritis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00138983

OG67-STOP-study

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.