Health Condition 1: M800- Age-related osteoporosis with current pathological fracture
Conditions
Interventions
Intervention1: Standard treatment and Teriparatide: Inj. Teriparatide once daily, Subcutaneous for 84 10 days
Control Intervention1: Standard treatment: As per investigator discretion for 84 10 d
Sponsors
Alkem Laboratories Alkem House
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female aged between 60 years and 80 years 2. Diagnosis/history of osteoporosis, as per physician s judgement 3. At least 84 10 days of study treatment for fracture 4. Administered either standard treatment along with teriparatide or standard treatment alone
Exclusion criteria
Exclusion criteria: 1. Incomplete medical records with respect to the required study parameters 2. Premenopausal women, as per physician s judgement 3. Callus formation evident at baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients with callus formation after 28 10, 56 10, and 84 10 days of treatment 2. Proportion of patients with rich, intermediate, or poor callus after 28 10, 56 10, and 84 10 days of treatment 3. Time to callus formation from treatment initiation (baseline)Timepoint: 28 10 days, 56 10 days, 84 10 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with adverse events (AEs) and serious adverse events (SAEs) after treatment initiationTimepoint: 1.28 10 days 2.56 10 days 3.84 10 days | — |
Countries
India
Contacts
Public ContactDr Monjori Mitra
Medclin Research Pvt Ltd
Outcome results
None listed