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

Osteoporosis Clinical Trial

Official title:

For 12months, the Multi Center, Randomized, Open-label Comparative Clinical Study to Evaluate the Efficacy and the Safety of Monthly(RisenexM Group) Versus Weekly Oral Risedronate(Risenexsplus Group) With Vitamin D in Compliance, Improvement of Vitamin D and BMD in Korean Postmenopausal Osteoporotic Women(Phase IV)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904110
• Other study ID #: HL_RSNM_401
• Status: Completed
• Phase: Phase 4
• Start date: December 2012
• Est. completion date: March 31, 2016

Study information

• Verified date: August 2018
• Source: Hanlim Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: March 31, 2016
• Est. primary completion date: May 29, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Risedronate/Cholecalciferol combination(montly)
once a month
• Risedronate/Cholecalciferol combination(weekly)
once a week

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The propotion of patients with 25(Oh)D level <20mg/ml of 12 months		1 year
Secondary	The change of Bone Mineral Density(BMD) value	The change of Bone Mineral Density(BMD) value[Time frame: 1 year] The change of PTH(Parathyroid hormone value) [Time frame:6months,1 year] The change of Compliance - overall groups of Risenex plus vs Risenex M(2groups)	1year
Secondary	The change of PTH(Parathyroid hormone value)	The change of Bone Mineral Density(BMD) value[Time frame: 1 year] The change of PTH(Parathyroid hormone value) [Time frame:6months,1 year] The change of Compliance - overall groups of Risenex plus vs Risenex M(2groups)	6months,1 year
Secondary	The change of Compliance - overall groups of Risenex plus vs Risenex M	The change of Bone Mineral Density(BMD) value[Time frame: 1 year] The change of PTH(Parathyroid hormone value) [Time frame:6months,1 year] The change of Compliance - overall groups of Risenex plus vs Risenex M(2groups	1year
Secondary	The change of 25(Oh)D level in patients.		6months,1year