Post-menopausal Women Osteoporosis(Phase III)

Phase 3

Completed

• Conditions: Postmenopausal Women Osteoporosis
• Interventions: Drug: risedronate combine; Drug: Risedronate; Drug: Placebo(for Risedronate); Drug: Placebo(for risedronate combine)

• Registration Number: NCT01806792
• Lead Sponsor: Hanlim Pharm. Co., Ltd.

Brief Summary

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

Detailed Description

The purpose of this study is to evaluate the efficacy and the safety of Monthly Risedronate with cholecalciferol on 25 Hydroxyvitamin D level and bone markers patients with osteoporosis.

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2010-08
• Study Completion: 2011-03
• Status Verified: 2013-03
• Study First Submitted: 2013-03-05
• Study First Submitted QC: 2013-03-06
• Last Update Submitted: 2013-03-06
• Study First Posted: 2013-03-07
• Last Update Posted: 2013-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

1. women osteoporosis
2. patients with a diagnosis of Postmenopausal over 6 Months if they had a bone mineral density T-score of < -2.5 at the mean lumbar spine (L1-4), femoral neck, or total, or a T-score of < -1.0 with radiologic evidence of at least one vertebral fracture. Menopause was defined as no natural menses for at least 1 year and a serum FSH level > 40 IU/L, with a reported hysterectomy
3. low levels of 25(OH)D > 9 ng/mL
4. patients who give written consent of agreement to voluntarily participate in the clinical study
5. patients who can read and understand written instructions

Exclusion Criteria

1. patients who had contraindications to oral bisphosphonates, such as esophageal strictures
2. ALT, AST ≥ 2×UNL and Serum Creatinine ≥ 1.5×UNL
3. low levels of 25(OH)D (less than 9 ng/mL).
4. Previous use of oral bisphosphonates and vitamin D were allowed, but a washout period was needed, depending on the duration of treatment. Two-year washout periods were needed for bisphosphonate users and 3-6-month periods were required for vitamin D users of > 200 IU.
5. drug administration after diagnosing as alcoholic or psychical disease
6. patients whom the investigators judge as improper to participate in this clinical trial 7)13.patients who have experience to participate in other clinical trial within 30 days prior to study participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risendronate and Cholecalciferol combination	risedronate combine	risedronate 150mg and cholecalciferol 30,000 IU 1 tablet + Placebo(for risedronate 150mg) 1 tablet by once a month.
Risendronate and Cholecalciferol combination	Placebo(for Risedronate)	risedronate 150mg and cholecalciferol 30,000 IU 1 tablet + Placebo(for risedronate 150mg) 1 tablet by once a month.
Risedronate	Risedronate	risedronate 150mg 1 tablet + Placebo(for risedronate 150mg and cholecalciferol 30,000 IU) 1 tablet by once a month.
Risedronate	Placebo(for risedronate combine)	risedronate 150mg 1 tablet + Placebo(for risedronate 150mg and cholecalciferol 30,000 IU) 1 tablet by once a month.

Primary Outcome Measures

Name	Time	Method
proportion of patients with 25(OH)D level < 20 ng/mL at 16 weeks.	16 weeks form first drug adminstration.

Secondary Outcome Measures

Name	Time	Method
proportion of patients with 25(OH)D level < 9 ng/mL at 16 weeks, change of 25(OH)D level and Bone Markers.	16 weeks form first drug administration.	Secondary end point is : 1. proportion of patients with 25(OH)D level \< 9 ng/mL at 16 weeks; 2. change of 25(OH)D level; 3. change of BSAP; 4. change of CTX; 5. change of Ca; 6. change of phosphorous; 7. change of PTH; 8. change of 8-foot walking test, Sit-To-Stand test

Trial Locations

Locations (1)

Chung-ang university hospital; 🇰🇷 Seoul, Korea, Republic of