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Clinical Results of Bisphosphonate and Denosumab Therapy Following Teriparatide Therapy for Japanese

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02166437
Recruitment Status : Unknown
Verified October 2016 by Toshihiko Kono, Tomidahama Hospital.
Recruitment status was:  Recruiting
First Posted : June 18, 2014
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 bisphosphonate and denosumab randomly divided following daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.

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

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Results of Bisphosphonate and Denosumab Therapy Following Teriparatide Therapy for Japanese, Prospective Study
Study Start Date : November 2013
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Group/Cohort
Alendronate
Patients treated with alendronate
Minodronate
Patients treated with minodronate
Denosmab
Patients treated with denosmab



Primary Outcome Measures :
  1. Clinical results of bisphosphonate vs. denosmab following daily teriparatide treatment [ Time Frame: Up to 36 months ]

    The investigators plan to analyze 500 patients who treated with bisphosphonate or denosmab following daily teriparatide treatment.

    We investigate changes in BMD and bone turnover markers.




Information from the National Library of Medicine

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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
tion 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 bisphosphonate, denosmab, 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): NCT02166437


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

Locations
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Japan
Tomidahama Hospital Recruiting
Yokkaichi, Mie, Japan, 510-8008
Contact: Rui Niimi, MD, PhD    (81)-59-365-0023    furikakefuri@hotmail.co.jp   
Principal Investigator: Rui Niimi, MD, PhD         
Sponsors and Collaborators
Tomidahama Hospital
Investigators
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Study Director: Rui Niimi, MD, PhD Tomidahama Hospital
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Responsible Party: Toshihiko Kono, Head of Hospital, Tomidahama Hospital
ClinicalTrials.gov Identifier: NCT02166437    
Other Study ID Numbers: IRB TH No 6-3
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016
Keywords provided by Toshihiko Kono, Tomidahama Hospital:
osteoporosis
BMD
teriparatide
bisphosphonate
denosmab
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases