Post-menopausal Women Osteoporosis(Phase III)

March 6, 2013 updated by: Hanlim Pharm. Co., Ltd.

For 4 Months, the Multi Center, Double Blinded, Randomized, Active Controlled, Comparative Clinical Study to Assess the Efficacy and the Safety to Improvement Effect of Vit.D of Risenex Plus M Tablet in Patients With In Post-menopausal Women 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 Monthly Risedronate with cholecalciferol on 25 Hydroxyvitamin D level and bone markers patients with osteoporosis.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. women osteoporosis
  2. patients with a diagnosis of Postmenopausal over 6 Months if they had a bone mineral density T-score of < -2.5 at the mean lumbar spine (L1-4), femoral neck, or total, or a T-score of < -1.0 with radiologic evidence of at least one vertebral fracture. Menopause was defined as no natural menses for at least 1 year and a serum FSH level > 40 IU/L, with a reported hysterectomy
  3. low levels of 25(OH)D > 9 ng/mL
  4. patients who give written consent of agreement to voluntarily participate in the clinical study
  5. patients who can read and understand written instructions

Exclusion Criteria:

  1. patients who had contraindications to oral bisphosphonates, such as esophageal strictures
  2. ALT, AST ≥ 2×UNL and Serum Creatinine ≥ 1.5×UNL
  3. low levels of 25(OH)D (less than 9 ng/mL).
  4. Previous use of oral bisphosphonates and vitamin D were allowed, but a washout period was needed, depending on the duration of treatment. Two-year washout periods were needed for bisphosphonate users and 3-6-month periods were required for vitamin D users of > 200 IU.
  5. drug administration after diagnosing as alcoholic or psychical disease
  6. patients whom the investigators judge as improper to participate in this clinical trial 7)13.patients who have experience to participate in other clinical trial within 30 days prior to study participation

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: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Risendronate and Cholecalciferol combination
risedronate 150mg and cholecalciferol 30,000 IU 1 tablet + Placebo(for risedronate 150mg) 1 tablet by once a month.
Drug: risedronate combine
Other Names:
  • - Other name : Risenex M(risedronate 150mg and cholecalciferol 30,000 IU combined)
Drug: Placebo(for Risedronate)
Other Names:
  • once a month
ACTIVE_COMPARATOR: Risedronate
risedronate 150mg 1 tablet + Placebo(for risedronate 150mg and cholecalciferol 30,000 IU) 1 tablet by once a month.
Drug: Risedronate
Other Names:
  • Other name : Actonel(Risedronate 150mg)
Drug: Placebo(for risedronate combine)
Other Names:
  • once a month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
proportion of patients with 25(OH)D level < 20 ng/mL at 16 weeks.
Time Frame: 16 weeks form first drug adminstration.
16 weeks form first drug adminstration.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of patients with 25(OH)D level < 9 ng/mL at 16 weeks, change of 25(OH)D level and Bone Markers.
Time Frame: 16 weeks form first drug administration.

Secondary end point is :

  1. proportion of patients with 25(OH)D level < 9 ng/mL at 16 weeks
  2. change of 25(OH)D level
  3. change of BSAP
  4. change of CTX
  5. change of Ca
  6. change of phosphorous
  7. change of PTH
  8. change of 8-foot walking test, Sit-To-Stand test
16 weeks form first drug administration.

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

November 1, 2009

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

March 5, 2013

First Submitted That Met QC Criteria

March 6, 2013

First Posted (ESTIMATE)

March 7, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 7, 2013

Last Update Submitted That Met QC Criteria

March 6, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL_RSNPM_301

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.

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