Effect of Teriparatide in Fracture Healing in Lower Limbs- An Interventional Study RC01-RC04
Dr Girish Sahni,
94, Ajit Nagar, Patiala, Punjab, India.
Introduction: Many of the trauma patients presenting to the orthopaedic departments suffer from lower limb fractures. This often leads to prolonged period of morbidity and absence from work. Fracture healing can be delayed in elderly patients, postmenopausal women and in communited fractures. Teriparatide (TPH) given subcutaneously for 6 to 9 months, in such cases, may promote clinical and radiological union of bone.
Aim: To know the effect of TPH in improving clinical and radiological union and also to evaluate early weight bearing, improvement in pain and functional outcome.
Materials and Methods: In this prospective interventional study, a total of 125 patients were initially enrolled for the study and then after meeting inclusion criteria total 104 patients were selected for the study. They were allocated into two groups by randomisation by 1:1 method-group A was test group of 52 cases in which subcutaneous injection TPH 20 mcg daily (for six months) was given along with standard dosage of calcium and vitamin D; while in 52 cases in group B (control group) only calcium and vitamin D were given. Injection TPH was started within 10 days of fracture and given for six months. No placebo injection was given in control group. Time to weight bearing, time to clinical and radiological union and pain by Visual Analogue Score (VAS) were noted at regular follow-up at one month, three months, six months and 12 months and were compared in both the groups. Functional outcome by Disabilities of the Arm, Shoulder and Hand (DASH) score was noted as an additional tool, as DASH score questionnaire shows many activities of daily living that require mobility and stability of lower limb too. Adverse reactions were noted and compared within test and control groups. The collected data were analysed using International Business Machines (IBM) Statistical Package for the Social Sciences (SPSS) version 22.0 software and Mann-Whitney U test was used to calculate p-value.
Results: Average time period for full weight bearing with or without support for test group A was 11±2.7 weeks and 16±1.8 weeks in control group B (p-0.001). Average time to clinical union in test group was 12±1.9 weeks and in control group 16±2.2 weeks (p-0.001). Average time to radiological union was 13±1.4 weeks in test group while 22±2.2 weeks in control group (p-0.001). Pain score by VAS and functional outcome by DASH were improved in test group (p-0.001). There was no difference in adverse reactions in both the groups (p>0.05).
Conclusion: Regular intake of TPH 20 mcg subcutaneous daily for six months can reduce time to clinical and radiological fracture union, promote early weight bearing and provide better pain control. Hence, better functional outcome and prefracture ambulatory status can be achieved with no significant adverse events.