Effects of Teriparatide Therapy for Japanese

NCT01956461 | Unknown

• 1 other identifier: IRB TH No 6
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis

Keywords

osteoporosis; BMD; teriparatide; nursing home

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• BMD and BTMs response, and fracture prevention effects of teriparatide for the patients in nursing home

  Oct 2014

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Osteoporotic patients who admit to our hospital

You may qualify if:

• severe osteoporotic patients

You may not qualify if:

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

Sponsors & Collaborators

• Tomidahama Hospital: lead

Study Sites (1)

Tomidahama Hospital

Yokkaichi, Mie-ken, 510-8008, Japan

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Rui Niimi, MD, PhD

CONTACT

(81)-59-365-0023; furikakefuri@hotmail.co.jp

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hospital

Study Record Dates

• First Submitted: September 21, 2013
• First Posted: October 8, 2013
• Study Start: September 1, 2010
• Primary Completion: November 1, 2016
• Study Completion: October 1, 2017
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

JP (1)