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

Hanlim Pharm

Status and phase: Completed; Phase 4

Conditions: Osteoporosis

Treatments: Drug: Risedronate/Cholecalciferol combination; Drug: Risedronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01675297

HL_RSNP_401

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,053 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,053 participants in 2 patient groups

Risendronate/Cholecalciferol combination

Experimental group

Description:

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

Treatment:

Drug: Risedronate/Cholecalciferol combination

Risedronate

Active Comparator group

Description:

Sedron tablet: one tablet once a week for 12months

Treatment:

Drug: Risedronate