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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Hanlim Pharm. Co., Ltd..
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd. Identifier:
First received: August 27, 2012
Last updated: January 17, 2013
Last verified: January 2013
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
Drug: Risedronate/Cholecalciferol combination
Drug: Risedronate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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 ]

Secondary Outcome Measures:
  • The change of 25OHD(25-hydroxyvitamin D)/PTH(Parathyroid hormone value) [ Time Frame: 6months, one year ]

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.

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01675297

Contact: Na Hyun Kang 82-2-3489-6298
Contact: Young Ran Song 82-2-3489-6297

Korea, Republic of
Chung-ang university hospital Recruiting
Seoul, Korea, Republic of, 156-755
Contact: Ah Rong Choi, CRC    8210-2036-4353   
Contact: Nahyun Kang, CRA    822-3489-6298   
Principal Investigator: Hyoung-Moo Park, MD         
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.
Principal Investigator: Hyoung-Moo Park, MD Chung-Ang University Hosptial, Chung-Ang University College of Medicine
  More Information

Responsible Party: Hanlim Pharm. Co., Ltd. Identifier: NCT01675297     History of Changes
Other Study ID Numbers: HL_RSNP_401
Study First Received: August 27, 2012
Last Updated: January 17, 2013

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

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronate Sodium
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs
Growth Substances processed this record on May 22, 2017