Effects of Teriparatide Therapy for Japanese

Osteoporosis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01956461
• Other study ID #: IRB TH No 6
• Status: Recruiting
• Phase: N/A
• First received: September 21, 2013
• Last updated: October 18, 2016
• Start date: September 2010
• Est. completion date: October 2017

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 [Patient Registry]

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 daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.

Several determinants were reported to be related to subsequent BMD increase, such as baseline bone turnover markers (BTMs), low BMD at baseline, age, prior treatment, but comprehensive discussion is lacking. Specifically, there analyses were performed fragmentarily.

The main objective of this study is to reveal the determinants of subsequent BMD increase and fracture preventing effect by teriparatide.

Next, in Japan, as the baby boom generation retires, aging and depopulation occur rapidly. As a result, there is a lot of nursing home. But there are few reports concerning to the efficacy of teriparatide treatment in nursing home patients. The second objective is to reveal the efficacy of teriparatide for patients living nursing home, especially BMD changes, bone turnover makers change, and adverse events.

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: October 2017
• Est. primary completion date: November 2016
• 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 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	The determinants related to BMD increase and fracture prevention for teriparatide treatment	The investigators plan to analyze 500 patients who undergo teriparatide treatments 12 months. To enroll 500 participants, up to 24 months is required beside 12 months treatment periods.; We investigate several determinants related to BMD increase, such as baseline age, gender, body mass index, BMD, BTMs, history of fracture, and prior treatment. We also investigate determinants related to fracture prevention effects by teriparatide treatment, such as baseline age, gender, body mass index, BMD, BTMs, history of fracture, prior treatment, walking ability, dementia,and site of living.; To determine the response variables of BMD changes and fracture prevention effects, initially univariate analyses are performed by Spearman correlation coefficients and Mann-Whitney U test. Data are further analyzed with a multiple regression. To estimate odds ratios and 95% confidence intervals (95% CIs) of each determinants, logistic regression analyses are performed.	Up to 36 months	Yes
Secondary	BMD and BTMs response, and fracture prevention effects of teriparatide for the patients in nursing home	We plan to evaluate longitudinal BMD and BTMs changes for 24 months. BMD was evaluated every four months, ans BTMs are evaluated one months after treatment, and every four months. Fracture prevention effects are evaluated by radiography, if fracture is suspected. Statical analyses are performed using Spearman correlation coefficients, paired t-test, Mann-Whitney U test, and Kaplan-Meier method.	Oct 2014	Yes