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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Hanlim Pharm. Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01675297
First received: August 27, 2012
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Osteoporosis
Drug: Risedronate/Cholecalciferol combination
Drug: Risedronate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: For 12months, the Multi Center, Randomized, Open-label, Active Controlled Comparative Clinical Study to Assess the Efficacy and the Safety of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis

Resource links provided by NLM:


Further study details as provided by Hanlim Pharm. Co., Ltd.:

Primary Outcome Measures:
  • The change of Bone Mineral Density (BMD) value [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change of 25OHD(25-hydroxyvitamin D)/PTH(Parathyroid hormone value) [ Time Frame: 6months, one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1170
Study Start Date: July 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Risendronate/Cholecalciferol combination
Experimental: Administer Risendronate/Cholecalciferol combination one tablet once a week for 12months.
Drug: Risedronate/Cholecalciferol combination
once a week
Other Name: RisenexPlus tablet
Active Comparator: Risedronate
Active comparator: Administer Risendronate one tablet once a week for 12months.
Drug: Risedronate
once a week
Other Name: Sedron 35mg tablet

Detailed Description:

The purpose of this study is to evaluate the efficacy and the safety of Risedronate with and without cholecalciferol on vitamin D status, Bone Mineral Density (BMD) and bone markers.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male osteoporosis patients over 19 years of age
  2. 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
      • 6weeks after bilateral ovariectomy whether hysterectomy or not.

Exclusion Criteria:

  1. Patients with esophagus disorder (i.e:esophagostenosis)
  2. Patients administered with osteoporosis therapy(except calcium, Vit.D medication)within the previous 3 Months
  3. Patients with serum calcium concentrations 8.0mg under
  4. Patients with severe nephropathy (CCr 30mL/min less)
  5. Patients with unable to sit upright or stand for 30minutes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01675297

Contacts
Contact: Na Hyun Kang 82-2-3489-6298 nahyun.kang@hanlim.com
Contact: Young Ran Song 82-2-3489-6297 yrsong@hanlim.com

Locations
Korea, Republic of
Chung-ang university hospital Recruiting
Seoul, Korea, Republic of, 156-755
Contact: Ah Rong Choi, CRC    8210-2036-4353    baby123@naver.com   
Contact: Nahyun Kang, CRA    822-3489-6298    nahyun.kang@hanlim.com   
Principal Investigator: Hyoung-Moo Park, MD         
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.
Investigators
Principal Investigator: Hyoung-Moo Park, MD Chung-Ang University Hospital
  More Information

No publications provided

Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT01675297     History of Changes
Other Study ID Numbers: HL_RSNP_401
Study First Received: August 27, 2012
Last Updated: January 17, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanlim Pharm. Co., Ltd.:
Risedronate, cholecalciferol, BMD

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Cholecalciferol
Risedronic acid
Etidronic Acid
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014