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
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