The Efficacy and Safety of BHH10 in Patients with Osteoporosis

• Register: KCT
• Last refreshed on: 11 March 2019
• Main ID: KCT0001842
• Date of registration: 2016-03-14
• Prospective Registration: Yes
• Primary sponsor: Hanpoong Pharm & Foods
• Public 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
• Date of first enrolment: 2016-03-24
• Target sample size: 168
• Recruitment status: Recruiting
• URL: http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=7421
• Study type: Interventional Study
• Study design: Primary Purpose : Treatment, Intervention Model : Parallel, Blinding/Masking : Double, Blinding Target : Subject, Investigator, Caregiver, Outcome Accessor, Allocation : RCT
• Phase: Phase2

Countries of recruitment

Korea, Republic of

Contacts

• Name: Seunghoon Lee
• Affiliation: Kyung Hee University Oriental Medical Center

• Name: Jae-dong Lee
• Affiliation: Kyung Hee University Oriental Medical Center

Key inclusion & exclusion criteria

Inclusion criteria: 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

Age minimum: 55(Year)
Age maximum: 85(Year)
Gender: Female

Health Condition(s) or Problem(s) studied

Diseases of the musculo-skeletal system and connective tissue

Intervention(s)

Drug : 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.

Primary Outcome(s)

Bone Mineral Density(BMD)- Dual Energy X-ray Absorptiometry(DXA)

Secondary Outcome(s)

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

Vital sign

Questionnaire about health-related quality of life status (EQ-5D index)

Laboratory experiment

Adverse event

Questionnaire about the deficiency syndrome of kidney index (DSKI)

Source(s) of Monetary Support

Ministry of Health & Welfare

Ethics review

Status: Submitted approval
Approval date:
Contact:

Kyung Hee University Korean Medicine Hospital Institutional Review Board