Efficacy and Safety Study of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis

NCT01675297 | Completed Phase 4 Results

• 1 other identifier: HL_RSNP_401
• Study Type: interventional
• Target: 1,053
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis.

Conditions

Osteoporosis

Keywords

Risedronate, cholecalciferol, BMD

Outcome Measures

Primary Outcomes (1)

• The Change of Bone Mineral Density (BMD) Value

  Higher Bone Mineral Density(BMD) value mean a better outcome.

  baseline and 12 months

Secondary Outcomes (2)

• The Change of 25OHD(25-hydroxyvitamin D)

  baseline, 6months, 12months

• PTH(Parathyroid Hormone Value)

  baseline, 6months, 12months

Study Arms (2)

Risendronate/Cholecalciferol combination

EXPERIMENTAL

Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months

Drug: Risedronate/Cholecalciferol combination

Risedronate

ACTIVE COMPARATOR

Sedron tablet: one tablet once a week for 12months

Drug: Risedronate

Interventions

Risedronate/Cholecalciferol combination DRUG

Risendronate/Cholecalciferol combination once a week

Also known as: RisenexPlus tablet

Risendronate/Cholecalciferol combination

Risedronate DRUG

Risedronate once a week

Also known as: Sedron 35mg tablet

Risedronate

Eligibility Criteria

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

You may qualify if:

• Male osteoporosis patients over 19 years of age
• Female osteoporosis patients with menopause
• Definition of osteoporosis
• 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 40mlU/mL and over
• weeks after bilateral ovariectomy whether hysterectomy or not.

You may not qualify if:

• Patients with esophagus disorder (i.e:esophagostenosis)
• Patients administered with osteoporosis therapy(except calcium, Vit.D medication)within the previous 3 Months
• Patients with serum calcium concentrations 8.0mg under
• Patients with severe nephropathy (CCr 30mL/min less)
• Patients with unable to sit upright or stand for 30minutes

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

Chung-ang university hospital

Seoul, 156-755, South Korea

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Risedronic Acid; Tablets

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; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

Multiple centers proceded clinical study do not use the same measuring instrument.

Results Point of Contact

• Title: Clinical Trial Unit
• Organization: Hanlim Pharma

yrsong@hanlim.com

82-2-3489-6297

Study Officials

• Hyoung-Moo Park, MD

  Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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: August 27, 2012
• First Posted: August 29, 2012
• Study Start: July 4, 2011
• Primary Completion: December 1, 2013
• Study Completion: April 15, 2014
• Last Updated: August 5, 2019
• Results First Posted: August 5, 2019

Record last verified: 2019-03

Locations

KR (1)