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

Hanlim Pharm

Status and phase: Completed; Phase 4

Conditions: Osteoporosis

Treatments: Drug: Risedronate/Cholecalciferol combination(montly); Drug: Risedronate/Cholecalciferol combination(weekly)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01904110

HL_RSNM_401

Details and patient eligibility

About

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)

Full description

The purpose of this study is to evaluate the Efficacy and the Safety of Monthly(RisenexM group) versus Weekly Oral risedronate(Risenexsplus group) with Vitamin D in compliance, improvement of vitaminD and BMD in Korean postmenopausal osteoporotic women(Phase IV)

Enrollment: 196 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

Risenex M

Experimental group

Description:

Patients who were treated with Resenex M (Risendronate/Cholecalciferol combination in one tablet) once a month for 12months

Treatment:

Drug: Risedronate/Cholecalciferol combination(montly)

Risenex Plus

Active Comparator group

Description:

Patients who were treated with Risenex plus (Risendronate/Cholecalciferol combination in one tablet) once a week for 12months

Treatment:

Drug: Risedronate/Cholecalciferol combination(weekly)

Drug: Risedronate/Cholecalciferol combination(montly)