Examination for the effect of combination therapy with alendronate and eldecalcitol in primary osteoporotic patients :A randomized active comparator study -Switch from alfacalcidol to eldecalcitol-

Examination for the effect of combination therapy with alendronate and eldecalcitol in primary osteoporotic patients :A randomized active comparator study -Switch from alfacalcidol to eldecalcitol- - Examination for the effect of combination therapy with alendronate and eldecalcitol for osteoporosis -Switch from alfacalcidol to eldecalcitol-

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006964

Enrollment

120

Registered

2011-12-27

Start date

2012-01-01

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

Osteoporosis

Interventions

Alendronate (35mg/week) + alfacalcidol (1.0ug/day) for 48 weeks Alendronate (35mg/week) + eldecalcitol (0.75ug/day) for 48 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Primary osteoporotic patients (2) Patients who are treated with alendronate and alfacalcidol for more than 24 weeks and less than five years (3) Patients with informed of consent

Exclusion criteria

Exclusion criteria: (1) Patients who are diagnosed as contraindication of alendronate treatments (2) Patients who are diagnosed as contraindication of eldecalcitol treatments (3) Patients who are treated with glucocorticoid (4) Patients who have serum calcium levels of above 10.5mg/dL (5) Patients who have taken osteoporosis treatments other than alendronate and alfacalcidol (6) Patients who are inappropriate for this study by physician

Design outcomes

Primary

Measure	Time frame
Change of lumbar spine bone mineral density	—

Secondary

Measure	Time frame
Change of total hip bone mineral density Number of fracture occurred Change of bone metabolic markers Safety	—

Countries

Japan

Contacts

Public ContactYasuo Inoue

Tokyo Women's Medical University Medical Center East Department of Orthopaedic Surgery

i-yasuo2@apr.so-net.jp03-3810-1111

Outcome results

None listed

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