The Efficacy and Safety of BHH10 in Patients with Osteoporosis

Not Applicable

Recruiting

Conditions: Diseases of the musculo-skeletal system and connective tissue

Registration Number: KCT0001842

Lead Sponsor: Hanpoong Pharm & Foods

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 168

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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 ;Questionnaire about the deficiency syndrome of kidney index (DSKI) ;Questionnaire about health-related quality of life status (EQ-5D index);Adverse event;Laboratory experiment;Vital sign