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Clinical Results of Bisphosphonate and Denosumab Therapy Following Teriparatide Therapy for Japanese

T

Tomidahama Hospital

Status

Unknown

Conditions

Osteoporosis

Study type

Observational

Funder types

Other

Identifiers

NCT02166437
IRB TH No 6-3

Details and patient eligibility

About

In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of bisphosphonate and denosumab randomly divided following daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.

Full description

Registry criteria: Patients treated in the investigators hospital using teriparatide. Enrolled patients are severe osteoporosis; more than two previous osteoporotic fractures, low BMD (< young adult mean 65%).

Interventions: blood analyses and dual-energy X-ray absorptiometry (DXA) every 4 months Informed consent: Written informed consent will be obtained. Sample size: Five-hundreds participants

Enrollment

500 estimated patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • severe osteoporotic patients

Exclusion criteria

  • cancer, hypercalcemia, etc (i.e. patients who could not use bisphosphonate, denosmab, teriparatide)

Trial design

500 participants in 3 patient groups

Alendronate
Description:
Patients treated with alendronate
Minodronate
Description:
Patients treated with minodronate
Denosmab
Description:
Patients treated with denosmab

Trial contacts and locations

1

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Central trial contact

Rui Niimi, MD, PhD

Data sourced from clinicaltrials.gov

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