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

Osteoporosis Clinical Trial

Official title:

Clinical Results of Bisphosphonate and Denosumab Therapy Following Teriparatide Therapy for Japanese, Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02166437
• Other study ID #: IRB TH No 6-3
• Status: Recruiting
• Phase: N/A
• First received: June 15, 2014
• Last updated: October 18, 2016
• Start date: November 2013
• Est. completion date: November 2018

Study information

• Verified date: October 2016
• Source: Tomidahama Hospital
• Contact: Rui Niimi, MD, PhD
• Phone: (81)-59-365-0023
• Email: furikakefuri[@]hotmail.co.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• severe osteoporotic patients

Exclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis

Locations

Country	Name	City	State
Japan	Tomidahama Hospital	Yokkaichi	Mie

Sponsors (1)

Lead Sponsor	Collaborator
Tomidahama Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical results of bisphosphonate vs. denosmab following daily teriparatide treatment	The investigators plan to analyze 500 patients who treated with bisphosphonate or denosmab following daily teriparatide treatment.; We investigate changes in BMD and bone turnover markers.	Up to 36 months	Yes