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

Primary Purpose

Osteoporosis

Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Denosumab treatment in osteoporotic patients
Teriparatide treatment in osteoporotic patients
Denosumab and teriparatide treatment in osteoporotic patients
Sponsored by
Shinshu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

1 Year - 120 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Osteoporotic patients

Exclusion Criteria:

  • none

Sites / Locations

  • Yukio NakamuraRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Denosumab and/or teriparatide treatment

Arm Description

Denosumab and/or teriparatide treatment in osteoporotic patients

Outcomes

Primary Outcome Measures

Changes of bone mineral density
Bone mineral density will be examined every 4-6 months to evaluate the suitability of the drug.

Secondary Outcome Measures

Changes of bone turnover markers
Bone turnover markers will be examined every 3-6 months to evaluate the suitability of the drug.

Full Information

First Posted
May 31, 2014
Last Updated
October 19, 2020
Sponsor
Shinshu University
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1. Study Identification

Unique Protocol Identification Number
NCT02156960
Brief Title
Changes of Bone Metabolic Markers and Bone Mineral Density After Denosumab and/or Teriparatide Treatment in Japanese Osteoporotic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shinshu University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Denosumab and/or teriparatide treatment
Arm Type
Experimental
Arm Description
Denosumab and/or teriparatide treatment in osteoporotic patients
Intervention Type
Drug
Intervention Name(s)
Denosumab treatment in osteoporotic patients
Intervention Description
To examine the effectiveness of denosumab in osteoporotic patients
Intervention Type
Drug
Intervention Name(s)
Teriparatide treatment in osteoporotic patients
Intervention Description
To examine the effectiveness of teriparatide in osteoporotic patients
Intervention Type
Drug
Intervention Name(s)
Denosumab and teriparatide treatment in osteoporotic patients
Intervention Description
To examine the effectiveness of denosumab and teriparatide in osteoporotic patients
Primary Outcome Measure Information:
Title
Changes of bone mineral density
Description
Bone mineral density will be examined every 4-6 months to evaluate the suitability of the drug.
Time Frame
every 4-6 months
Secondary Outcome Measure Information:
Title
Changes of bone turnover markers
Description
Bone turnover markers will be examined every 3-6 months to evaluate the suitability of the drug.
Time Frame
every 3-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Osteoporotic patients Exclusion Criteria: none
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yukio Nakamura, MD, PhD
Phone
+81-263-37-2659
Email
yxn14@aol.jp
Facility Information:
Facility Name
Yukio Nakamura
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
3908621
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yukio Nakamura, MD, PhD
Phone
+81-263-37-2659
Email
yxn14@aol.jp
First Name & Middle Initial & Last Name & Degree
Yukio Nakamura, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
26666998
Citation
Nakamura Y, Kamimura M, Ikegami S, Mukaiyama K, Uchiyama S, Taguchi A, Kato H. Changes in serum vitamin D and PTH values using denosumab with or without bisphosphonate pre-treatment in osteoporotic patients: a short-term study. BMC Endocr Disord. 2015 Dec 15;15:81. doi: 10.1186/s12902-015-0077-3.
Results Reference
derived

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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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