Combination therapy with alendronate and alphacalcidol for prevention of symptomatic vertebral fracture in elderly patients treated with high-dose glucocorticoid: a multicenter open-label randomized controlled trial.

Not Applicable

• Conditions: glucocorticoid-induced osteoporosis

• Registration Number: JPRN-UMIN000004217
• Lead Sponsor: Society for glucocorticoid-induced osteoporosis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-01
• Study Completion: 2014-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patient who was not treated for more than 6 months (except, who had symptomatic vertebral fractures). 2)Patient who has serious renal disorder (EGFR: <35ml or Cre: more than 1.5mg/ml). 3)Patient who has a history of renal stone past 5 years. 4)Patient with primary or secondary hyperparathyroidism. 5)Patient with hyperthyroidism or hypothyroidism. 6)Patients who is diagnosed as contraindication of alendronate treatements or Alfacalcidol. 7)Patient who are treated with warfarin. 8)Patient who is inappropriate for this study by physician. 9)Patient who has experiences of receiving bisphosphonate treatment within 6 months at inclusion of the study. 10)Patient who has experiences of receiving drugs having influence on bone remodeling within 6 months at inclusion of the study (Estrogen, Vitamin D, Calcitonin, Raloxifene, Ipriflavone, Vitamin K, Steroid)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptomatic vertebral fractures, those are determined by conventional thoracic and spinal radiographs in lateral and antero-posterior projections at any time during study.

Secondary Outcome Measures

Name	Time	Method
on symptomatic vertebral fractures, those are determined by conventional thoracic and spinal radiographs in lateral and antero-posterior projections at 0, 6, 12, 24 months. Bone mineral density values, those are measured at the lumbar spine on day 0 and at 6, 12, 24 months. The serum levels of NTX, osteocalcin, 25(OH)vitamin D, growth hotmone, IGF-, those are measured on days 0, 7 and at 1, 3, 6, 12 months after glucocorticoid treatment.