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To Evaluate the Efficacy and the Safety of Monthly Versus Weekly Oral Risedronate With Vitamin D in Compliance, Improvement of Vitamin D and BMD in Korean Postmenopausal Osteoporotic Women | Clinical Trials | Clareo Health

COMPLETEDPHASE4

To Evaluate the Efficacy and the Safety of Monthly Versus Weekly Oral Risedronate With Vitamin D in Compliance, Improvement of Vitamin D and BMD in Korean Postmenopausal Osteoporotic Women

For 12months, the Multi Center, Randomized, Open-label Comparative Clinical Study to Evaluate the Efficacy and the Safety of Monthly(RisenexM Group) Versus Weekly Oral Risedronate(Risenexsplus Group) With Vitamin D in Compliance, Improvement of Vitamin D and BMD in Korean Postmenopausal Osteoporotic Women(Phase IV)

NCT01904110•Hanlim Pharm. Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the Efficacy and the Safety of Monthly(RisenexM group) versus Weekly Oral risedronate(Risenexsplus group) in Korean postmenopausal osteoporotic women(Phase IV)

Detailed Description

The purpose of this study is to evaluate the Efficacy and the Safety of Monthly(RisenexM group) versus Weekly Oral risedronate(Risenexsplus group) with Vitamin D in compliance, improvement of vitaminD and BMD in Korean postmenopausal osteoporotic women(Phase IV)

Eligibility

Age

19 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Female osteoporosis patients over 19years of age(with menopause).
•Definition of osteporosis
•* 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 40 mlIU/mL and over
•* 6weeks after bilateral ovariectomy whether hysterectomy of not
•2. Patients who can be treated with oral bisphosphonate drugs
•3. Patients who have adequate to be measured DXA(Dual energy x-ray absorptiometry)
•4. Patients who made a voluntary agreement after explanation of this study
+1 more criteria

Exclusion Criteria

•1. Patients with esophagus disorder.
•2. Patients administered with osteoprosis therapy(except calcium,Vit.D medication) within previous 3 months
•3. Patients with serum calcium concentrations 8.0mg/dL under.
•4. Patients with severe nephropathy(serum creatinine\> doulble of normal level
•5. Patients with unable to sit upright or stand 30minutes.

Locations (1)

Samsung Medical Center

Seoul, South Korea

Key Dates

Start Date

December 1, 2012

Primary Completion Date

May 29, 2014

Completion Date

March 31, 2016

Last Updated

August 29, 2018

Enrollment

196

ACTUAL participants

Conditions

Osteoporosis

Interventions

Risedronate/Cholecalciferol combination(montly)

DRUG

Risedronate/Cholecalciferol combination(weekly)

DRUG

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

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OsteoporosisLower Limb Fracture

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RECRUITINGPHASE4

Step-down Therapy After Long-term Osteoporosis Treatment

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Osteoporosis

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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To Evaluate the Efficacy and the Safety of Monthly Versus Weekly Oral Risedronate With Vitamin D in Compliance, Improvement of Vitamin D and BMD in Korean Postmenopausal Osteoporotic Women

Inclusion Criteria

Exclusion Criteria

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

Step-down Therapy After Long-term Osteoporosis Treatment

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