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Prevention of incident fracture of Osteoporosis in Japan(Multi-center Randomized Trial with Risedronate and VitaminK2)

Prevention of incident fracture of Osteoporosis in Japan(Multi-center Randomized Trial with Risedronate and VitaminK2) - Japanese Osteoporosis Intervention Trial -03 (JOINT-03)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000991
Enrollment
1820
Registered
2008-02-01
Start date
2008-01-01
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

Risedronate(2 years) Risedronate +vitaminK2(2 years)

Sponsors

Japan Osteoporosis Society/A-TOP consortium
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Criteria for initiation of pharmacotherapy to prevent fragility fracture(Japanese Guidelines for the prevention and treatment of osteoporosis 2006 edition) 2.Age>=65 years old(female) 3.Risk factor number for incident fracture>=1(in A-TOP research group) 4.Possible to walk alone 5.Possible to answer QOL questionnaire

Exclusion criteria

Exclusion criteria: 1.Using warfarin 2.Secondary osteoporosis and low bone mass disease except osteoporosis 3.Having contraindication in using drugs 4.Hypothyroidism and hyperparathyroidism 5.Disfunction of communication of the intention 6.Prevalent vertebral fracture>=6 7.Deformation of vertebra 8.Abnormal heart function,abnormal hepatic function,abnormal kidney function 9.Taken bisphosphonate within previous 6 months

Design outcomes

Primary

MeasureTime frame
Incident vertebral fracture rate and incident nonvertebral fracture rate

Secondary

MeasureTime frame
Bone mineral density,stature,QOL, undercarboxylated osteocalcin,safety

Countries

Japan

Contacts

Public ContactYoji Mitadera

Public health research foundation CSP-A-TOP

a-top@csp.or.jp03-5287-2638

Outcome results

None listed

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