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

Phase 4

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Risedronate/Cholecalciferol combination; Drug: Risedronate

• Registration Number: NCT01675297
• Lead Sponsor: Hanlim Pharm. Co., Ltd.

Brief Summary

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

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 Timeline

• Study Start: 2011-07-04
• Study First Submitted: 2012-08-27
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-29
• Primary Completion: 2013-12
• Study Completion: 2014-04-15
• Results First Submitted: 2018-08-15
• Status Verified: 2019-03
• Results First Submitted QC: 2019-06-23
• Last Update Submitted: 2019-06-23
• Results First Posted: 2019-08-05
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1053

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risendronate/Cholecalciferol combination	Risedronate/Cholecalciferol combination	Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months
Risedronate	Risedronate	Sedron tablet: one tablet once a week for 12months

Primary Outcome Measures

Name	Time	Method
The Change of Bone Mineral Density (BMD) Value	baseline and 12 months	Higher Bone Mineral Density(BMD) value mean a better outcome.

Secondary Outcome Measures

Name	Time	Method
The Change of 25OHD(25-hydroxyvitamin D)	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.
PTH(Parathyroid Hormone Value)	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.

Trial Locations

Locations (1)

Chung-ang university hospital; 🇰🇷 Seoul, Korea, Republic of