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 | Completed Phase 4

• 1 other identifier: HL_RSNM_401
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Osteoporosis

Keywords

Risedronate,cholecalciferol,BMD,montly,weekly,compliance

Outcome Measures

Primary Outcomes (1)

• The propotion of patients with 25(Oh)D level <20mg/ml of 12 months

  1 year

Secondary Outcomes (4)

• The change of Bone Mineral Density(BMD) value

  1year

• The change of PTH(Parathyroid hormone value)

  6months,1 year

• The change of Compliance - overall groups of Risenex plus vs Risenex M

  1year

• The change of 25(Oh)D level in patients.

  6months,1year

Study Arms (2)

Risenex M

EXPERIMENTAL

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

Drug: Risedronate/Cholecalciferol combination(montly)

Risenex Plus

ACTIVE COMPARATOR

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

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

Interventions

Risedronate/Cholecalciferol combination(montly) DRUG

once a month

Also known as: Risenex M

Risenex M; Risenex Plus

Risedronate/Cholecalciferol combination(weekly) DRUG

once a week

Also known as: Risenex Plus

Risenex Plus

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• weeks after bilateral ovariectomy whether hysterectomy of not
• Patients who can be treated with oral bisphosphonate drugs
• Patients who have adequate to be measured DXA(Dual energy x-ray absorptiometry)
• Patients who made a voluntary agreement after explanation of this study
• Patients who participated in clinical trial(HL\_RSNP\_401) must have taken the Risenexplus and finish the study for 12 months.

You may not qualify if:

• Patients with esophagus disorder.
• Patients administered with osteoprosis therapy(except calcium,Vit.D medication) within previous 3 months
• Patients with serum calcium concentrations 8.0mg/dL under.
• Patients with severe nephropathy(serum creatinine\> doulble of normal level
• Patients with unable to sit upright or stand 30minutes.

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Youngki Min, MD

  Samsung Medical Center Seoul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: July 22, 2013
• Study Start: December 1, 2012
• Primary Completion: May 29, 2014
• Study Completion: March 31, 2016
• Last Updated: August 29, 2018

Record last verified: 2018-08

Locations

KR (1)