Efficacy and Safety Study of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis

June 23, 2019 updated by: Hanlim Pharm. Co., Ltd.

For 12months, the Multi Center, Randomized, Open-label, Active Controlled Comparative Clinical Study to Assess the Efficacy and the Safety of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis

The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the efficacy and the safety of Risedronate with and without cholecalciferol on vitamin D status, Bone Mineral Density (BMD) and bone markers.

Study Type

Interventional

Enrollment (Actual)

1053

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male osteoporosis patients over 19 years of age

  2. Female osteoporosis patients with menopause

    • Definition of osteoporosis

      • They had a BMD T-score -2.5 or less at mean Lumbar spine(L1-L4), Femoral neck or total. Or evidence of at least one vertebral fracture

    • Definition of menopause(can be one of three condition)

      • For 12months spontaneous amenorrhea
      • For 6months spontaneous amenorrhea with serum FSH(Follicle stimulating hormone) is 40mlU/mL and over
      • 6weeks after bilateral ovariectomy whether hysterectomy or not.

Exclusion Criteria:

  1. Patients with esophagus disorder (i.e:esophagostenosis)
  2. Patients administered with osteoporosis therapy(except calcium, Vit.D medication)within the previous 3 Months
  3. Patients with serum calcium concentrations 8.0mg under
  4. Patients with severe nephropathy (CCr 30mL/min less)
  5. Patients with unable to sit upright or stand for 30minutes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Risendronate/Cholecalciferol combination
Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months
Drug: Risedronate/Cholecalciferol combination
Risendronate/Cholecalciferol combination once a week
Other Names:
  • RisenexPlus tablet
ACTIVE_COMPARATOR: Risedronate
Sedron tablet: one tablet once a week for 12months
Drug: Risedronate
Risedronate once a week
Other Names:
  • Sedron 35mg tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change of Bone Mineral Density (BMD) Value
Time Frame: baseline and 12 months
Higher Bone Mineral Density(BMD) value mean a better outcome.
baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change of 25OHD(25-hydroxyvitamin D)
Time Frame: baseline, 6months, 12months

range of 25OHD: 4.80~52.80 Higher 25OHD scores mean a better outcome.

If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.
baseline, 6months, 12months
PTH(Parathyroid Hormone Value)
Time Frame: baseline, 6months, 12months

range of PTH: 13~54 Higher PTH scores mean a worse outcome.

If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.
baseline, 6months, 12months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanlim Pharm. Co., Ltd.

Investigators

  • Principal Investigator: Hyoung-Moo Park, MD, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 4, 2011

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

April 15, 2014

Study Registration Dates

First Submitted

August 27, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (ESTIMATE)

August 29, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 5, 2019

Last Update Submitted That Met QC Criteria

June 23, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL_RSNP_401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoporosis

Clinical Trials on Risedronate/Cholecalciferol combination

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe