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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675297
• Other study ID #: HL_RSNP_401
• Status: Completed
• Phase: Phase 4
• Start date: July 4, 2011
• Est. completion date: April 15, 2014

Study information

• Verified date: March 2019
• Source: Hanlim Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1053
• Est. completion date: April 15, 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Risedronate/Cholecalciferol combination
Risendronate/Cholecalciferol combination once a week
• Risedronate
Risedronate once a week

Locations

Country	Name	City	State
Korea, Republic of	Chung-ang university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change of Bone Mineral Density (BMD) Value	Higher Bone Mineral Density(BMD) value mean a better outcome.	baseline and 12 months
Secondary	The Change of 25OHD(25-hydroxyvitamin D)	range of 25OHD: 4.80~52.80 Higher 25OHD scores mean a better outcome.; If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.	baseline, 6months, 12months
Secondary	PTH(Parathyroid Hormone Value)	range of PTH: 13~54 Higher PTH scores mean a worse outcome.; If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.	baseline, 6months, 12months