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Changes of Bone Metabolic Markers and Bone Mineral Density After Denosumab and/or Teriparatide Treatment in Japanese Osteoporotic Patients

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ClinicalTrials.gov Identifier: NCT02156960
Recruitment Status : Recruiting
First Posted : June 5, 2014
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Yukio Nakamura, Shinshu University

Brief Summary:
It has not been well known about the changes of bone metabolic markers, bone mineral density and other bone-related markers after teriparatide and/or denosumab treatment in Japanese osteoporotic patients.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Denosumab treatment in osteoporotic patients Drug: Teriparatide treatment in osteoporotic patients Drug: Denosumab and teriparatide treatment in osteoporotic patients Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : May 2014
Actual Primary Completion Date : May 2015
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Denosumab and/or teriparatide treatment
Denosumab and/or teriparatide treatment in osteoporotic patients
Drug: Denosumab treatment in osteoporotic patients
To examine the effectiveness of denosumab in osteoporotic patients

Drug: Teriparatide treatment in osteoporotic patients
To examine the effectiveness of teriparatide in osteoporotic patients

Drug: Denosumab and teriparatide treatment in osteoporotic patients
To examine the effectiveness of denosumab and teriparatide in osteoporotic patients




Primary Outcome Measures :
  1. Changes of bone mineral density [ Time Frame: every 4-6 months ]
    Bone mineral density will be examined every 4-6 months to evaluate the suitability of the drug.


Secondary Outcome Measures :
  1. Changes of bone turnover markers [ Time Frame: every 3-6 months ]
    Bone turnover markers will be examined every 3-6 months to evaluate the suitability of the drug.



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Ages Eligible for Study:   1 Year to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Osteoporotic patients

Exclusion Criteria:

  • none

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): NCT02156960


Contacts
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Contact: Yukio Nakamura, MD, PhD +81-263-37-2659 yxn14@aol.jp

Locations
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Japan
Yukio Nakamura Recruiting
Matsumoto, Nagano, Japan, 3908621
Contact: Yukio Nakamura, MD, PhD    +81-263-37-2659    yxn14@aol.jp   
Principal Investigator: Yukio Nakamura, MD, PhD         
Sponsors and Collaborators
Shinshu University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yukio Nakamura, Assistant Professor, Shinshu University
ClinicalTrials.gov Identifier: NCT02156960     History of Changes
Other Study ID Numbers: Deno-PTH2365
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents