TeriGo Study

Not Applicable

• Conditions: Glucocorticoid-induced Osteoporosis

• Registration Number: JPRN-jRCTs031180311
• Lead Sponsor: anki Toshihiro

Brief Summary

As primary outcomes, changes in lumbar and femur BMD for 72 weeks did not show significant difference between bisphosphonates and teriparatide with PPS. In ITT analysis, teriparatide treatment group showed significant increase in lumbar (especially in L1 and L2) BMD compared to bisphosphonates treatment group. Even though with the small sample size, switching to teriparatide showed the tendency to improve BMD compared with continuing bisphosphonates.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-15
• Study Completion: 2021-05-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1) Age at 20 yaers old or more.
Paitnets who recieve glucocorticoid (PSL 5mg or more) and bisphosphonate more than 6 months.
2) BMD of lumber spine (L1-4) or hip (neck or total) by DEXA is T-score of -2.0 or less, or T-score of -1.0 or less who have a history of fragility fracture.
3) Written informed consent required.

Exclusion Criteria

1) Patients whose BMD of 3 or more of lumbar spines cannot be analysed because of fracture or artificial materials.
2) Contraindication for bisphosphonate or teriparatide.
3) Patients who have received teriparatide or denosumab.
4) Patients with active infection or malignancy.
5) Age less than 20 years old.
6) Patients who is currently pregnant, breastfeeding or willing to get pregnant.
7) Patients who do not give consent to the study.
8) Patients who are judged to be inappropriate by the physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the change of bone mineral density in hip and lumbar spine (L1-4).

Secondary Outcome Measures

Name	Time	Method
1)The change of bone mineral density in hip and lumbar spine at week 144.<br>2)The change of bone mineral density in hip (neck and trochanter) at week 72.<br>3)The change of bone mineral density in hip and lumbar spine at week 24, 48, and 108.<br>4)Fracture of thoracic and lumbar spine at week 24, 48, 72, 108 and 144.<br>5)Serum osteocalcin and TRAP-5b and urine NTX at week 24, 48, 72, 108 and 144.<br>6)Fragility fracture at week 24, 48, 72, 108 and 144.<br>7)Adverse events.