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)

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)

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: Risedronate/Cholecalciferol combination(montly); Drug: Risedronate/Cholecalciferol combination(weekly)

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)

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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
5. Patients who participated in clinical trial(HL_RSNP_401) must have taken the Risenexplus and finish the study for 12 months.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Risenex M; Patients who were treated with Resenex M (Risendronate/Cholecalciferol combination in one tablet) once a month for 12months	Drug: Risedronate/Cholecalciferol combination(montly); once a month; Other Names: Risenex M
Active Comparator: Risenex Plus; Patients who were treated with Risenex plus (Risendronate/Cholecalciferol combination in one tablet) once a week for 12months	Drug: Risedronate/Cholecalciferol combination(montly); once a month; Other Names: Risenex M; Drug: Risedronate/Cholecalciferol combination(weekly); once a week; Other Names: Risenex Plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The propotion of patients with 25(Oh)D level <20mg/ml of 12 months	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of Bone Mineral Density(BMD) value	The change of Bone Mineral Density(BMD) value[Time frame: 1 year] The change of PTH(Parathyroid hormone value) [Time frame:6months,1 year] The change of Compliance - overall groups of Risenex plus vs Risenex M(2groups)	1year
The change of PTH(Parathyroid hormone value)	The change of Bone Mineral Density(BMD) value[Time frame: 1 year] The change of PTH(Parathyroid hormone value) [Time frame:6months,1 year] The change of Compliance - overall groups of Risenex plus vs Risenex M(2groups)	6months,1 year
The change of Compliance - overall groups of Risenex plus vs Risenex M	The change of Bone Mineral Density(BMD) value[Time frame: 1 year] The change of PTH(Parathyroid hormone value) [Time frame:6months,1 year] The change of Compliance - overall groups of Risenex plus vs Risenex M(2groups	1year
The change of 25(Oh)D level in patients.		6months,1year

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.
• Investigators: Principal Investigator: Youngki Min, MD, Samsung Medical Center Seoul

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): May 29, 2014
• Study Completion (Actual): March 31, 2016

Study Registration Dates

• First Submitted: July 16, 2013
• First Submitted That Met QC Criteria: July 17, 2013
• First Posted (Estimate): July 22, 2013

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Risedronate,cholecalciferol,BMD,montly,weekly,compliance
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Micronutrients; Membrane Transport Modulators; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Vitamin D; Cholecalciferol; Risedronic Acid; Etidronic Acid
• Other Study ID Numbers: HL_RSNM_401