NCT02156960

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
7.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

May 31, 2014

Last Update Submit

October 19, 2020

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Changes of bone mineral density

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

    every 4-6 months

Secondary Outcomes (1)

  • Changes of bone turnover markers

    every 3-6 months

Study Arms (1)

Denosumab and/or teriparatide treatment

EXPERIMENTAL

Denosumab and/or teriparatide treatment in osteoporotic patients

Drug: Denosumab treatment in osteoporotic patientsDrug: Teriparatide treatment in osteoporotic patientsDrug: Denosumab and teriparatide treatment in osteoporotic patients

Interventions

Denosumab treatment in osteoporotic patientsDRUG

To examine the effectiveness of denosumab in osteoporotic patients

Denosumab and/or teriparatide treatment
Teriparatide treatment in osteoporotic patientsDRUG

To examine the effectiveness of teriparatide in osteoporotic patients

Denosumab and/or teriparatide treatment
Denosumab and teriparatide treatment in osteoporotic patientsDRUG

To examine the effectiveness of denosumab and teriparatide in osteoporotic patients

Denosumab and/or teriparatide treatment

Eligibility Criteria

Age1 Year - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Osteoporotic patients

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yukio Nakamura

Matsumoto, Nagano, 3908621, Japan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26666998DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Yukio Nakamura, MD, PhD

CONTACT

+81-263-37-2659yxn14@aol.jp

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 31, 2014

First Posted

June 5, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2015

Study Completion

November 1, 2022

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations

JP(1)