Eldeacalcitol Phase IV study; combination therapy with alendronate

The post-marketing clinical randomized study of the comparison of combined Eldecalcitol with alendronate sodium hydrate and alendronate sodium hydrate alone for primary osteoporosis patient.

Status

Unknown

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080221612

Enrollment

200

Registered

2011-10-11

Start date

2011-10-11

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

Primary Osteoporosis

Interventions

investigational material(s) Generic name etc : Eldecalcitol INN of investigational material : Therapeutic category code : 311 Vitamin A, D and preparations Dosage and Administration for Investigation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The patients with primary osteoporosis diagnosed in accordance with the diagnostic criteria for osteoporosis published by the Japanese Society for Bone and Mineral Research (2000 revised edition)

Exclusion criteria

Exclusion criteria: -The patients who have been treated with a Bisphosphonate within 48 weeks before the start of treatment. -The patients who have been treated with medications that affect bone turnover, excluding calcium products -The Other disease which presents a low bone mass

Design outcomes

Primary

Measure	Time frame
Percentage changes in lumbar bone mineral densities DXA(dual x-ray absorptiometry)	—

Secondary

Measure	Time frame
Percentage changes in femoral bone mineral density and the bone turnover marker X-ray and laboratory test values	—

Outcome results

None listed

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