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Fracture inhibitory effect verification test of osteoporosis drug for primary osteoporosis patients at high risk of fracture

Fracture inhibitory effect verification test of osteoporosis drug for primary osteoporosis patients at high risk of fracture - A-TOP/JOINT-05

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015573
Enrollment
1000
Registered
2014-11-01
Start date
2014-11-04
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

once weekly teriparatide alendronate

Sponsors

Research committee of A-TOP
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: A document agreement of the clinical study participation is provided and intends for a patient meeting all the following standards 1.Primary osteoporosis 2.a Japanese patient 75 years or older 3.postmenopausal women 4.The patient that an independence walk is possible 5.The patient who satisfies any of the following Patient with less than in bone density 60% of YAM or less than -3.3SD The patient who has vertebral body bone fractures more than two to the fourth lumbar vertebrae from the fourth thoracic vertebra at the time of registration Patient having a bone fracture of grade 3 The patient who has the past of the proximal thighbone bone fracture

Exclusion criteria

Exclusion criteria: 1.Secondary osteoporosis 2.bone loss Disease other than osteoporosis 3.diseases that affect the strength of the vertebral body 4.hypersensitivity 5.use of contraindicated therapeutic drugs 6.severe complications such as heart disease, liver disease, renal disease 7.problem with the reliability of the interview data 8.inpatient 9.Patients treated with teriparatide in the past

Design outcomes

Primary

MeasureTime frame
Incidence of new vertebral fracture at 72 weeks

Secondary

MeasureTime frame
Incidence of new vertebral fracture and non-vertebral fracture at 72 and 120 weeks Incidence of new vertebral fracture Exacerbation of vertebral fracture incidence BMD rate of change QOL rate of change Bone structure analysis

Countries

Japan

Contacts

Public ContactYoji Mitadera

Public Health Research Foundation Comprehensive Support Project for

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

Outcome results

None listed

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