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

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Brief Title

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

Official Title

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

Brief 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.
    

Detailed 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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 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.

Condition

Rheumatoid Arthritis

Intervention

Alendronate versus alfacalcidol (1-alpha OH vitamin D)


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

200

Start Date

May 2000

Completion Date

November 2003


Eligibility 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.
      

Gender

All

Ages

18 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

J.W.J. Bijslma, Prof., , 

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT00138983

Organization ID

OG67-STOP-study



Study Sponsor

UMC Utrecht

Collaborators

 Dutch Health Care Insurance Board

Study Sponsor

J.W.J. Bijslma, Prof., Principal Investigator, UMC Utrecht


Verification Date

March 2000