Comparison of usefulness between denosumab and alendronate after teriparatide therapy in patients with glucocorticoid-induced osteoporosis (GIOP)

Phase 4

Recruiting

• Conditions: glucocorticoid-induced osteoporosis (GIOP)

• Registration Number: JPRN-UMIN000014570
• Lead Sponsor: Saitama Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-16
• Study Completion: 2019-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patients who have serious renal disorder (eGFR<35ml/min or Cr>1.5mg/ml) 2)Patient who has a history of renal stone past 5 years 3)Patients with primary or secondary hyperparathyroidism 4)Patients with hyperthyroidism or hypothyroidism 5)Patients who are considered to be contraindicated for bisphosphonates or denosumab 6)Patients who are treated with warfarin or digitalis 7)Patients who have newly received drugs having influence on bone remodeling within 6 months at inclusion of the study (estriol, estradiol, Vitamin D3, Vitamin K2, SERM(Raloxifene, bazedoxifene), Calcitonin, Ipriflavone, Steroids) 8)Patients who had received bisphosphonates during teriparatide therapy 9) Patients who are thought to be inappropriate for this study by physician

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 3 years of this study.

Secondary Outcome Measures

Name	Time	Method
on symptomatic vertebral fractures and non-vertebral fractures deetermined by plain X-ray. Bone mineral density values, those are measured at the lumbar spine. The serum levels of NTX, osteocalcin, 25(OH)vitamin D, etc.