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

• Status: Completed
• Trial end date: 2016-03-31
• Target enrollment: 0
• Participant gender: Female

Summary

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)

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

Details

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

Criteria

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.