Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
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.
ClinicalTrials.gov Identifier: NCT03183557
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : September 6, 2018
Sponsor:
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

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03183557


Contacts
Layout table for location contacts
Contact: Yukio Nakamura, MD, PhD +81-263-37-2659 yxn14@aol.jp

Locations
Layout table for location information
Japan
Yukio Nakamura Recruiting
Matsumoto, Nagano, Japan, 3908621
Contact: Yukio Nakamura, MD, PhD    +81-263-37-2659    yxn14@aol.jp   
Principal Investigator: Yukio Nakamura, MD, PhD         
Sponsors and Collaborators
Shinshu University

Layout table for additonal information
Responsible Party: Yukio Nakamura, Associate professor at Shinshu University, Shinshu University
ClinicalTrials.gov 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

Layout table for additional information
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:
Layout table for MeSH terms
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Hydroxycholecalciferols
Zoledronic Acid
Alfacalcidol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents