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Status unknownNCT02156960Updated Oct 22, 2020

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

A Phase 4 interventional study of Denosumab treatment in osteoporotic patients and Teriparatide treatment in osteoporotic patients in Osteoporosis, sponsored by Shinshu University. Status unknown at 1 site in Japan. Open to participants aged 1 Year to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-22.

Sponsored by Shinshu University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
1 Year to 120 Years
Sex
All
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Study 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.

02

Conditions studied

  • Osteoporosis

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03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's planned enrollment of 100 is close to the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Shinshu University is the lead sponsor of 16 studies on the registry; 9 are open to participants now.

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

04

Who can participate

Ages eligible
1 Year to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Osteoporotic patients

Exclusion criteria

Exclusion Criteria:

  • none
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Denosumab and/or teriparatide treatment

    Denosumab and/or teriparatide treatment in osteoporotic patients

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

Interventions

  • DrugDenosumab treatment in osteoporotic patients

    To examine the effectiveness of denosumab in osteoporotic patients

  • DrugTeriparatide treatment in osteoporotic patients

    To examine the effectiveness of teriparatide in osteoporotic patients

  • DrugDenosumab and teriparatide treatment in osteoporotic patients

    To examine the effectiveness of denosumab and teriparatide in osteoporotic patients

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What researchers measure

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.

    Time frame: every 4-6 months

Secondary outcomes

  1. Changes of bone turnover markers

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

    Time frame: every 3-6 months

07

Study locations

1 of 1 sites recruiting
  • Yukio Nakamura
    Matsumoto, Nagano 3908621, Japan
    • Yukio Nakamura, MD, PhD · Contact · yxn14@aol.jp · +81-263-37-2659
    • Yukio Nakamura, MD, PhD · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 26666998 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02156960
Lead sponsor
Shinshu University
Responsible party
Yukio Nakamura (Assistant Professor, Shinshu University) — Principal investigator
First posted
Jun 5, 2014
Start date
May 2014
Primary completion
May 2015
Completion
Nov 2022 (estimated)
Last update
Oct 22, 2020

Study contacts

Yukio Nakamura, MD, PhD
Contact
yxn14@aol.jp
+81-263-37-2659
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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