Effects of Eldecalcitol and Raloxifene on the suppression of new vertebral fracture with osteoporosis in perimenopausal women or ovariectomy patients: Randomized controlled trial

Effects of Eldecalcitol and Raloxifene on the suppression of new vertebral fracture with osteoporosis in perimenopausal women or ovariectomy patients: Randomized controlled trial - Effects of Eldecalcitol and Raloxifene on the suppression of new vertebral fracture with osteoporosis in perimenopausal women or ovariectomy patients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009378

Enrollment

360

Registered

2012-11-21

Start date

2012-10-02

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 in perimenopausal women or ovariectomy patients

Interventions

Eldecalcitol (0.75&amp

micro

g/cap.): once a day for 36months Raloxifene (60mg/Tab.): once a day for 36months

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Women selected according to the diagnostic criteria for osteoporosis based on Japanese Guideline for the prevention and treatment of Osteoporosis -up dated 2011-

Exclusion criteria

Exclusion criteria: 1,If the disease has progressed apparently. 2,If the patient is no longer any reason to visit. 3,Others, If the patient wishes to have the discontinuation of treatment with this protocol. or If the doctor determines that difficult to continue treatment with this protocol.

Design outcomes

Primary

Measure	Time frame
The primary end point is incident of new vertebral fractures.	—

Secondary

Measure	Time frame
The secondary end points included the changes in bone mineral density of lumbar spine (L2-L4 BMD) and changes in bone turnover markers (tartrate resistant acid phosphatase-5b (TRACP5b), bone-alkaline phosphatase (BAP)).	—

Countries

Japan

Contacts

Public ContactYasuo Hirai

Tokyo Women's Medical University Hospital Department of Obstetrics and Gynecology

yhirai-ind@umin.ac.jp

Outcome results

None listed

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