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The Efficacy and Safety of BHH10 in Patients with Osteoporosis : a Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Trial

Status Approved

First Submitted Date

2016/03/09
Registered Date

2016/03/14
Last Updated Date

2017/02/08

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0001842
Unique Protocol ID	KCRO_2014_BHH10
Public/Brief Title	The Efficacy and Safety of BHH10 in Patients with Osteoporosis
Scientific Title	The Efficacy and Safety of BHH10 in Patients with Osteoporosis : a Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Trial
Acronym
MFDS Regulated Study	Yes
IND/IDE Protocol	Yes
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KOMCIRB-151218-HR-049
Approval Date	2016-02-05
Institutional Review Board Name	Kyung Hee University Korean Medicine Hospital Institutional Review Board
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Jae-dong Lee
Title	Ph.D.
Telephone	+82-2-958-9202
Affiliation	Kyung Hee University Oriental Medical Center
Address	23, Kyungheedae-ro, Dongdaemun-gu, Seoul
Contact Person for Public Queries
Name	Seunghoon Lee
Title	Ph.D.
Telephone	+82-2-958-9202
Affiliation	Kyung Hee University Oriental Medical Center
Address	23, Kyungheedae-ro, Dongdaemun-gu, Seoul
Contact Person for Updating Information
Name	Yeeun Cho
Title	M.D.
Telephone	+82-2-958-2958
Affiliation	Kyung Hee University Oriental Medical Center
Address	23, Kyungheedae-ro, Dongdaemun-gu, Seoul

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 2
Overall Recruitment Status	Recruiting
Date of First Enrollment	2016-03-24 Actual
Target Number of Participant	168
Primary Completion Date	2017-12-31 , Anticipated
Study Completion Date	2017-12-31 , Anticipated
Name of Study	Kyung Hee University Oriental Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2016-03-24 ,
Recruitment Status by Participating Study Site 2
Name of Study	Kyung Hee University Oriental Medicine Hospital at Gangdong
Recruitment Status	Recruiting
Date of First Enrollment	2016-03-29 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Ministry of Health & Welfare
Organization Type	Government
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Hanpoong Pharm & Foods
Organization Type	Pharmaceutical Company

7. Study Summary

Study Summary Information
Lay Summary	This trial is a double-blind, randomized, multicenter, placebo-controlled, phase IIb clinical trial for patients with osteoporosis. Patients who signed informed consent voluntarily and eligible for this study will be assinged randomly to one of two groups (BHH10 group and placebo group). Patients will take two tablets of BHH10 or placebo three times per day during 12 weeks. Bone mineral density will be checked as primary efficacy outcome. As second efficacy outcomes, osteoporosis markers, questionnaire about the deficiency syndrome of kidney index, questionnaire about health-related quality of life status (EQ-5D index) will be checked. And to evalutae safety of BHH10, researchers will check adverse event, laboratory experiment, vital sign and ECG.

Study Summary Information

Lay Summary

This trial is a double-blind, randomized, multicenter, placebo-controlled, phase IIb clinical trial  for patients with osteoporosis.
Patients who signed informed consent voluntarily and eligible for this study will be assinged randomly to one of two groups (BHH10 group and placebo group). Patients will take two tablets of BHH10 or placebo three times per day during 12 weeks. 
Bone mineral density will be checked as primary efficacy outcome. As second efficacy outcomes, osteoporosis markers, questionnaire about the deficiency syndrome of kidney index, questionnaire about health-related quality of life status (EQ-5D index) will be checked. And to evalutae safety of BHH10, researchers will check adverse event, laboratory experiment, vital sign and ECG.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Phase2
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator, Caregiver, Outcome Accessor
Allocation	RCT
Intervention Type	Drug
Intervention Description	Patients assigned to Experimental group (BHH10 group) take two tablets of BHH10 (BHH10 800mg/tab) three times per day for 12 weeks. Patients assigned to Control group (placebo group) take two tablets of placebo three times per day for 12 weeks.
Number of Arms	2
Arm 1	Arm Label BHH10 group
	Target Number of Participant 84
	Arm Type Experimental
	Arm Description Patients assigned to Experimental group (BHH10 group) take two tablets of BHH10 (BHH10 800mg/tab) three times per day for 12 weeks.
Arm 2	Arm Label Placebo group
	Target Number of Participant 84
	Arm Type Placebo comparator
	Arm Description Patients assigned to Control group (placebo group) take two tablets of placebo three times per day for 12 weeks.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M81.09)Postmenopausal osteoporosis, site unspecified
Rare Disease	No
Inclusion Criteria	Gender Female
	Age 55Year~85Year
	Description 1. Ambulatory females aged 55 to 85 years 2. Postmenopausal women (at least 12 months after last menstrual period) 3. Bone mineral density ≤ -2.5 standard deviation (SD) 4. Subject who decide to participate in clinical trials and signed a consent form after providing with detailed explanation
Exclusion Criteria	1. Serum alkaline phosphatase > 2 times of upper limit of normal range 2. Subject who has liver disease (AST or ALT > 2 times of upper limit of normal range) 3. Subject who has kidney disease (serum creatinine > 2.0 mg/dl) 4. Hypercalcemia (Ca > 10.5 mg/dl) 5. Subject who has uncontrolled chronic disorders that may affect bone metabolism (For example, chronic liver disease, alcoholism, primary hyperparathyroidism, malignant tumor etc.) 6. Subject who took pharmacotherapy (except calcium and vitamin D) for osteoporosis within 3 months 7. Subject who took injection therapy for osteoporosis within 6 months 8. Subject who took drugs that may affect calcium metabolism in bones for more than 6 months (For example, systematic steroids, diuretics etc.) (However, it is possible to participate subjects who did not take banned drugs except anticonceptive injection within the last 3 months before screening) 9. Subject with metabolic bone disease except osteoporosis 10. Subject with mental disorders who cannot follow compliance details of clinical trials
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Bone Mineral Density(BMD)- Dual Energy X-ray Absorptiometry(DXA)
Timepoint	Visit1(Screening), Visit5(12 weeks after randomization)
Secondary Outcome(s) 1
Outcome	Osteoporosis markers : Bone Specific Alkaline Phosphatase, serum bone-derived degradation products of type I collagen C-telopeptide, Insunlin-like Growth Factor-1, N-telopeptide, Osteocalcin
Timepoint	Visit1(Screening), Visit5(12 weeks after randomization)
Secondary Outcome(s) 2
Outcome	Questionnaire about the deficiency syndrome of kidney index (DSKI)
Timepoint	Visit2(Randomization), Visit5(12 weeks after randomization)
Secondary Outcome(s) 3
Outcome	Questionnaire about health-related quality of life status (EQ-5D index)
Timepoint	Visit2(Randomization), Visit5(12 weeks after randomization)
Secondary Outcome(s) 4
Outcome	Adverse event
Timepoint	Visit3(4 weeks after randomization), Visit4(8 weeks after randomization), Visit5(12 weeks after randomization)
Secondary Outcome(s) 5
Outcome	Laboratory experiment
Timepoint	Visit1(Screening), Visit4(8 weeks after randomization), Visit5(12 weeks after randomization)
Secondary Outcome(s) 6
Outcome	Vital sign
Timepoint	Visit1(Screening), Visit2(Randomization), Visit4(8 weeks after randomization), Visit5(12 weeks after randomization)
Secondary Outcome(s) 7
Outcome	ECG
Timepoint	Visit1(Screening), Visit5(12 weeks after randomization)

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

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