To study the efficacy of strontium ranelate on the healing of surgically fixed diaphyseal tibial fractures and compare it to placebo

Efficacy of Strontium Ranelate versus placebo on time to fracture healing of tibial fractures in adults

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000876998

Enrollment

100

Registered

2011-08-17

Start date

2011-08-15

Completion date

2012-04-24

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Strontium Ranelate is approved for treatment of osteoporosis. Its mode of action is thought to be a combination of anti resorptive and anabolic on bone. The bone forming ability has been documented in animal studies as well as in the increase in level of P1NP (A bone formation marker). There are anecdotal reports that it enhances fracture healing in humans but very little prospective data is present. The purpose of this study is to study the efficacy of strontium ranelate in the dose of 2gm daily on the healing of surgically fixed diaphyseal tibial fractures and compare it to placebo.

Interventions

The purpose of this study is to study the efficacy of strontium ranelate in the dose of 2gm daily on the healing of surgically fixed diaphyseal tibial fractures and compare it to placebo. The subjects will receive strontium ranelate for a period of 3months commencing from the 1st day after fracture fixation. Strontium ranelate will be administered in an oral suspension form with yellow granules in a sachet to be mixed in 30ml water.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

All adult patients between 18 and 60 years of age presenting with closed diaphysial tibial fractures, amenable to fixation with a Dynamic Compression Plate / Locking Compression Plate

Exclusion criteria

All open fractures Patients under 18 yrs or over 60 yrs Metaphyseal /periarticular fractures Patients with previous procedures in that limb Fractures requiring bone grafting Pregnant patients Patients with renal impairment

Outcome results