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

• Status: Completed
• Trial end date: 2014-04-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanlim Pharm. Co., Ltd.
• Treatments: Cholecalciferol; Etidronic Acid; Risedronate Sodium; Risedronic Acid

Criteria

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