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Effects of Teriparatide Therapy for Japanese

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ClinicalTrials.gov Identifier: NCT01956461
Recruitment Status : Unknown
Verified October 2016 by Toshihiko Kono, Tomidahama Hospital.
Recruitment status was:  Recruiting
First Posted : October 8, 2013
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Toshihiko Kono, Tomidahama Hospital

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.


Condition or disease
Osteoporosis

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


Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Study Start Date : September 2010
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The determinants related to BMD increase and fracture prevention for teriparatide treatment [ Time Frame: Up to 36 months ]

    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.



Secondary Outcome Measures :
  1. BMD and BTMs response, and fracture prevention effects of teriparatide for the patients in nursing home [ Time Frame: Oct 2014 ]
    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.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Osteoporotic patients who admit to our hospital
Criteria

Inclusion Criteria:

  • severe osteoporotic patients

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956461


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

Locations
Japan
Tomidahama Hospital Recruiting
Yokkaichi, Mie, Japan, 510-8008
Contact: Rui Niimi, MD, PhD    (81)-59-365-0023    furikakefuri@hotmail.co.jp   
Sponsors and Collaborators
Tomidahama Hospital

Responsible Party: Toshihiko Kono, Head of Hospital, Tomidahama Hospital
ClinicalTrials.gov Identifier: NCT01956461     History of Changes
Other Study ID Numbers: IRB TH No 6
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016

Keywords provided by Toshihiko Kono, Tomidahama Hospital:
osteoporosis
BMD
teriparatide
nursing home

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs