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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1053 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-04

Study Completion Date

2014-04-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Risendronate/Cholecalciferol combination

Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months

Group Type EXPERIMENTAL

Risedronate/Cholecalciferol combination

Intervention Type DRUG

Risendronate/Cholecalciferol combination once a week

Risedronate

Sedron tablet: one tablet once a week for 12months

Group Type ACTIVE_COMPARATOR

Risedronate

Intervention Type DRUG

Risedronate once a week

Interventions

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Risedronate/Cholecalciferol combination

Risendronate/Cholecalciferol combination once a week

Intervention Type DRUG

Risedronate

Risedronate once a week

Intervention Type DRUG

Other Intervention Names

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RisenexPlus tablet Sedron 35mg tablet

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No