Post-menopausal Women Osteoporosis(Phase III)

NCT ID: NCT01806792

Last Updated: 2013-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-03-31

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.

Conditions

Postmenopausal Women Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Risendronate and Cholecalciferol combination

risedronate 150mg and cholecalciferol 30,000 IU 1 tablet + Placebo(for risedronate 150mg) 1 tablet by once a month.

Group Type: EXPERIMENTAL

risedronate combine

Intervention Type: DRUG

Placebo(for Risedronate)

Intervention Type: DRUG

Risedronate

risedronate 150mg 1 tablet + Placebo(for risedronate 150mg and cholecalciferol 30,000 IU) 1 tablet by once a month.

Group Type: ACTIVE_COMPARATOR

Risedronate

Intervention Type: DRUG

Placebo(for risedronate combine)

Intervention Type: DRUG

Interventions

risedronate combine

Intervention Type: DRUG

Risedronate

Intervention Type: DRUG

Placebo(for Risedronate)

Intervention Type: DRUG

Placebo(for risedronate combine)

Intervention Type: DRUG

Other Intervention Names

- Other name : Risenex M(risedronate 150mg and cholecalciferol 30,000 IU combined); Other name : Actonel(Risedronate 150mg); once a month; once a month

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hanlim Pharm. Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyoung-Moo Park, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Chung-ang university hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

HL_RSNPM_301

Identifier Type: -

Identifier Source: org_study_id