Role of Strontium Ranelate in Proximal Femur Fragility Fractures. (STRONG)

Aga Khan University Hospital, Pakistan

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Lacto-N-Hexaose; Drug: Strontium Ranelate

Study type: Interventional

Funder types: Other

Identifiers

NCT05712616

6189

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 60 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Strontium group

Active Comparator group

Description:

Trial drug given in the form of sachet 2gm/sachet once every day

Treatment:

Drug: Strontium Ranelate

Placebo (Lactose)

Placebo Comparator group

Description:

Look, smell, taste alike lactose 2gm/sachet in form of sachet

Treatment:

Drug: Lacto-N-Hexaose