Effect of etidronate therapy on prevention of fracture, bone mineral density and bone turnover markers in osteoporotic patients with severe motor and intellectual disabilities: a randomized controlled trial

Effect of etidronate therapy on prevention of fracture, bone mineral density and bone turnover markers in osteoporotic patients with severe motor and intellectual disabilities: a randomized controlled trial - EOSMID

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010689

Enrollment

500

Registered

2013-05-10

Start date

2010-01-04

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

Patients without history of fragile fracture for the past 5 years. Repeated administration of etidronate (200mg) for 2 weeks, following a cessation for 10 weeks. Patients without history of fragile

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with osteoporosis (BMD: less than 70% of YAM) 2. Patients with severe motor and intellectual disabilities (Ohshima's classification: 1,2,3,4) 3. Patients with informed of consent obtained from a parent or other family member.

Exclusion criteria

Exclusion criteria: 1. Patients with other diseases presenting low BMD 2. Patients with GERD

Design outcomes

Primary

Measure	Time frame
occurrence of fragile fracture	—

Secondary

Measure	Time frame
changes of bone mineral density (L2-4) and bone turnover markers (serum TRAP-5b, serum NTX, serum BAP)	—

Countries

Japan

Contacts

Public ContactShigenori Yamamoto

NHO Shimoshizu National Hospital Pediatrics

syamamoto3@nifty.com043-422-2511

Outcome results

None listed

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