An exploratory study to assess the effect of Ayush Osto on the bone turnover markers among post-menopausal osteoporotic women.
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in Bone Formation [SerumProcollagen Type I N-terminal Propeptide, Alkaline phosphatase (Total and Bone specific), Osteocalcin] and Bone Resorption (Serum CTX) Markers level at the end of treatment i.e. on 180th day as compared to baseline.
Study Overview
Brief Summary
Osteoporosis is a disease that is characterized by a low bone mass and a micro architectural deterioration of the bone tissue, which leads to enhanced bone fragility and a consequent increase in the fractures. The National Osteoporosis Foundation (NOF) estimates there are 9.1 million women with osteoporosis and an additional 26 million with low bone mass. This far exceeds the estimated number of men with osteoporosis, 2.8 million, and with low bone mass, 14.4 million. [1] Worldwide, the lifetime risk for women to have an osteoporotic fracture is 30-40%. [2] One out of two Indian women above the age of 50 years and one out of five Indian men above the age of 65 years are at risk of osteoporosis.[3,4] In India, osteoporotic fractures are a major cause of morbidity and mortality in the elderly, as in the West. Asthikshaya is a condition in which there is a decrease in the Asthidhatu (Bone tissue), leading to many undesirable effects. It can be compared with osteoporosis, in which there is a decrease in Bone Mineral Density (BMD), leading to an increased risk of fractures. Ayush Osto is an Ayurvedic formulation for the management of Asthikshaya (Osteoporosis & Osteopenia undertaken for drug development by the Council through a systematic process of drug development.
| Keeping in view the above scenario, a study has been designed which is intended to evaluate the effect of Ayush Osto on the bone turnover markers (bone formative-Serum PINP, Alkaline phosphatase (Total and Bone specific), Osteocalcin and bone resorptive-serum CTX) among postmenopausal osteoporosis (Asthikshaya) women. |
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 35.00 Year(s) to 70.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Women age less than 70 years with history of spontaneous amenorrhea for equal or more than 12 months.
- •B M D T score at or below -2.5 measured by DXA Scan of Hip region proximal femur.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Bone Formation [SerumProcollagen Type I N-terminal Propeptide, Alkaline phosphatase (Total and Bone specific), Osteocalcin] and Bone Resorption (Serum CTX) Markers level at the end of treatment i.e. on 180th day as compared to baseline.
Time Frame: Change in Bone Formation [SerumProcollagen Type I N-terminal Propeptide, Alkaline phosphatase (Total and Bone specific), Osteocalcin] and Bone Resorption (Serum CTX) Markers level at the end of treatment i.e. on 180th day as compared to baseline.
Secondary Outcomes
- Change in Quality of Life score by using Qualeffo-41 questionnaire at the end of treatment as compared to baseline.(Incidence of fractures associated with the osteoporosis during the study.)
Investigators
Dr Rinku Tomar
Central Council for Research in Ayurvedic Sciences