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Effects of Denosumab Therapy for Japanese

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ClinicalTrials.gov Identifier: NCT02491515
Recruitment Status : Recruiting
First Posted : July 8, 2015
Last Update Posted : November 25, 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 denosumab in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.

The main objective of this study is to investigate effects of denosumab. The researchers also investigate the effects of Effects of previous osteoporotic therapy to denosumab treatment. In this study, the investigators analyse the determinants of subsequent BMD increase and fracture preventing effect by teriparatide.


Condition or disease Intervention/treatment
Osteoporosis Drug: Denosumab

Detailed Description:

Registry criteria: Patients treated in the investigators hospital using denosumab. 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: Effects of Denosumab Therapy for Japanese Osteoporotic Patients
Study Start Date : July 2012
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
Drug Information available for: Denosumab


Intervention Details:
  • Drug: Denosumab
    every 6 month injection
    Other Name: Prolia


Primary Outcome Measures :
  1. BMD increase by denosumab in Japanese [ Time Frame: Up to 48 months ]
    The investigators evaluate BMD increase by denosmab in Japanese patients.


Secondary Outcome Measures :
  1. The determinants related to BMD increase and fracture prevention for denosumab treatment [ Time Frame: Up to 48 months ]
    The investigators evaluated lumbar and femoral neck BMD. The investigators evaluated baseline patients characteristics. The investigators will evaluate the relationship between BMD increase or fracture and patients characteristics using univariate and multivariate analysis.

  2. Effects of previous therapy to denosumab [ Time Frame: Up to 48 months ]
    The investigators evaluate effects of previous osteoporosis treatment to denosumab in BMD increase and bone turnover marker response using univariate and multivariate analysis.



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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:

  • Osteoporotic patients

Exclusion Criteria:

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

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): NCT02491515


Contacts
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Contact: Rui Niimi, MD +81593650023 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 Tomidahama Hospital

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Responsible Party: Toshihiko Kono, Head of Hospital, Tomidahama Hospital
ClinicalTrials.gov Identifier: NCT02491515     History of Changes
Other Study ID Numbers: IRB9-2
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016

Keywords provided by Toshihiko Kono, Tomidahama Hospital:
Osteoporosis
BMD
denosumab
previous therapy

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