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

NCT01904110 — Phase 4, Completed, 196 participants, Hanlim Pharm. Co., Ltd.

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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)

Registry	NCT01904110
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	196 (Actual)
Sponsor	Hanlim Pharm. Co., Ltd. (Industry)
Conditions	Osteoporosis
Interventions	Risedronate/Cholecalciferol combination(montly), Risedronate/Cholecalciferol combination(weekly) (Drug)
Dates	start 2012-12-01, primary completion 2014-05-29, completion 2016-03-31, first posted 2013-07-22, last updated 2018-08-29
Locations	1 site in South Korea

-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)

Expand all sections · Collapse all

+Detailed 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)

+Arms and interventions

Arm	Type	Interventions	Description
Risenex M	Experimental	Drug: Risedronate/Cholecalciferol combination(montly)	Patients who were treated with Resenex M (Risendronate/Cholecalciferol combination in one tablet) once a month for 12months
Risenex Plus	Active comparator	Drug: Risedronate/Cholecalciferol combination(montly); Drug: Risedronate/Cholecalciferol combination(weekly)	Patients who were treated with Risenex plus (Risendronate/Cholecalciferol combination in one tablet) once a week for 12months

Risedronate/Cholecalciferol combination(montly) (Drug), also known as Risenex M: once a month
Risedronate/Cholecalciferol combination(weekly) (Drug), also known as Risenex Plus: once a week

+Outcome measures

Primary outcomes

The propotion of patients with 25(Oh)D level <20mg/ml of 12 months [1 year]

Secondary outcomes

The change of Bone Mineral Density(BMD) value [1year]: 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)
The change of PTH(Parathyroid hormone value) [6months,1 year]: 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)
The change of Compliance - overall groups of Risenex plus vs Risenex M [1year]: 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
The change of 25(Oh)D level in patients. [6months,1year]

+Eligibility

Sex: Female, ages: 19 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Samsung Medical Center	Seoul	South Korea

+Investigators

Youngki Min, MD, Principal investigator, Samsung Medical Center Seoul