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Status unknownNCT02491515Updated Nov 25, 2016

Effects of Denosumab Therapy for Japanese

An observational study in Osteoporosis, sponsored by Tomidahama Hospital. Status unknown at 1 site in Japan. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2016-11-25.

Sponsored by Tomidahama Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
500
Ages
45 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Osteoporosis

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Keywords

  • Osteoporosis
  • BMD
  • denosumab
  • previous therapy
03

In context

Osteoporosis

1,675 studies on the registry are indexed under Osteoporosis; 211 are open to participants now.

This study's planned enrollment of 500 is above the median of 180 across 461 observational studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Tomidahama Hospital is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Osteoporotic patients who admit to our hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Osteoporotic patients

Exclusion criteria

Exclusion Criteria:

  • cancer, hypercalcemia, etc (i.e. patients who could not use denosumab)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Interventions

  • every 6 month injection

    Also known as: Prolia

06

What researchers measure

Primary outcomes

  1. BMD increase by denosumab in Japanese

    The investigators evaluate BMD increase by denosmab in Japanese patients.

    Time frame: Up to 48 months

Secondary outcomes

  1. The determinants related to BMD increase and fracture prevention for denosumab treatment

    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.

    Time frame: Up to 48 months

  2. Effects of previous therapy to denosumab

    The investigators evaluate effects of previous osteoporosis treatment to denosumab in BMD increase and bone turnover marker response using univariate and multivariate analysis.

    Time frame: Up to 48 months

07

Study locations

1 of 1 sites recruiting
  • Tomidahama Hospital
    Yokkaichi, Mie-ken 510-8008, Japan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02491515
Lead sponsor
Tomidahama Hospital
Responsible party
Toshihiko Kono (Head of Hospital, Tomidahama Hospital) — Principal investigator
First posted
Jul 8, 2015
Start date
Jul 2012
Primary completion
Jun 2017 (estimated)
Completion
Dec 2020 (estimated)
Last update
Nov 25, 2016

Study contacts

Rui Niimi, MD
Contact
furikakefuri@hotmail.co.jp
+81593650023
Rui Niimi, MD
study director · Tomidahama Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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