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Post-menopausal Women Osteoporosis(Phase III)

Primary Purpose

Postmenopausal Women Osteoporosis

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

risedronate combine

Risedronate

Placebo(for Risedronate)

Placebo(for risedronate combine)

About this trial

This is an interventional treatment trial for Postmenopausal Women Osteoporosis focused on measuring Osteoporosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

women osteoporosis
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
low levels of 25(OH)D > 9 ng/mL
patients who give written consent of agreement to voluntarily participate in the clinical study
patients who can read and understand written instructions

Exclusion Criteria:

patients who had contraindications to oral bisphosphonates, such as esophageal strictures
ALT, AST ≥ 2×UNL and Serum Creatinine ≥ 1.5×UNL
low levels of 25(OH)D (less than 9 ng/mL).
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.
drug administration after diagnosing as alcoholic or psychical disease
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

Sites / Locations

Chung-ang university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Risendronate and Cholecalciferol combination

Risedronate

Arm Description

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

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

Outcomes

Primary Outcome Measures

proportion of patients with 25(OH)D level < 20 ng/mL at 16 weeks.

Secondary Outcome Measures

proportion of patients with 25(OH)D level < 9 ng/mL at 16 weeks, change of 25(OH)D level and Bone Markers.

Secondary end point is : proportion of patients with 25(OH)D level < 9 ng/mL at 16 weeks change of 25(OH)D level change of BSAP change of CTX change of Ca change of phosphorous change of PTH change of 8-foot walking test, Sit-To-Stand test

Full Information

NCT ID

NCT01806792

First Posted

March 5, 2013

Last Updated

March 6, 2013

Sponsor

Hanlim Pharm. Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01806792

Brief Title

Post-menopausal Women Osteoporosis(Phase III)

Official Title

For 4 Months, the Multi Center, Double Blinded, Randomized, Active Controlled, Comparative Clinical Study to Assess the Efficacy and the Safety to Improvement Effect of Vit.D of Risenex Plus M Tablet in Patients With In Post-menopausal Women Osteoporosis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hanlim Pharm. Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postmenopausal Women Osteoporosis

Keywords

Osteoporosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Risendronate and Cholecalciferol combination

Arm Type

Experimental

Arm Description

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

Arm Title

Risedronate

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

risedronate combine

Other Intervention Name(s)

- Other name : Risenex M(risedronate 150mg and cholecalciferol 30,000 IU combined)

Intervention Type

Drug

Intervention Name(s)

Risedronate

Other Intervention Name(s)

Other name : Actonel(Risedronate 150mg)

Intervention Type

Drug

Intervention Name(s)

Placebo(for Risedronate)

Other Intervention Name(s)

once a month

Intervention Type

Drug

Intervention Name(s)

Placebo(for risedronate combine)

Other Intervention Name(s)

once a month

Primary Outcome Measure Information:

Title

proportion of patients with 25(OH)D level < 20 ng/mL at 16 weeks.

Time Frame

16 weeks form first drug adminstration.

Secondary Outcome Measure Information:

Title

proportion of patients with 25(OH)D level < 9 ng/mL at 16 weeks, change of 25(OH)D level and Bone Markers.

Description

Time Frame

16 weeks form first drug administration.

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: women osteoporosis 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 low levels of 25(OH)D > 9 ng/mL patients who give written consent of agreement to voluntarily participate in the clinical study patients who can read and understand written instructions Exclusion Criteria: patients who had contraindications to oral bisphosphonates, such as esophageal strictures ALT, AST ≥ 2×UNL and Serum Creatinine ≥ 1.5×UNL low levels of 25(OH)D (less than 9 ng/mL). 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. drug administration after diagnosing as alcoholic or psychical disease 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hyoung-Moo Park, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chung-ang university hospital

City

Seoul

ZIP/Postal Code

156-755

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Post-menopausal Women Osteoporosis(Phase III)

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