Health Condition 1: S525- Fracture of lower end of radius
Conditions
Interventions
Intervention1: Teriparatide: Dose- 20-mcg
Duration-Daily (preferably at late evening at the same time)for the treatment duration of the study (08 weeks)
Mode of administration-subcutaneous injection
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female participants between 18 and 65 of age (both inclusive) at the time of screening and willing to sign a written informed consent form for participation in the study and agree to comply with study requirements. 2. Patient who had sustained a unilateral dorsally angulated distal radial fracture (Collesâ??) within the past 7 days as radiologically evaluated by the Investigator and must have received/planned for conservative treatment of the fracture., 3. Patient is willing and able to satisfactorily use a pen-type delivery system or is willing to receive daily subcutaneous injections from a care partner trained to use the injector. 4. Male patients of child begetting potential and female patients of child bearing potential must be practicing adequate contraception. Such female patients must not be pregnant or lactating and must have a negative serum pregnancy test at screening and negative urine pregnancy test at randomization.
Exclusion criteria
Exclusion criteria: 1. Patients in need of surgery for the current distal radial fracture. 2. Patient who had sustained previous fractures or bone surgery in the currently fractured distal forearm or had joint diseases that affect the function of the wrist and/or hand of the injured arm. 3. Multiple fractures and secondary soft tissue infections at the site(s) of injury. 4. Currently receiving any treatment for osteoporosis, including bisphoshonates, calcitonin, teriparatide, estrogen and estrogenic-like compounds except calcium and vitamin D used for fractures sustained without trauma in osteopenic individuals. 5. Diseases other than primary osteoporosis that affect bone metabolism or responses to therapy, including an elevated serum calcium or alkaline phosphatase levels based on the laboratory reference range. 6. Any known case of active cancer, previous primary skeletalmalignancy (including osteosarcoma), or skeletal exposure to therapeutic irradiation or a history of a malignant neoplasm in the 5 years prior to the study (with the exception of superficial basal cell carcinoma or squamous cell carcinoma), and carcinoma in situ of the uterine cervix treated less than 1 year prior to the study. 7. Patient currently on and in need of continuing medication like immunosuppressants, digitalis, thiazide and furosemide. 8. Any other significant co-morbidity, severe or chronically disabling condition (other than the distal radial fracture) that in Investigatorâ??s opinion precludes patient participation considering undue risk to health. 9. A known allergy to past intake of teriparatide or any form of PTH hormone or analogue. 10. Last participation in any other clinical study or participation in any other trial involving investigational medicinal product within 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to radiographic healing, defined as the interval in days between the occurrence of the fracture and the time when bridging in three of four cortices seen on X-ray images.Timepoint: Upon confirmation of healing as per Protocol definition | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Radiographic evidence of time to healing of four cortices bridging, early and partial endosteal healing, and trabecular union. â?¢ Percentage of patients showing radiographic healing as per the definition at 8 weeks of treatment. â?¢ Functional assessments based on the self-administered Patient-Rated Wrist Evaluation (PRWE) questionnaire. Timepoint: Upon confirmation of healing as per Protocol definition ;SAFETY: â?¢ Reports of adverse events (AEs), serious adverse events (SAEs), early discontinuations because of AEs, clinical laboratory tests, and physical examination.Timepoint: Throughout the study and a follow-up period without treatment for 4 weeks upon achieving healing as per Protocol definition of 8 weeks of study treatment, whichever is earlier. | — |
Countries
India
Contacts
Public ContactDr Randhirsinh Solanki
Lambda Therapeutic Research Ltd.
Outcome results
None listed