TeriGo Study

JRCT ID: jRCTs031180311

Registered date:15/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Glucocorticoid-induced Osteoporosis
• Date of first enrollment: 06/08/2016
• Target sample size: 50
• Study type: Interventional

Intervention(s)

Teriparatide arm: Patients receive weekly teriparatide with a discontinuation of bisphosphonate. At week 72, patients stop receiving teriparatide and are switched back to bisphosphonate. At week 144, final observation is performed.
Bisphosphonate arm: Patients continue to receive residual bisphosphonate until week 144.

Outcome(s)

• Primary Outcome: The primary outcome is the change of bone mineral density in hip and lumbar spine (L1-4).

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Nanki Toshihiro
• Source(s) of Monetary Support: Teikyo Academic Research Center
• Secondary ID(s): UMIN000021987