The additive effect of Eldecalcitol for glucocorticoid induced osteoporosis responding poorly to Alendronate.

The additive effect of Eldecalcitol for glucocorticoid induced osteoporosis responding poorly to Alendronate. - The additive effect of Eldecalcitol for glucocorticoid induced osteoporosis responding poorly to Alendronate.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009586

Enrollment

Registered

2012-12-20

Start date

2012-10-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glucocorticoid induced osteoporosis

Interventions

Alendronate (35mg/week) Alendronate (35mg/week) + Eldecalcitol (0.75mcg/day)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Glucocorticoid induced osteoporosis patients who satisfy one of any conditions as follows : A: patients whose lumbar spine or total hip BMD have not reached %YAM80 within 4 months. B: patients who have taken 5mg or more prednisolone per day. C: patients whose bone turnover markers have been beyond normal ranges. D: patients whose lumbar spine or total hip BMD have had negative change within 1 year. E: patients who have experienced at least an incident fracture while on bisphosphonates therapy 2. Patients with informed of consent.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindication for Eldecalcitol treatments 2. Patients who are inappropriate for this study by physicians.

Design outcomes

Primary

Measure	Time frame
Change from baseline to 12 months in lumbar spine BMD	—

Secondary

Measure	Time frame
Change from baseline to 12 months in total hip BMD bone turnover markers (TRACP-5b,uNTX, BAP, intact PTH, whole PTH, Sclerostin, OC, ucOC) incidence of fracture (vertebral fractures, non- vertebral fractures), blood calcium urinary calcium creatinine	—

Countries

Japan

Contacts

Public ContactTsuji Goh

Shinko Hospital Department of Rheumatic Disease

tsuji_goh@shinkohp.or.jp078-2661-6711

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026