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