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RecruitingNCT03183557Updated Sep 21, 2021

Efficacy of Zoledronic Acid in Osteoporosis

A Phase 2 interventional study of "Zoledronic acid", "Reclast®" and "Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®" in Osteoporosis, sponsored by Shinshu University. Recruiting at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-09-21.

Sponsored by Shinshu University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2022, 3 years 10 months ago, but the record still lists the study as recruiting.
  • Started Oct 2017; still recruiting 8 years 11 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

There has been no comparative data between Zoledronic acid and Zoledronic acid combined with active vitamin D in primary and secondary osteoporosis.

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
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Osteoporotic patients who want to take zoledronic acid

Exclusion criteria

Exclusion Criteria:

  • Patients who are allergic to zoledronic acid or vitamin D
  • Patients who are pregnant or breast-feeding
  • Patients who have not taken zoledronic acid for the last 2 years
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    ZA alone

    Drug: "Zoledronic acid", "Reclast®"

  • Active comparator
    ZA plus VD

    Drug: "Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®"

Interventions

  • Drug"Zoledronic acid", "Reclast®"

    To examine the efficacy of zoledronic acid in osteoporosis

  • Drug"Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®"

    To examine the efficacy of zoledronic acid plus alfacalcidol in osteoporosis

06

What researchers measure

Primary outcomes

  1. Bone mineral density

    Time frame: Change from Baseline Values at 1 year

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

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03183557
Lead sponsor
Shinshu University
Responsible party
Yukio Nakamura (Associate professor at Shinshu University, Shinshu University) — Principal investigator
First posted
Jun 12, 2017
Start date
Oct 12, 2017
Primary completion
Dec 8, 2022 (estimated)
Completion
Jun 8, 2025 (estimated)
Last update
Sep 21, 2021

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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