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Trial record 7 of 165 for:    Recruiting, Not yet recruiting, Available Studies | Osteoporosis

Efficacy of Zoledronic Acid in Osteoporosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03183557
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : September 6, 2018
Information provided by (Responsible Party):
Yukio Nakamura, Shinshu University

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

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: "Zoledronic acid", "Reclast®" Drug: "Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®" Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Examination of Bone Metabolism and Bone Mineral Density by Zoledronic Acid in Primary and Secondary Osteoporosis
Actual Study Start Date : October 12, 2017
Estimated Primary Completion Date : December 8, 2018
Estimated Study Completion Date : June 8, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: ZA alone Drug: "Zoledronic acid", "Reclast®"
To examine the efficacy of zoledronic acid in osteoporosis

Active Comparator: ZA plus VD Drug: "Zoledronic acid", "Reclast®" and "active vitamin D", "alfacalcidol®"
To examine the efficacy of zoledronic acid plus alfacalcidol in osteoporosis

Primary Outcome Measures :
  1. Bone mineral density [ Time Frame: Change from Baseline Values at 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male patients are separately analyzed
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Osteoporotic patients who want to take zoledronic acid

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03183557

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Contact: Yukio Nakamura, MD, PhD +81-263-37-2659

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Yukio Nakamura Recruiting
Matsumoto, Nagano, Japan, 3908621
Contact: Yukio Nakamura, MD, PhD    +81-263-37-2659   
Principal Investigator: Yukio Nakamura, MD, PhD         
Sponsors and Collaborators
Shinshu University

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Responsible Party: Yukio Nakamura, Associate professor at Shinshu University, Shinshu University Identifier: NCT03183557     History of Changes
Other Study ID Numbers: Zol2017
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Zoledronic Acid
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents