Role of Strontium Ranelate in Proximal Femur Fragility Fractures.

Study Overview
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Brief Summary
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This study is being conducted with the aim of comparing the time to bone healing after surgery for fragility fractures of proximal femur between patients receiving strontium ranelate and placebo. Patients recruited are of 60 years of age and above. Bone healing will be assessed on clinical parameters when patient is able to ambulate full weight bearing without pain and on Xray images using RUSH score. Moreover Dexa scan will be performed pre-operatively and at 3 months postoperatively. The findings of this study will help in setting up guidelines for treatment of fragility proximal femur fractures in our population as there is still paucity of literature on effectiveness of strontium ranelate from our part of the world.

Official Title
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Role of Strontium Ranelate in Radiological Healing of Proximal Femur Fractures. A Phase IV Double Blinded Randomized Controlled Trial

Conditions
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Fragility Fracture, Femur; Fracture, Pertrochanteric, Clinical Trial

Intervention / Treatment
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* Drug: Strontium Ranelate
* Drug: Lacto-N-Hexaose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with age =/> 60 years with proximal femur fracture including per-trochanteric, sub-trochanteric and neck of femur fractures amnebale to ORIF. ORIF will include hip cannulated screws, dynamic hip screw and intra-medullary nails. Exclusion Criteria: Patients with metabolic bone diseases. Patients with pathological fractures like tumor, osteopetrosis etc. Patients with prior Ischemic heart diseases and underwent PCI or CABG

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Strontium group<br>Trial drug given in the form of sachet 2gm/sachet once every day | Drug: Strontium Ranelate<br>* Dual mode of action, anabolic and anti-resorptive<br>* Other names: placebo;|
| Placebo Comparator: Placebo (Lactose)<br>Look, smell, taste alike lactose 2gm/sachet in form of sachet | Drug: Lacto-N-Hexaose<br>* Placebo look alike drug<br>* Other names: Lactose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Radiological healing on radiographs | Difference in RUSH (Radiological Healing score for hip) score measured at 12 weeks and 24 weeks | 12 weeks and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change Bone mineral density through DEXA scan | Difference in bone density T scores between pre-op and 3 months studies | pre-operatively or peri-admission and at 3 months |