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Effects of Teriparatide Therapy for Japanese

Information source: Tomidahama Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Phase: N/A

Status: Recruiting

Sponsored by: Tomidahama Hospital

Overall contact:
Rui Niimi, MD, PhD, Phone: (81)-59-365-0023, Email: furikakefuri@hotmail.co.jp

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.

Clinical Details

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: The determinants related to BMD increase and fracture prevention for teriparatide treatment

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

Detailed 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

Eligibility

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- severe osteoporotic patients

Exclusion Criteria:

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

Locations and Contacts

Rui Niimi, MD, PhD, Phone: (81)-59-365-0023, Email: furikakefuri@hotmail.co.jp

Tomidahama Hospital, Yokkaichi, Mie 510-8008, Japan; Recruiting
Rui Niimi, MD, PhD, Phone: (81)-59-365-0023, Email: furikakefuri@hotmail.co.jp
Additional Information

Starting date: September 2010
Last updated: November 26, 2014

Page last updated: August 20, 2015

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