The Efficacy and Safety of BHH10 in Patients with Osteoporosis

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0001842

Enrollment

168

Registered

2016-03-14

Start date

2016-03-24

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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

Eligibility

Sex/Gender

Female

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Bone Mineral Density(BMD)- Dual Energy X-ray Absorptiometry(DXA)	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactSeunghoon Lee

Kyung Hee University Oriental Medical Center

aimforyou@hanmail.net+82-2-958-9202

Outcome results